Re: [PSES] EU DoC on Thumb Drive?

2021-05-14 Thread Carl Newton

Thanks to all for your responses.  They are very helpful.

Best regards,

Carl

On 5/14/2021 4:54 PM, Richard Nute wrote:


The symbol ISO 7000-3500  "Electronic instructions for use" is for 
medical equipment.  The related EU regulation is:


https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:072:0028:0031:EN:PDF 
<https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:072:0028:0031:EN:PDF>


This regulation specifies, among other requirements, “exclusive use by 
professional users” and requires a risk assessment.


If your equipment is not medical equipment, you cannot (or should not) 
use the symbol.


I know of no regulation that prohibits electronic instructions, but 
standards and regulations specify statements which are traditionally 
printed on paper and which must accompany the equipment.


Stay safe, and best regards,

Rich

*From:*Chuck August-McDowell 
*Sent:* Friday, May 14, 2021 11:42 AM
*To:* EMC-PSTC@LISTSERV.IEEE.ORG
*Subject:* Re: [PSES] EU DoC on Thumb Drive?

Seconding Brian’s motion to allow the QR Code as an approved method to 
provide DoC information.


We recently Include Symbol ISO 7000-3500  "Electronic instructions for 
use" and the QR Code in the Symbol table in the basic safety 
information provided on paper with each product.


Currently provide paper DoC also.

Symbol ISO 7000-3500 Function/description :

To indicate on product or product packaging that relevant information 
for use of the product is available in electronic form rather than, or 
in addition to, printed paper form.


Link https://www.iso.org/obp/ui#iso:grs:7000:3500 
<https://www.iso.org/obp/ui#iso:grs:7000:3500>


Respectfully,

Chuck August-McDowell

*From:*Pete Perkins <0061f3f32d0c-dmarc-requ...@listserv.ieee.org 
<mailto:0061f3f32d0c-dmarc-requ...@listserv.ieee.org>>

*Sent:* Friday, May 14, 2021 10:51 AM
*To:* EMC-PSTC@LISTSERV.IEEE.ORG <mailto:EMC-PSTC@LISTSERV.IEEE.ORG>
*Subject:* Re: [PSES] EU DoC on Thumb Drive?

[EXTERNAL EMAIL]

Brian,    This is another method that needs to be on the list of 
accepted paths to show compliance, in my opinion.


   Of course, the acceptance for any such methods need to 
come from the Euro Commission, meeting Euro legal requirements and 
having the buy-in of all the interested parties – such as the Customs 
Officers who are charged with either clearing or refusing entry to CE 
marked items and are looking for further justification (MDoC in 
particular).


   I see this as a long slog to get anywhere unless some 
very influential group that the EU folks admire takes it on with a 
passion.  Do you know anyone at the WTO?


   I guess, if your company is gutsy enough you can try it 
and see how it goes; sometimes changes are made in fact and later the 
paperwork catches up.


:>) br,  Pete

Peter E Perkins, PE

Principal Product Safety & Regulatory Affairs Consultant

PO Box 1067

Albany, ORe 97321-0413

503/452-1201

IEEE Life Fellow

IEEE PSES 2020 Distinguished Lecturer

www.researchgate.net 
<http://www.researchgate.net/Peter%20Perkins>search my name


p.perk...@ieee.org <mailto:p.perk...@ieee.org>

Entropy ain’t what it used to be

*From:*Brian Ceresney <mailto:bceres...@delta-q.com>>

*Sent:* Friday, May 14, 2021 10:40 AM
*To:* Pete Perkins mailto:peperkin...@cs.com>>; 
EMC-PSTC@LISTSERV.IEEE.ORG <mailto:EMC-PSTC@LISTSERV.IEEE.ORG>

*Subject:* RE: [PSES] EU DoC on Thumb Drive?

Hello All,

Apologies for “hijacking the thread”, but we’ve been considering the 
now-ubiquitous(post pandemic) QR Code as a method of delivering 
information about the product – user manual, declarations for the EU, 
MC documentation, etc. A small accessible code label could really help 
make information accessible to the customer, using the cell phone.


Does this also still fall under the “not-yet” category?

Best Regards,

Brian C.

*From:*Pete Perkins <0061f3f32d0c-dmarc-requ...@listserv.ieee.org 
<mailto:0061f3f32d0c-dmarc-requ...@listserv.ieee.org>>

*Sent:* Friday, May 14, 2021 10:34 AM
*To:* EMC-PSTC@LISTSERV.IEEE.ORG <mailto:EMC-PSTC@LISTSERV.IEEE.ORG>
*Subject:* Re: [PSES] EU DoC on Thumb Drive?

CAUTION:This email originated from outside of the organization. Do not 
click links or open attachments unless you recognize the sender and 
know the content is safe.


Carl et al,

This question has been asked before and the official answer seems to 
still be ‘not yet’.


Some folks in the IEEE PSES TAC/ITE interest group have been working 
to put together a draft proposal that would allow digital 
documentation (thumb drive or even website) to meet the requirements.  
As noted, there are many interests in this way outside our usual 
working circle. Nothing has developed from this yet; maybe sometime in 
the future.


Keep your hopes up though; pie in the sky is what keeps us going some 
time.


:

Re: [PSES] EU DoC on Thumb Drive?

2021-05-14 Thread Richard Nute
 

 

The symbol ISO 7000-3500  "Electronic instructions for use" is for medical 
equipment.  The related EU regulation is:

 

https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:072:0028:0031:EN:PDF

 

This regulation specifies, among other requirements, “exclusive use by 
professional users” and requires a risk assessment.   

 

If your equipment is not medical equipment, you cannot (or should not) use the 
symbol.  

 

I know of no regulation that prohibits electronic instructions, but standards 
and regulations specify statements which are traditionally printed on paper and 
which must accompany the equipment.

 

Stay safe, and best regards,

Rich

 

 

From: Chuck August-McDowell  
Sent: Friday, May 14, 2021 11:42 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] EU DoC on Thumb Drive?

 

Seconding Brian’s motion to allow the QR Code as an approved method to provide 
DoC information.

 

We recently Include Symbol ISO 7000-3500  "Electronic instructions for use" and 
the QR Code in the Symbol table in the basic safety information provided on 
paper with each product.

Currently provide paper DoC also.

 

Symbol ISO 7000-3500 Function/description : 

To indicate on product or product packaging that relevant information for use 
of the product is available in electronic form rather than, or in addition to, 
printed paper form. 

 

Link  <https://www.iso.org/obp/ui#iso:grs:7000:3500> 
https://www.iso.org/obp/ui#iso:grs:7000:3500

 

 

Respectfully,

 

Chuck August-McDowell

 

 

From: Pete Perkins < <mailto:0061f3f32d0c-dmarc-requ...@listserv.ieee.org> 
0061f3f32d0c-dmarc-requ...@listserv.ieee.org> 
Sent: Friday, May 14, 2021 10:51 AM
To:  <mailto:EMC-PSTC@LISTSERV.IEEE.ORG> EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] EU DoC on Thumb Drive?

 

[EXTERNAL EMAIL]

Brian,This is another method that needs to be on the list of accepted paths 
to show compliance, in my opinion.  

 

   Of course, the acceptance for any such methods need to come from 
the Euro Commission, meeting Euro legal requirements and having the buy-in of 
all the interested parties – such as the Customs Officers who are charged with 
either clearing or refusing entry to CE marked items and are looking for 
further justification (MDoC in particular).  

   I see this as a long slog to get anywhere unless some very 
influential group that the EU folks admire takes it on with a passion.  Do you 
know anyone at the WTO?  

 

   I guess, if your company is gutsy enough you can try it and see 
how it goes; sometimes changes are made in fact and later the paperwork catches 
up.  

 

:>) br,  Pete

 

Peter E Perkins, PE

Principal Product Safety & Regulatory Affairs Consultant

PO Box 1067

Albany, ORe  97321-0413

 

503/452-1201

 

IEEE Life Fellow

IEEE PSES 2020 Distinguished Lecturer

 <http://www.researchgate.net/Peter%20Perkins> www.researchgate.net search my 
name

 <mailto:p.perk...@ieee.org> p.perk...@ieee.org

 

 

Entropy ain’t what it used to be

 

From: Brian Ceresney < <mailto:bceres...@delta-q.com> bceres...@delta-q.com> 
Sent: Friday, May 14, 2021 10:40 AM
To: Pete Perkins < <mailto:peperkin...@cs.com> peperkin...@cs.com>;  
<mailto:EMC-PSTC@LISTSERV.IEEE.ORG> EMC-PSTC@LISTSERV.IEEE.ORG
Subject: RE: [PSES] EU DoC on Thumb Drive?

 

Hello All, 

Apologies for “hijacking the thread”, but we’ve been considering the 
now-ubiquitous(post pandemic) QR Code as a method of delivering information 
about the product – user manual, declarations for the EU, MC documentation, 
etc. A small accessible code label could really help make information 
accessible to the customer, using the cell phone. 

Does this also still fall under the “not-yet” category?

 

Best Regards, 

Brian C.

From: Pete Perkins < <mailto:0061f3f32d0c-dmarc-requ...@listserv.ieee.org> 
0061f3f32d0c-dmarc-requ...@listserv.ieee.org> 
Sent: Friday, May 14, 2021 10:34 AM
To:  <mailto:EMC-PSTC@LISTSERV.IEEE.ORG> EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] EU DoC on Thumb Drive?

 

CAUTION: This email originated from outside of the organization. Do not click 
links or open attachments unless you recognize the sender and know the content 
is safe.

 

Carl et al,

 

   This question has been asked before and the official answer 
seems to still be ‘not yet’.  

 

   Some folks in the IEEE PSES TAC/ITE interest group have been 
working to put together a draft proposal that would allow digital documentation 
(thumb drive or even website) to meet the requirements.  As noted, there are 
many interests in this way outside our usual working circle.  Nothing has 
developed from this yet; maybe sometime in the future.  

 

   Keep your hopes up though; pie in the sky is what keeps us going 
some time.   

 

:>) br,

Re: [PSES] EU DoC on Thumb Drive?

2021-05-14 Thread Chuck August-McDowell
Seconding Brian’s motion to allow the QR Code as an approved method to provide 
DoC information.

We recently Include Symbol ISO 7000-3500  "Electronic instructions for use" and 
the QR Code in the Symbol table in the basic safety information provided on 
paper with each product.
Currently provide paper DoC also.

Symbol ISO 7000-3500 Function/description :
To indicate on product or product packaging that relevant information for use 
of the product is available in electronic form rather than, or in addition to, 
printed paper form.

Link https://www.iso.org/obp/ui#iso:grs:7000:3500

Respectfully,

Chuck August-McDowell

From: Pete Perkins <0061f3f32d0c-dmarc-requ...@listserv.ieee.org>
Sent: Friday, May 14, 2021 10:51 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] EU DoC on Thumb Drive?


[EXTERNAL EMAIL]
Brian,This is another method that needs to be on the list of accepted paths 
to show compliance, in my opinion.

   Of course, the acceptance for any such methods need to come from 
the Euro Commission, meeting Euro legal requirements and having the buy-in of 
all the interested parties – such as the Customs Officers who are charged with 
either clearing or refusing entry to CE marked items and are looking for 
further justification (MDoC in particular).
   I see this as a long slog to get anywhere unless some very 
influential group that the EU folks admire takes it on with a passion.  Do you 
know anyone at the WTO?

   I guess, if your company is gutsy enough you can try it and see 
how it goes; sometimes changes are made in fact and later the paperwork catches 
up.

:>) br,  Pete

Peter E Perkins, PE
Principal Product Safety & Regulatory Affairs Consultant
PO Box 1067
Albany, ORe  97321-0413

503/452-1201

IEEE Life Fellow
IEEE PSES 2020 Distinguished Lecturer
www.researchgate.net<http://www.researchgate.net/Peter%20Perkins> search my name
p.perk...@ieee.org<mailto:p.perk...@ieee.org>


Entropy ain’t what it used to be

From: Brian Ceresney mailto:bceres...@delta-q.com>>
Sent: Friday, May 14, 2021 10:40 AM
To: Pete Perkins mailto:peperkin...@cs.com>>; 
EMC-PSTC@LISTSERV.IEEE.ORG<mailto:EMC-PSTC@LISTSERV.IEEE.ORG>
Subject: RE: [PSES] EU DoC on Thumb Drive?

Hello All,
Apologies for “hijacking the thread”, but we’ve been considering the 
now-ubiquitous(post pandemic) QR Code as a method of delivering information 
about the product – user manual, declarations for the EU, MC documentation, 
etc. A small accessible code label could really help make information 
accessible to the customer, using the cell phone.
Does this also still fall under the “not-yet” category?

Best Regards,
Brian C.
From: Pete Perkins 
<0061f3f32d0c-dmarc-requ...@listserv.ieee.org<mailto:0061f3f32d0c-dmarc-requ...@listserv.ieee.org>>
Sent: Friday, May 14, 2021 10:34 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG<mailto:EMC-PSTC@LISTSERV.IEEE.ORG>
Subject: Re: [PSES] EU DoC on Thumb Drive?

CAUTION: This email originated from outside of the organization. Do not click 
links or open attachments unless you recognize the sender and know the content 
is safe.

Carl et al,

   This question has been asked before and the official answer 
seems to still be ‘not yet’.

   Some folks in the IEEE PSES TAC/ITE interest group have been 
working to put together a draft proposal that would allow digital documentation 
(thumb drive or even website) to meet the requirements.  As noted, there are 
many interests in this way outside our usual working circle.  Nothing has 
developed from this yet; maybe sometime in the future.

   Keep your hopes up though; pie in the sky is what keeps us going 
some time.

:>) br,  Pete

Peter E Perkins, PE
Principal Product Safety & Regulatory Affairs Consultant
PO Box 1067
Albany, ORe  97321-0413

503/452-1201

IEEE Life Fellow
IEEE PSES 2020 Distinguished Lecturer
www.researchgate.net<http://www.researchgate.net/Peter%20Perkins> search my name
p.perk...@ieee.org<mailto:p.perk...@ieee.org>


Entropy ain’t what it used to be

From: Charlie Blackham 
mailto:char...@sulisconsultants.com>>
Sent: Friday, May 14, 2021 1:17 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG<mailto:EMC-PSTC@LISTSERV.IEEE.ORG>
Subject: Re: [PSES] EU DoC on Thumb Drive?

Carl

A number of other Directives such as RED and Machinery also require DoC to be 
provided with equipment

In the absence of Guidance that says you can provide it electronically it is 
best to work on the basis that you must not – Customs / Market enforcement will 
expect to be able to find the DoC if they inspect the product, and if it’s not 
in print format they won’t be able to as they’re not going to load up a CD or 
USB stick, and you will be considered to be shipping “non-compliant” product

Best regards
Charlie

Charlie Blackham
Sulis Consultants Ltd
Tel: +44 (0)7946 624317
Web: https:/

Re: [PSES] EU DoC on Thumb Drive?

2021-05-14 Thread Pete Perkins
Brian,This is another method that needs to be on the list of accepted paths 
to show compliance, in my opinion.  

 

   Of course, the acceptance for any such methods need to come from 
the Euro Commission, meeting Euro legal requirements and having the buy-in of 
all the interested parties – such as the Customs Officers who are charged with 
either clearing or refusing entry to CE marked items and are looking for 
further justification (MDoC in particular).  

   I see this as a long slog to get anywhere unless some very 
influential group that the EU folks admire takes it on with a passion.  Do you 
know anyone at the WTO?  

 

   I guess, if your company is gutsy enough you can try it and see 
how it goes; sometimes changes are made in fact and later the paperwork catches 
up.  

 

:>) br,  Pete

 

Peter E Perkins, PE

Principal Product Safety & Regulatory Affairs Consultant

PO Box 1067

Albany, ORe  97321-0413

 

503/452-1201

 

IEEE Life Fellow

IEEE PSES 2020 Distinguished Lecturer

 <http://www.researchgate.net/Peter%20Perkins> www.researchgate.net search my 
name

 <mailto:p.perk...@ieee.org> p.perk...@ieee.org

 

 

Entropy ain’t what it used to be

 

From: Brian Ceresney  
Sent: Friday, May 14, 2021 10:40 AM
To: Pete Perkins ; EMC-PSTC@LISTSERV.IEEE.ORG
Subject: RE: [PSES] EU DoC on Thumb Drive?

 

Hello All, 

Apologies for “hijacking the thread”, but we’ve been considering the 
now-ubiquitous(post pandemic) QR Code as a method of delivering information 
about the product – user manual, declarations for the EU, MC documentation, 
etc. A small accessible code label could really help make information 
accessible to the customer, using the cell phone. 

Does this also still fall under the “not-yet” category?

 

Best Regards, 

Brian C.

From: Pete Perkins <0061f3f32d0c-dmarc-requ...@listserv.ieee.org 
<mailto:0061f3f32d0c-dmarc-requ...@listserv.ieee.org> > 
Sent: Friday, May 14, 2021 10:34 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG <mailto:EMC-PSTC@LISTSERV.IEEE.ORG> 
Subject: Re: [PSES] EU DoC on Thumb Drive?

 

CAUTION: This email originated from outside of the organization. Do not click 
links or open attachments unless you recognize the sender and know the content 
is safe.

 

Carl et al,

 

   This question has been asked before and the official answer 
seems to still be ‘not yet’.  

 

   Some folks in the IEEE PSES TAC/ITE interest group have been 
working to put together a draft proposal that would allow digital documentation 
(thumb drive or even website) to meet the requirements.  As noted, there are 
many interests in this way outside our usual working circle.  Nothing has 
developed from this yet; maybe sometime in the future.  

 

   Keep your hopes up though; pie in the sky is what keeps us going 
some time.   

 

:>) br,  Pete

 

Peter E Perkins, PE

Principal Product Safety & Regulatory Affairs Consultant

PO Box 1067

Albany, ORe  97321-0413

 

503/452-1201

 

IEEE Life Fellow

IEEE PSES 2020 Distinguished Lecturer

 <http://www.researchgate.net/Peter%20Perkins> www.researchgate.net search my 
name

 <mailto:p.perk...@ieee.org> p.perk...@ieee.org

 

 

Entropy ain’t what it used to be

 

From: Charlie Blackham mailto:char...@sulisconsultants.com> > 
Sent: Friday, May 14, 2021 1:17 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG <mailto:EMC-PSTC@LISTSERV.IEEE.ORG> 
Subject: Re: [PSES] EU DoC on Thumb Drive?

 

Carl

 

A number of other Directives such as RED and Machinery also require DoC to be 
provided with equipment

 

In the absence of Guidance that says you can provide it electronically it is 
best to work on the basis that you must not – Customs / Market enforcement will 
expect to be able to find the DoC if they inspect the product, and if it’s not 
in print format they won’t be able to as they’re not going to load up a CD or 
USB stick, and you will be considered to be shipping “non-compliant” product

 

Best regards

Charlie

 

Charlie Blackham

Sulis Consultants Ltd

Tel: +44 (0)7946 624317

Web: https://sulisconsultants.com/ 

Registered in England and Wales, number 05466247

 

From: Carl Newton mailto:emcl...@gmail.com> > 
Sent: 13 May 2021 20:36
To: EMC-PSTC@LISTSERV.IEEE.ORG <mailto:EMC-PSTC@LISTSERV.IEEE.ORG> 
Subject: [PSES] EU DoC on Thumb Drive?

 

Group,

I've not been able to find anything that suggests that the EU DoC can be 
provided with the product electronically for a medical device.  I sent an 
inquiry to the commission and received no response.  The MDD and MDR require 
that the DoC is shipped with each product  and I have a customer that would 
like to include it on a thumb drive document package that will ship with the 
device rather than a paper hard-copy.

Do any of you have experience with this question that you can share?  

Thanks in advance,

Carl

-
--

Re: [PSES] EU DoC on Thumb Drive?

2021-05-14 Thread Brian Ceresney
Hello All,
Apologies for “hijacking the thread”, but we’ve been considering the 
now-ubiquitous(post pandemic) QR Code as a method of delivering information 
about the product – user manual, declarations for the EU, MC documentation, 
etc. A small accessible code label could really help make information 
accessible to the customer, using the cell phone.
Does this also still fall under the “not-yet” category?

Best Regards,
Brian C.
From: Pete Perkins <0061f3f32d0c-dmarc-requ...@listserv.ieee.org>
Sent: Friday, May 14, 2021 10:34 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] EU DoC on Thumb Drive?

CAUTION: This email originated from outside of the organization. Do not click 
links or open attachments unless you recognize the sender and know the content 
is safe.

Carl et al,

   This question has been asked before and the official answer 
seems to still be ‘not yet’.

   Some folks in the IEEE PSES TAC/ITE interest group have been 
working to put together a draft proposal that would allow digital documentation 
(thumb drive or even website) to meet the requirements.  As noted, there are 
many interests in this way outside our usual working circle.  Nothing has 
developed from this yet; maybe sometime in the future.

   Keep your hopes up though; pie in the sky is what keeps us going 
some time.

:>) br,  Pete

Peter E Perkins, PE
Principal Product Safety & Regulatory Affairs Consultant
PO Box 1067
Albany, ORe  97321-0413

503/452-1201

IEEE Life Fellow
IEEE PSES 2020 Distinguished Lecturer
www.researchgate.net<http://www.researchgate.net/Peter%20Perkins> search my name
p.perk...@ieee.org<mailto:p.perk...@ieee.org>


Entropy ain’t what it used to be

From: Charlie Blackham 
mailto:char...@sulisconsultants.com>>
Sent: Friday, May 14, 2021 1:17 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG<mailto:EMC-PSTC@LISTSERV.IEEE.ORG>
Subject: Re: [PSES] EU DoC on Thumb Drive?

Carl

A number of other Directives such as RED and Machinery also require DoC to be 
provided with equipment

In the absence of Guidance that says you can provide it electronically it is 
best to work on the basis that you must not – Customs / Market enforcement will 
expect to be able to find the DoC if they inspect the product, and if it’s not 
in print format they won’t be able to as they’re not going to load up a CD or 
USB stick, and you will be considered to be shipping “non-compliant” product

Best regards
Charlie

Charlie Blackham
Sulis Consultants Ltd
Tel: +44 (0)7946 624317
Web: https://sulisconsultants.com/
Registered in England and Wales, number 05466247

From: Carl Newton mailto:emcl...@gmail.com>>
Sent: 13 May 2021 20:36
To: EMC-PSTC@LISTSERV.IEEE.ORG<mailto:EMC-PSTC@LISTSERV.IEEE.ORG>
Subject: [PSES] EU DoC on Thumb Drive?


Group,

I've not been able to find anything that suggests that the EU DoC can be 
provided with the product electronically for a medical device.  I sent an 
inquiry to the commission and received no response.  The MDD and MDR require 
that the DoC is shipped with each product  and I have a customer that would 
like to include it on a thumb drive document package that will ship with the 
device rather than a paper hard-copy.

Do any of you have experience with this question that you can share?

Thanks in advance,

Carl
-


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This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 
mailto:emc-p...@ieee.org>>

All emc-pstc postings are archived and searchable on the web at: 
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website: http://www.ieee-pses.org/
Instructions: http://www.ieee-pses.org/lis

Re: [PSES] EU DoC on Thumb Drive?

2021-05-14 Thread Pete Perkins
Carl et al,

 

   This question has been asked before and the official answer 
seems to still be ‘not yet’.  

 

   Some folks in the IEEE PSES TAC/ITE interest group have been 
working to put together a draft proposal that would allow digital documentation 
(thumb drive or even website) to meet the requirements.  As noted, there are 
many interests in this way outside our usual working circle.  Nothing has 
developed from this yet; maybe sometime in the future.  

 

   Keep your hopes up though; pie in the sky is what keeps us going 
some time.   

 

:>) br,  Pete

 

Peter E Perkins, PE

Principal Product Safety & Regulatory Affairs Consultant

PO Box 1067

Albany, ORe  97321-0413

 

503/452-1201

 

IEEE Life Fellow

IEEE PSES 2020 Distinguished Lecturer

 <http://www.researchgate.net/Peter%20Perkins> www.researchgate.net search my 
name

 <mailto:p.perk...@ieee.org> p.perk...@ieee.org

 

 

Entropy ain’t what it used to be

 

From: Charlie Blackham  
Sent: Friday, May 14, 2021 1:17 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] EU DoC on Thumb Drive?

 

Carl

 

A number of other Directives such as RED and Machinery also require DoC to be 
provided with equipment

 

In the absence of Guidance that says you can provide it electronically it is 
best to work on the basis that you must not – Customs / Market enforcement will 
expect to be able to find the DoC if they inspect the product, and if it’s not 
in print format they won’t be able to as they’re not going to load up a CD or 
USB stick, and you will be considered to be shipping “non-compliant” product

 

Best regards

Charlie

 

Charlie Blackham

Sulis Consultants Ltd

Tel: +44 (0)7946 624317

Web: https://sulisconsultants.com/ 

Registered in England and Wales, number 05466247

 

From: Carl Newton mailto:emcl...@gmail.com> > 
Sent: 13 May 2021 20:36
To: EMC-PSTC@LISTSERV.IEEE.ORG <mailto:EMC-PSTC@LISTSERV.IEEE.ORG> 
Subject: [PSES] EU DoC on Thumb Drive?

 

Group,

I've not been able to find anything that suggests that the EU DoC can be 
provided with the product electronically for a medical device.  I sent an 
inquiry to the commission and received no response.  The MDD and MDR require 
that the DoC is shipped with each product  and I have a customer that would 
like to include it on a thumb drive document package that will ship with the 
device rather than a paper hard-copy.

Do any of you have experience with this question that you can share?  

Thanks in advance,

Carl

-


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discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
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Attachments are not permitted but the IEEE PSES On

Re: [PSES] EU DoC on Thumb Drive?

2021-05-14 Thread Charlie Blackham
Carl

A number of other Directives such as RED and Machinery also require DoC to be 
provided with equipment

In the absence of Guidance that says you can provide it electronically it is 
best to work on the basis that you must not – Customs / Market enforcement will 
expect to be able to find the DoC if they inspect the product, and if it’s not 
in print format they won’t be able to as they’re not going to load up a CD or 
USB stick, and you will be considered to be shipping “non-compliant” product

Best regards
Charlie

Charlie Blackham
Sulis Consultants Ltd
Tel: +44 (0)7946 624317
Web: https://sulisconsultants.com/
Registered in England and Wales, number 05466247

From: Carl Newton 
Sent: 13 May 2021 20:36
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] EU DoC on Thumb Drive?


Group,

I've not been able to find anything that suggests that the EU DoC can be 
provided with the product electronically for a medical device.  I sent an 
inquiry to the commission and received no response.  The MDD and MDR require 
that the DoC is shipped with each product  and I have a customer that would 
like to include it on a thumb drive document package that will ship with the 
device rather than a paper hard-copy.

Do any of you have experience with this question that you can share?

Thanks in advance,

Carl
-


This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 
mailto:emc-p...@ieee.org>>

All emc-pstc postings are archived and searchable on the web at: 
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website: http://www.ieee-pses.org/
Instructions: http://www.ieee-pses.org/list.html (including how to 
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David Heald mailto:dhe...@gmail.com>>

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discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
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Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
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Mike Cantwell 

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Jim Bacher:  
David Heald: 


[PSES] EU DoC on Thumb Drive?

2021-05-13 Thread Carl Newton

Group,

I've not been able to find anything that suggests that the EU DoC can be 
provided with the product electronically for a medical device.  I sent 
an inquiry to the commission and received no response.  The MDD and MDR 
require that the DoC is shipped with each product  and I have a customer 
that would like to include it on a thumb drive document package that 
will ship with the device rather than a paper hard-copy.


Do any of you have experience with this question that you can share?

Thanks in advance,

Carl


-

This message is from the IEEE Product Safety Engineering Society emc-pstc discussion 
list. To post a message to the list, send your e-mail to 

All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 


Re: [PSES] EU-DoC - list of applied standards with full title

2012-11-19 Thread Kunde, Brian
I think this all begs the question, has anyone experienced any problems with 
their EU DOC by not providing the Standard's Title? If so, what was the 
objection and what was necessary to resolve it?

The official titles of directives and standards are often way too long and 
often more confusing then descriptive.

We reference directives and standards on our EU DOC by their number and date 
and follow it with a brief description and sometimes additional useful 
information. Such as:

EN 61010-1:2010   Safety of Laboratory Equipment

Or

EN55011:2007+A2:2007RF EmissionsGroup 1, Class A


The directives requirements are, a reference to the harmonized standards 
used, so I would think as long as you provide enough information so it is 
clear what the standards are you should be ok.

We think about what information our customers and others might want to see in 
the DOC and include it if we can. The more descriptive we are the less 
questions we get from the field, which saves us time and money.

We have used this approach for over 16 years and have not had any problems or 
holdups, so far.

The Other Brian



-Original Message-
From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Helge Knudsen
Sent: Sunday, November 18, 2012 9:22 AM
To: 'Carpentier Kristiaan'; 'Nick Williams'; EMC-PSTC@LISTSERV.IEEE.ORG
Subject: RE: EU-DoC - list of applied standards with full title

Hello Kris,

About 10 years ago my company Niros Telecommunication was contacted by the 
Belgium Authority whom told that the DoC should be written in Dutch as well as 
in French and German.

At that time we had a DoC written in English, German, French and Italian.

We changed to a combination of a short form DoC and one complete DoC written in 
English.

Short form in English:
Hereby, [Name of manufacturer], declares that this [type of equipment] is in 
compliance with the essential requirements and other relevant provisions of 
Directive 1999/5/EC.

The short form DoC can be found at the link below:

http://ec.europa.eu/enterprise/sectors/rtte/documents/interpretation/index_e
n.htm
See 23. Form of the manufacturers' declaration to be put into the user's 
manual

We used this form for DoC for the ATEX directive as well.

Best regards

Helge Knudsen

Former Test  Approval manager
Niros Telecommunication
Denmark


-Original Message-
From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Carpentier 
Kristiaan
Sent: 18. november 2012 14:13
To: Nick Williams; EMC-PSTC@LISTSERV.IEEE.ORG
Subject: RE: EU-DoC - list of applied standards with full title

Nick,

My country, Belgium, has 3 official national languages, Dutch, French and 
German. The most recent draft of the Belgian transposition proposal of the RoHS 
Directive states now that the EU DoC should be drawn up in a language easily 
understandable by authorities. While the authorities have the right to request 
a translation in one of the official languages, it allows the use of English. 
Hopefull other countries follow that example as it worked well for  20 years.

Best regards,
Kris Carpentier

-Original Message-
From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Nick Williams
Sent: zondag 18 november 2012 11:14
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: EU-DoC - list of applied standards with full title

It's actually a requirement of some of the directives, not just an addition 
brought in by transposition in certain countries. Generally, where the 
Directive requires the Declaration to accompany the product, it must be 
translated in to the language of the country of the end user.

I guess the Commissiion's logic is that the instructions will need to be 
translated into the same language(s) so it's not a significant additional 
burden to require the DofC to be translated as well.

Nick.



On 18 Nov 2012, at 07:56, John Woodgate j...@jmwa.demon.co.uk wrote:

 In message
867f4b6a1672e541a94676d556793acd1b66ce1...@mopesmbx01.eu.thmulti.com,
dated Sat, 17 Nov 2012, Carpentier Kristiaan 
kristiaan.carpent...@technicolor.com writes:

 Some countries require in their national transposition that the EU
 DoC is
issued in the local language. Although most are still in draft: France in 
French, Portugal in Portuguese, Germany in German,  etc..

 In worst case, we have some 24 languages in EU, so lots of fun for
translation.

 Now that IS a hardship for manufacturers. The way to deal with it is
 for
manufacturers' associations to petition the Commission for a clarification of 
the 'reference' requirement to mean just EN X:

-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 
emc-p...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online

Re: [PSES] EU-DoC - list of applied standards with full title

2012-11-19 Thread McInturff, Gary
I'm also just curious what countries don't use Arabic numerals? I would have 
been able to understand what standard was in play from what you sent below if 
you had sent it in Dutch, or Spanish. Group and class
Groep 1, klasse A and Grupo 1, clase A, took about 30 seconds to actually 
translate and I suspect that I can remember them the next time I see them in 
this form. 
Requiring the name in the local language is killing a fly with a sledgehammer. 
Gary


-Original Message-
From: Kunde, Brian [mailto:brian_ku...@lecotc.com] 
Sent: Monday, November 19, 2012 6:10 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] EU-DoC - list of applied standards with full title

I think this all begs the question, has anyone experienced any problems with 
their EU DOC by not providing the Standard's Title? If so, what was the 
objection and what was necessary to resolve it?

The official titles of directives and standards are often way too long and 
often more confusing then descriptive.

We reference directives and standards on our EU DOC by their number and date 
and follow it with a brief description and sometimes additional useful 
information. Such as:

EN 61010-1:2010   Safety of Laboratory Equipment

Or

EN55011:2007+A2:2007RF EmissionsGroup 1, Class A


The directives requirements are, a reference to the harmonized standards 
used, so I would think as long as you provide enough information so it is 
clear what the standards are you should be ok.

We think about what information our customers and others might want to see in 
the DOC and include it if we can. The more descriptive we are the less 
questions we get from the field, which saves us time and money.

We have used this approach for over 16 years and have not had any problems or 
holdups, so far.

The Other Brian



-Original Message-
From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Helge Knudsen
Sent: Sunday, November 18, 2012 9:22 AM
To: 'Carpentier Kristiaan'; 'Nick Williams'; EMC-PSTC@LISTSERV.IEEE.ORG
Subject: RE: EU-DoC - list of applied standards with full title

Hello Kris,

About 10 years ago my company Niros Telecommunication was contacted by the 
Belgium Authority whom told that the DoC should be written in Dutch as well as 
in French and German.

At that time we had a DoC written in English, German, French and Italian.

We changed to a combination of a short form DoC and one complete DoC written in 
English.

Short form in English:
Hereby, [Name of manufacturer], declares that this [type of equipment] is in 
compliance with the essential requirements and other relevant provisions of 
Directive 1999/5/EC.

The short form DoC can be found at the link below:

http://ec.europa.eu/enterprise/sectors/rtte/documents/interpretation/index_e
n.htm
See 23. Form of the manufacturers' declaration to be put into the user's 
manual

We used this form for DoC for the ATEX directive as well.

Best regards

Helge Knudsen

Former Test  Approval manager
Niros Telecommunication
Denmark


-Original Message-
From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Carpentier 
Kristiaan
Sent: 18. november 2012 14:13
To: Nick Williams; EMC-PSTC@LISTSERV.IEEE.ORG
Subject: RE: EU-DoC - list of applied standards with full title

Nick,

My country, Belgium, has 3 official national languages, Dutch, French and 
German. The most recent draft of the Belgian transposition proposal of the RoHS 
Directive states now that the EU DoC should be drawn up in a language easily 
understandable by authorities. While the authorities have the right to request 
a translation in one of the official languages, it allows the use of English. 
Hopefull other countries follow that example as it worked well for  20 years.

Best regards,
Kris Carpentier

-Original Message-
From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Nick Williams
Sent: zondag 18 november 2012 11:14
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: EU-DoC - list of applied standards with full title

It's actually a requirement of some of the directives, not just an addition 
brought in by transposition in certain countries. Generally, where the 
Directive requires the Declaration to accompany the product, it must be 
translated in to the language of the country of the end user.

I guess the Commissiion's logic is that the instructions will need to be 
translated into the same language(s) so it's not a significant additional 
burden to require the DofC to be translated as well.

Nick.



On 18 Nov 2012, at 07:56, John Woodgate j...@jmwa.demon.co.uk wrote:

 In message
867f4b6a1672e541a94676d556793acd1b66ce1...@mopesmbx01.eu.thmulti.com,
dated Sat, 17 Nov 2012, Carpentier Kristiaan 
kristiaan.carpent...@technicolor.com writes:

 Some countries require in their national transposition that the EU
 DoC is
issued in the local language. Although most are still in draft: France in 
French, Portugal in Portuguese, Germany in German,  etc

Re: [PSES] EU-DoC - list of applied standards with full title

2012-11-19 Thread Steven Brody
In the realm of industrial use products on the DoC or Do we had the number
and name of the standard(s) that were used to confirm conformance to the
Directive.  While market surveillance was never a problem for us, and
customs in one EU Member State only questioned our product once, and that
due to their misinterpretation of the product type, we found that more often
it was the customer who asked what the standards were when we only used the
number.  The question usually came from someone in Purchasing or Quality
when they got their copy of the DoC or DoI when the product arrived on their
doorstep. 

From then on it was decided to use name in conjunction with the number.  And
since we had templates for the DoC or DoI and only changed the variables
(serial number, date, DoC or DoI document number, etc.) it was not a
problem. 

Steve Brody
sgbr...@comcast.net
stev...@productehsconsultng.com
www.ProductEHSConsulting.com 


-Original Message-
From: Kunde, Brian [mailto:brian_ku...@lecotc.com] 
Sent: Monday, November 19, 2012 9:10 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] EU-DoC - list of applied standards with full title

I think this all begs the question, has anyone experienced any problems with
their EU DOC by not providing the Standard's Title? If so, what was the
objection and what was necessary to resolve it?

The official titles of directives and standards are often way too long and
often more confusing then descriptive.

We reference directives and standards on our EU DOC by their number and date
and follow it with a brief description and sometimes additional useful
information. Such as:

EN 61010-1:2010   Safety of Laboratory Equipment

Or

EN55011:2007+A2:2007RF EmissionsGroup 1, Class A


The directives requirements are, a reference to the harmonized standards
used, so I would think as long as you provide enough information so it is
clear what the standards are you should be ok.

We think about what information our customers and others might want to see
in the DOC and include it if we can. The more descriptive we are the less
questions we get from the field, which saves us time and money.

We have used this approach for over 16 years and have not had any problems
or holdups, so far.

The Other Brian



-Original Message-
From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Helge
Knudsen
Sent: Sunday, November 18, 2012 9:22 AM
To: 'Carpentier Kristiaan'; 'Nick Williams'; EMC-PSTC@LISTSERV.IEEE.ORG
Subject: RE: EU-DoC - list of applied standards with full title

Hello Kris,

About 10 years ago my company Niros Telecommunication was contacted by the
Belgium Authority whom told that the DoC should be written in Dutch as well
as in French and German.

At that time we had a DoC written in English, German, French and Italian.

We changed to a combination of a short form DoC and one complete DoC written
in English.

Short form in English:
Hereby, [Name of manufacturer], declares that this [type of equipment] is in
compliance with the essential requirements and other relevant provisions of
Directive 1999/5/EC.

The short form DoC can be found at the link below:

http://ec.europa.eu/enterprise/sectors/rtte/documents/interpretation/index_e
n.htm
See 23. Form of the manufacturers' declaration to be put into the user's
manual

We used this form for DoC for the ATEX directive as well.

Best regards

Helge Knudsen

Former Test  Approval manager
Niros Telecommunication
Denmark


-Original Message-
From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Carpentier
Kristiaan
Sent: 18. november 2012 14:13
To: Nick Williams; EMC-PSTC@LISTSERV.IEEE.ORG
Subject: RE: EU-DoC - list of applied standards with full title

Nick,

My country, Belgium, has 3 official national languages, Dutch, French and
German. The most recent draft of the Belgian transposition proposal of the
RoHS Directive states now that the EU DoC should be drawn up in a language
easily understandable by authorities. While the authorities have the right
to request a translation in one of the official languages, it allows the use
of English. Hopefull other countries follow that example as it worked well
for  20 years.

Best regards,
Kris Carpentier

-Original Message-
From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Nick
Williams
Sent: zondag 18 november 2012 11:14
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: EU-DoC - list of applied standards with full title

It's actually a requirement of some of the directives, not just an addition
brought in by transposition in certain countries. Generally, where the
Directive requires the Declaration to accompany the product, it must be
translated in to the language of the country of the end user.

I guess the Commissiion's logic is that the instructions will need to be
translated into the same language(s) so it's not a significant additional
burden to require the DofC to be translated as well.

Nick.



On 18 Nov 2012

Re: [PSES] EU-DoC - list of applied standards with full title

2012-11-19 Thread Ken Wyatt
While I was with HP and Agilent, we always listed the standard (as IEC/EN), 
the applicable annexes, the date of issue, an abbreviated title and the 
abbreviated test limits. Never had a problem, as far as I know.
___
Kenneth Wyatt
Wyatt Technical Services LLC
Woodland Park, CO
Email Me! | Web Site | Blog
The EMC Blog (TM World)
Subscribe to Newsletter
Connect with me on LinkedIn

On Nov 19, 2012, at 9:30 AM, McInturff, Gary wrote:

 I'm also just curious what countries don't use Arabic numerals? I would have 
 been able to understand what standard was in play from what you sent below if 
 you had sent it in Dutch, or Spanish. Group and class
 Groep 1, klasse A and Grupo 1, clase A, took about 30 seconds to actually 
 translate and I suspect that I can remember them the next time I see them in 
 this form. 
 Requiring the name in the local language is killing a fly with a 
 sledgehammer. 
 Gary
 
 
 -Original Message-
 From: Kunde, Brian [mailto:brian_ku...@lecotc.com] 
 Sent: Monday, November 19, 2012 6:10 AM
 To: EMC-PSTC@LISTSERV.IEEE.ORG
 Subject: Re: [PSES] EU-DoC - list of applied standards with full title
 
 I think this all begs the question, has anyone experienced any problems with 
 their EU DOC by not providing the Standard's Title? If so, what was the 
 objection and what was necessary to resolve it?
 
 The official titles of directives and standards are often way too long and 
 often more confusing then descriptive.
 
 We reference directives and standards on our EU DOC by their number and date 
 and follow it with a brief description and sometimes additional useful 
 information. Such as:
 
 EN 61010-1:2010   Safety of Laboratory Equipment
 
 Or
 
 EN55011:2007+A2:2007RF EmissionsGroup 1, Class A
 
 
 The directives requirements are, a reference to the harmonized standards 
 used, so I would think as long as you provide enough information so it is 
 clear what the standards are you should be ok.
 
 We think about what information our customers and others might want to see in 
 the DOC and include it if we can. The more descriptive we are the less 
 questions we get from the field, which saves us time and money.
 
 We have used this approach for over 16 years and have not had any problems or 
 holdups, so far.
 
 The Other Brian
 
 
 
 -Original Message-
 From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Helge Knudsen
 Sent: Sunday, November 18, 2012 9:22 AM
 To: 'Carpentier Kristiaan'; 'Nick Williams'; EMC-PSTC@LISTSERV.IEEE.ORG
 Subject: RE: EU-DoC - list of applied standards with full title
 
 Hello Kris,
 
 About 10 years ago my company Niros Telecommunication was contacted by the 
 Belgium Authority whom told that the DoC should be written in Dutch as well 
 as in French and German.
 
 At that time we had a DoC written in English, German, French and Italian.
 
 We changed to a combination of a short form DoC and one complete DoC written 
 in English.
 
 Short form in English:
 Hereby, [Name of manufacturer], declares that this [type of equipment] is in 
 compliance with the essential requirements and other relevant provisions of 
 Directive 1999/5/EC.
 
 The short form DoC can be found at the link below:
 
 http://ec.europa.eu/enterprise/sectors/rtte/documents/interpretation/index_e
 n.htm
 See 23. Form of the manufacturers' declaration to be put into the user's 
 manual
 
 We used this form for DoC for the ATEX directive as well.
 
 Best regards
 
 Helge Knudsen
 
 Former Test  Approval manager
 Niros Telecommunication
 Denmark
 
 
 -Original Message-
 From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Carpentier 
 Kristiaan
 Sent: 18. november 2012 14:13
 To: Nick Williams; EMC-PSTC@LISTSERV.IEEE.ORG
 Subject: RE: EU-DoC - list of applied standards with full title
 
 Nick,
 
 My country, Belgium, has 3 official national languages, Dutch, French and 
 German. The most recent draft of the Belgian transposition proposal of the 
 RoHS Directive states now that the EU DoC should be drawn up in a language 
 easily understandable by authorities. While the authorities have the right to 
 request a translation in one of the official languages, it allows the use of 
 English. Hopefull other countries follow that example as it worked well for  
 20 years.
 
 Best regards,
 Kris Carpentier
 
 -Original Message-
 From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Nick Williams
 Sent: zondag 18 november 2012 11:14
 To: EMC-PSTC@LISTSERV.IEEE.ORG
 Subject: Re: EU-DoC - list of applied standards with full title
 
 It's actually a requirement of some of the directives, not just an addition 
 brought in by transposition in certain countries. Generally, where the 
 Directive requires the Declaration to accompany the product, it must be 
 translated in to the language of the country of the end user.
 
 I guess the Commissiion's logic is that the instructions will need to be 
 translated

Re: [PSES] EU-DoC - list of applied standards with full title

2012-11-19 Thread Peter_Kelleher
In fact, the Note 3 at the bottom of the OJ listing itself provides a hint as 
to what is expected in referencing the standard:



Note 3: In case of amendments, the referenced standard is EN C:, its 
previous amendments, if any, and the new, quoted amendment...



While the Note is there to offer guidance on how to handle amendments, it seems 
reasonable to infer that the same format would apply to the base standard as 
well.



The important point is to make an unambiguous reference so that the reader of 
the DoC knows  exactly what standard you applied.



If the standard numbers and amendments are  listed along with their respective 
years of publication* on the DoC, that will constitute an unambiguous reference.

The title of the standard is not necessary (and may not even be helpful) to 
make an unambiguous reference.



So:



EN 60950-1:2006 + A11:2009 + A12:2011 is an unambiguous reference.



Examples of ambiguous references would be:

'EN 60950'

'EN 60950-1 +applicable amendments'



I have never seen a case where an authority challenged an unambiguous reference 
such as the above with or without the title of the standard listed.



Regards



Peter.





*One could probably argue that the year of the amendments is not necessary if 
the base standard is correctly identified. i.e. There will only ever by one 
'A11' to  EN 60950-1:2006 irrespective of what year it is published.









-Original Message-
From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Kunde, Brian
Sent: 19 November 2012 14:10
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: RE: EU-DoC - list of applied standards with full title



I think this all begs the question, has anyone experienced any problems with 
their EU DOC by not providing the Standard's Title? If so, what was the 
objection and what was necessary to resolve it?



The official titles of directives and standards are often way too long and 
often more confusing then descriptive.



We reference directives and standards on our EU DOC by their number and date 
and follow it with a brief description and sometimes additional useful 
information. Such as:



EN 61010-1:2010   Safety of Laboratory Equipment



Or



EN55011:2007+A2:2007RF EmissionsGroup 1, Class A





The directives requirements are, a reference to the harmonized standards 
used, so I would think as long as you provide enough information so it is 
clear what the standards are you should be ok.



We think about what information our customers and others might want to see in 
the DOC and include it if we can. The more descriptive we are the less 
questions we get from the field, which saves us time and money.



We have used this approach for over 16 years and have not had any problems or 
holdups, so far.



The Other Brian







-Original Message-

From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Helge Knudsen

Sent: Sunday, November 18, 2012 9:22 AM

To: 'Carpentier Kristiaan'; 'Nick Williams'; EMC-PSTC@LISTSERV.IEEE.ORG

Subject: RE: EU-DoC - list of applied standards with full title



Hello Kris,



About 10 years ago my company Niros Telecommunication was contacted by the 
Belgium Authority whom told that the DoC should be written in Dutch as well as 
in French and German.



At that time we had a DoC written in English, German, French and Italian.



We changed to a combination of a short form DoC and one complete DoC written in 
English.



Short form in English:

Hereby, [Name of manufacturer], declares that this [type of equipment] is in 
compliance with the essential requirements and other relevant provisions of 
Directive 1999/5/EC.



The short form DoC can be found at the link below:



http://ec.europa.eu/enterprise/sectors/rtte/documents/interpretation/index_e

n.htm

See 23. Form of the manufacturers' declaration to be put into the user's 
manual



We used this form for DoC for the ATEX directive as well.



Best regards



Helge Knudsen



Former Test  Approval manager

Niros Telecommunication

Denmark





-Original Message-

From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Carpentier 
Kristiaan

Sent: 18. november 2012 14:13

To: Nick Williams; EMC-PSTC@LISTSERV.IEEE.ORG

Subject: RE: EU-DoC - list of applied standards with full title



Nick,



My country, Belgium, has 3 official national languages, Dutch, French and 
German. The most recent draft of the Belgian transposition proposal of the RoHS 
Directive states now that the EU DoC should be drawn up in a language easily 
understandable by authorities. While the authorities have the right to request 
a translation in one of the official languages, it allows the use of English. 
Hopefull other countries follow that example as it worked well for  20 years.



Best regards,

Kris Carpentier



-Original Message-

From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Nick Williams

Sent: zondag 18 november 2012 11:14

Re: [PSES] EU-DoC - list of applied standards with full title

2012-11-19 Thread John Woodgate
In message 
d250d01e39356a4e9cc3b4b459d6655094d92...@ms-cda-01.advanced-input.com, 
dated Mon, 19 Nov 2012, McInturff, Gary gary.mcintu...@esterline.com 
writes:



I'm also just curious what countries don't use Arabic numerals?


Almost all countries that are not Arabic, in fact! 'Our' numerals are a 
corrupted version of true Arabic numerals.

--
OOO - Own Opinions Only. See www.jmwa.demon.co.uk
The longer it takes to make a point, the more obtuse it proves to be.
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK

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Re: [PSES] EU-DoC - list of applied standards with full title

2012-11-18 Thread John Woodgate
In message 
867f4b6a1672e541a94676d556793acd1b66ce1...@mopesmbx01.eu.thmulti.com, 
dated Sat, 17 Nov 2012, Carpentier Kristiaan 
kristiaan.carpent...@technicolor.com writes:


Some countries require in their national transposition that the EU DoC 
is issued in the local language. Although most are still in draft: 
France in French, Portugal in Portuguese, Germany in German,  etc..  


In worst case, we have some 24 languages in EU, so lots of fun for 
translation.


Now that IS a hardship for manufacturers. The way to deal with it is for 
manufacturers' associations to petition the Commission for a 
clarification of the 'reference' requirement to mean just EN X:

--
OOO - Own Opinions Only. See www.jmwa.demon.co.uk
The longer it takes to make a point, the more obtuse it proves to be.
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK

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Re: [PSES] EU-DoC - list of applied standards with full title

2012-11-18 Thread Nick Williams
It's actually a requirement of some of the directives, not just an addition 
brought in by transposition in certain countries. Generally, where the 
Directive requires the Declaration to accompany the product, it must be 
translated in to the language of the country of the end user. 

I guess the Commissiion's logic is that the instructions will need to be 
translated into the same language(s) so it's not a significant additional 
burden to require the DofC to be translated as well. 

Nick. 



On 18 Nov 2012, at 07:56, John Woodgate j...@jmwa.demon.co.uk wrote:

 In message 
 867f4b6a1672e541a94676d556793acd1b66ce1...@mopesmbx01.eu.thmulti.com, dated 
 Sat, 17 Nov 2012, Carpentier Kristiaan kristiaan.carpent...@technicolor.com 
 writes:
 
 Some countries require in their national transposition that the EU DoC is 
 issued in the local language. Although most are still in draft: France in 
 French, Portugal in Portuguese, Germany in German,  etc..  
 
 In worst case, we have some 24 languages in EU, so lots of fun for 
 translation.
 
 Now that IS a hardship for manufacturers. The way to deal with it is for 
 manufacturers' associations to petition the Commission for a clarification of 
 the 'reference' requirement to mean just EN X:

-

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Re: [PSES] EU-DoC - list of applied standards with full title

2012-11-18 Thread John Woodgate
In message b186fb02-da44-4d60-969a-ae6ee3015...@conformance.co.uk, 
dated Sun, 18 Nov 2012, Nick Williams nick.willi...@conformance.co.uk 
writes:


I guess the Commissiion's logic is that the instructions will need to 
be translated into the same language(s) so it's not a significant 
additional burden to require the DofC to be translated as well.


The titles of standards MUST NOT be translated, they must be the 
official titles in each language, and it may not be easy to find these.

--
OOO - Own Opinions Only. See www.jmwa.demon.co.uk
The longer it takes to make a point, the more obtuse it proves to be.
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK

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Re: [PSES] EU-DoC - list of applied standards with full title

2012-11-18 Thread Carpentier Kristiaan
Nick,

My country, Belgium, has 3 official national languages, Dutch, French and 
German. The most recent draft of the Belgian transposition proposal of the RoHS 
Directive states now that the EU DoC should be drawn up in a language easily 
understandable by authorities. While the authorities have the right to request 
a translation in one of the official languages, it allows the use of English. 
Hopefull other countries follow that example as it worked well for  20 years.

Best regards, 
Kris Carpentier

-Original Message-
From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Nick Williams
Sent: zondag 18 november 2012 11:14
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: EU-DoC - list of applied standards with full title

It's actually a requirement of some of the directives, not just an addition 
brought in by transposition in certain countries. Generally, where the 
Directive requires the Declaration to accompany the product, it must be 
translated in to the language of the country of the end user. 

I guess the Commissiion's logic is that the instructions will need to be 
translated into the same language(s) so it's not a significant additional 
burden to require the DofC to be translated as well. 

Nick. 



On 18 Nov 2012, at 07:56, John Woodgate j...@jmwa.demon.co.uk wrote:

 In message 
 867f4b6a1672e541a94676d556793acd1b66ce1...@mopesmbx01.eu.thmulti.com, dated 
 Sat, 17 Nov 2012, Carpentier Kristiaan kristiaan.carpent...@technicolor.com 
 writes:
 
 Some countries require in their national transposition that the EU DoC is 
 issued in the local language. Although most are still in draft: France in 
 French, Portugal in Portuguese, Germany in German,  etc..  
 
 In worst case, we have some 24 languages in EU, so lots of fun for 
 translation.
 
 Now that IS a hardship for manufacturers. The way to deal with it is for 
 manufacturers' associations to petition the Commission for a clarification of 
 the 'reference' requirement to mean just EN X:

-

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Re: [PSES] EU-DoC - list of applied standards with full title

2012-11-18 Thread Helge Knudsen
Hello Kris,

About 10 years ago my company Niros Telecommunication was contacted by the
Belgium Authority whom told that the DoC should be written in Dutch as well
as in French and German.

At that time we had a DoC written in English, German, French and Italian.

We changed to a combination of a short form DoC and one complete DoC written
in English.  

Short form in English:
Hereby, [Name of manufacturer], declares that this [type of equipment] is in
compliance with the essential requirements and other relevant provisions of
Directive 1999/5/EC.

The short form DoC can be found at the link below:

http://ec.europa.eu/enterprise/sectors/rtte/documents/interpretation/index_e
n.htm
See 23. Form of the manufacturers' declaration to be put into the user's
manual

We used this form for DoC for the ATEX directive as well.

Best regards

Helge Knudsen

Former Test  Approval manager
Niros Telecommunication
Denmark


-Original Message-
From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Carpentier
Kristiaan
Sent: 18. november 2012 14:13
To: Nick Williams; EMC-PSTC@LISTSERV.IEEE.ORG
Subject: RE: EU-DoC - list of applied standards with full title

Nick,

My country, Belgium, has 3 official national languages, Dutch, French and
German. The most recent draft of the Belgian transposition proposal of the
RoHS Directive states now that the EU DoC should be drawn up in a language
easily understandable by authorities. While the authorities have the right
to request a translation in one of the official languages, it allows the use
of English. Hopefull other countries follow that example as it worked well
for  20 years.

Best regards, 
Kris Carpentier

-Original Message-
From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Nick
Williams
Sent: zondag 18 november 2012 11:14
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: EU-DoC - list of applied standards with full title

It's actually a requirement of some of the directives, not just an addition
brought in by transposition in certain countries. Generally, where the
Directive requires the Declaration to accompany the product, it must be
translated in to the language of the country of the end user. 

I guess the Commissiion's logic is that the instructions will need to be
translated into the same language(s) so it's not a significant additional
burden to require the DofC to be translated as well. 

Nick. 



On 18 Nov 2012, at 07:56, John Woodgate j...@jmwa.demon.co.uk wrote:

 In message
867f4b6a1672e541a94676d556793acd1b66ce1...@mopesmbx01.eu.thmulti.com,
dated Sat, 17 Nov 2012, Carpentier Kristiaan
kristiaan.carpent...@technicolor.com writes:
 
 Some countries require in their national transposition that the EU DoC is
issued in the local language. Although most are still in draft: France in
French, Portugal in Portuguese, Germany in German,  etc..  
 
 In worst case, we have some 24 languages in EU, so lots of fun for
translation.
 
 Now that IS a hardship for manufacturers. The way to deal with it is for
manufacturers' associations to petition the Commission for a clarification
of the 'reference' requirement to mean just EN X:

-

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[PSES] EU-DoC - list of applied standards with full title

2012-11-17 Thread Michael Loerzer
Hello,

 

I have my personal opion but different experiences with market surveillance
authorities with respect to the following question:

 

Decision 768/2008/EC (Annex III) or all existing new approach directives
specifies the content of an EU-DoC as follows.

 

References to the relevant harmonised standards used or references to the
specifications in relation to which conformity is declared

 

What does “references” mean?

 

· EN :year/month AND

· the title?

 

ISO/IEC 17050-1 requires the title but a standard is not a legal
requirement.

 

Best regards

 

Dipl.-Ing. Michael Loerzer

Managing Director
Regulatory Affairs Specialist

 

Globalnorm GmbH

Kurfürstenstr. 112

10787 Berlin

 

Phone +49 30 3229027-51

Cell +49 170 3229027

Fax +49 30 3229027-59

Mail mailto:michael.loer...@globalnorm.de
michael.loer...@globalnorm.de

 

 http://www.globalnorm.de/ » globalnorm.de

 

Globalnorm GmbH, Sitz der Gesellschaft: Kurfürstenstr. 112, 10787 Berlin

Geschäftsführer: Dipl.-Ing. Michael Loerzer

Amtsgericht Berlin-Charlottenburg HRB 105204 B, USt-ID-Nummer: DE251654448

 


-

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Re: [PSES] EU-DoC - list of applied standards with full title

2012-11-17 Thread John Woodgate
In message 001901cdc4ff$a4da0ab0$ee8e2010$@globalnorm.de, dated Sat, 
17 Nov 2012, Michael Loerzer loerzer_mob...@globalnorm.de writes:


I have my personal opion but different experiences with market 
surveillance authorities with respect to the following question:


Is there any difficulty in including the title? If not, it is better not 
to risk an objection by not including it.

--
OOO - Own Opinions Only. See www.jmwa.demon.co.uk
The longer it takes to make a point, the more obtuse it proves to be.
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK

-

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[PSES] AW: EU-DoC - list of applied standards with full title

2012-11-17 Thread Michael Loerzer
Comments from some manufacturers: too  much work (costs time and money)...
 
I also RECOMMEND to state the whole reference including the title but some
of my customers (managing directors...) ask me: is that LEGAL required?
 
Best regards
 
Dipl.-Ing. Michael Loerzer
Managing Director
Regulatory Affairs Specialist

Globalnorm GmbH
Kurfürstenstr. 112
10787 Berlin
 
Phone +49 30 3229027-51
Cell +49 170 3229027
Fax +49 30 3229027-59
Mailmichael.loer...@globalnorm.de

» globalnorm.de
 
Globalnorm GmbH, Sitz der Gesellschaft: Kurfürstenstr. 112, 10787 Berlin
Geschäftsführer: Dipl.-Ing. Michael Loerzer
Amtsgericht Berlin-Charlottenburg HRB 105204 B, USt-ID-Nummer: DE251654448


-Ursprüngliche Nachricht-
Von: emc-p...@ieee.org [mailto:emc-p...@ieee.org] Im Auftrag von John
Woodgate
Gesendet: Samstag, 17. November 2012 22:03
An: EMC-PSTC@LISTSERV.IEEE.ORG
Betreff: Re: EU-DoC - list of applied standards with full title

In message 001901cdc4ff$a4da0ab0$ee8e2010$@globalnorm.de, dated Sat,
17 Nov 2012, Michael Loerzer loerzer_mob...@globalnorm.de writes:

I have my personal opion but different experiences with market 
surveillance authorities with respect to the following question:

Is there any difficulty in including the title? If not, it is better not to
risk an objection by not including it.
--
OOO - Own Opinions Only. See www.jmwa.demon.co.uk The longer it takes to
make a point, the more obtuse it proves to be.
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK

-

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Re: [PSES] AW: EU-DoC - list of applied standards with full title

2012-11-17 Thread John Woodgate
In message 002201cdc508$a3e81a80$ebb84f80$@globalnorm.de, dated Sat, 
17 Nov 2012, Michael Loerzer loerzer_mob...@globalnorm.de writes:


Comments from some manufacturers: too  much work (costs time and 
money)...


They are just being stupid. The cost and time are utterly trivial. How 
much more time and money does a rejection of the DoC and the impounding 
of the shipment cost?

 
I also RECOMMEND to state the whole reference including the title but 
some of my customers (managing directors...) ask me: is that LEGAL 
required?


What you are asking for is the legal interpretation of the word 
'references'. Ask 10 lawyers and you will get 10 different opinions, 
none definitive and all very costly. Until the meaning is tested in a 
court (or maybe a succession of appeal courts), no-one knows for 
certain.

--
OOO - Own Opinions Only. See www.jmwa.demon.co.uk
The longer it takes to make a point, the more obtuse it proves to be.
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK

-

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[PSES] AW: AW: EU-DoC - list of applied standards with full title

2012-11-17 Thread Michael Loerzer
I agree.
 
Dipl.-Ing. Michael Loerzer
Managing Director
Regulatory Affairs Specialist

Globalnorm GmbH
Kurfürstenstr. 112
10787 Berlin
 
Phone +49 30 3229027-51
Cell +49 170 3229027
Fax +49 30 3229027-59
Mailmichael.loer...@globalnorm.de

» globalnorm.de
 
Globalnorm GmbH, Sitz der Gesellschaft: Kurfürstenstr. 112, 10787 Berlin
Geschäftsführer: Dipl.-Ing. Michael Loerzer
Amtsgericht Berlin-Charlottenburg HRB 105204 B, USt-ID-Nummer: DE251654448


-Ursprüngliche Nachricht-
Von: emc-p...@ieee.org [mailto:emc-p...@ieee.org] Im Auftrag von John
Woodgate
Gesendet: Samstag, 17. November 2012 22:41
An: EMC-PSTC@LISTSERV.IEEE.ORG
Betreff: Re: AW: EU-DoC - list of applied standards with full title

In message 002201cdc508$a3e81a80$ebb84f80$@globalnorm.de, dated Sat,
17 Nov 2012, Michael Loerzer loerzer_mob...@globalnorm.de writes:

Comments from some manufacturers: too  much work (costs time and 
money)...

They are just being stupid. The cost and time are utterly trivial. How much
more time and money does a rejection of the DoC and the impounding of the
shipment cost?
 
I also RECOMMEND to state the whole reference including the title but 
some of my customers (managing directors...) ask me: is that LEGAL 
required?

What you are asking for is the legal interpretation of the word
'references'. Ask 10 lawyers and you will get 10 different opinions, none
definitive and all very costly. Until the meaning is tested in a court (or
maybe a succession of appeal courts), no-one knows for certain.
--
OOO - Own Opinions Only. See www.jmwa.demon.co.uk The longer it takes to
make a point, the more obtuse it proves to be.
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK

-

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Re: [PSES] AW: EU-DoC - list of applied standards with full title

2012-11-17 Thread ce-test, qualified testing bv - Gert Gremmen
If the title and number were not linked together one-on-one,
Yes, I would suggest adding the title. But as they are linked, I do not see the 
need !
or
There cannot bany standard be mistaken for another by referencing number and 
year.
Or 
Adding the title would not resolve the disambiguity caused by the national 
standardization bodies 
in adapting the year's reference of a standard to the year of local 
publication. 

Gert Gremmen
Ce-test 
Owner LinkedIN EMC-experts group

-Oorspronkelijk bericht-
Van: emc-p...@ieee.org [mailto:emc-p...@ieee.org] Namens Michael Loerzer
Verzonden: zaterdag 17 november 2012 22:54
Aan: 'John Woodgate'; EMC-PSTC@LISTSERV.IEEE.ORG
Onderwerp: AW: AW: EU-DoC - list of applied standards with full title

I agree.
 
Dipl.-Ing. Michael Loerzer
Managing Director
Regulatory Affairs Specialist

Globalnorm GmbH
Kurfürstenstr. 112
10787 Berlin
 
Phone +49 30 3229027-51
Cell +49 170 3229027
Fax +49 30 3229027-59
Mailmichael.loer...@globalnorm.de

» globalnorm.de
 
Globalnorm GmbH, Sitz der Gesellschaft: Kurfürstenstr. 112, 10787 Berlin
Geschäftsführer: Dipl.-Ing. Michael Loerzer
Amtsgericht Berlin-Charlottenburg HRB 105204 B, USt-ID-Nummer: DE251654448


-Ursprüngliche Nachricht-
Von: emc-p...@ieee.org [mailto:emc-p...@ieee.org] Im Auftrag von John
Woodgate
Gesendet: Samstag, 17. November 2012 22:41
An: EMC-PSTC@LISTSERV.IEEE.ORG
Betreff: Re: AW: EU-DoC - list of applied standards with full title

In message 002201cdc508$a3e81a80$ebb84f80$@globalnorm.de, dated Sat,
17 Nov 2012, Michael Loerzer loerzer_mob...@globalnorm.de writes:

Comments from some manufacturers: too  much work (costs time and 
money)...

They are just being stupid. The cost and time are utterly trivial. How much
more time and money does a rejection of the DoC and the impounding of the
shipment cost?
 
I also RECOMMEND to state the whole reference including the title but 
some of my customers (managing directors...) ask me: is that LEGAL 
required?

What you are asking for is the legal interpretation of the word
'references'. Ask 10 lawyers and you will get 10 different opinions, none
definitive and all very costly. Until the meaning is tested in a court (or
maybe a succession of appeal courts), no-one knows for certain.
--
OOO - Own Opinions Only. See www.jmwa.demon.co.uk The longer it takes to
make a point, the more obtuse it proves to be.
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK

-

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Attachments are not permitted but the IEEE PSES Online Communities site at
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Website:  http://www.ieee-pses.org/
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David Heald: dhe...@gmail.com

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For help, send mail to the list administrators:
Scott Douglas emcp

Re: [PSES] EU-DoC - list of applied standards with full title

2012-11-17 Thread Carpentier Kristiaan
Michael,

You may also know that the RoHS Recast Directive 2011/65/EU is the first 
Directive using the NLF, coming into force in Jan. 2013.
Some countries require in their national transposition that the EU DoC is 
issued in the local language. Although most are still in draft: France in 
French, Portugal in Portuguese, Germany in German,  etc.
In worst case, we have some 24 languages in EU, so lots of fun for translation. 
One good point: ETSI has all titles of its standards translated online, see 
last pages of each standard.

Best regards,
Kris Carpentier

From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Michael Loerzer
Sent: zaterdag 17 november 2012 21:11
To: IEEE PSES
Subject: EU-DoC - list of applied standards with full title

Hello,

I have my personal opion but different experiences with market surveillance 
authorities with respect to the following question:

Decision 768/2008/EC (Annex III) or all existing new approach directives 
specifies the content of an EU-DoC as follows.

References to the relevant harmonised standards used or references to the 
specifications in relation to which conformity is declared

What does references mean?


· EN :year/month AND

· the title?

ISO/IEC 17050-1 requires the title but a standard is not a legal requirement.

Best regards

Dipl.-Ing. Michael Loerzer
Managing Director
Regulatory Affairs Specialist

Globalnorm GmbH
Kurfürstenstr. 112
10787 Berlin

Phone +49 30 3229027-51
Cell +49 170 3229027
Fax +49 30 3229027-59
Mailmichael.loer...@globalnorm.demailto:michael.loer...@globalnorm.de

» globalnorm.dehttp://www.globalnorm.de/

Globalnorm GmbH, Sitz der Gesellschaft: Kurfürstenstr. 112, 10787 Berlin
Geschäftsführer: Dipl.-Ing. Michael Loerzer
Amtsgericht Berlin-Charlottenburg HRB 105204 B, USt-ID-Nummer: DE251654448

-


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Re: [PSES] AW: EU-DoC - list of applied standards with full title

2012-11-17 Thread John Woodgate
In message FCA549BE3ECF9D4CB8CB8576837EA489140B07@ZEUS.cetest.local, 
dated Sat, 17 Nov 2012, ce-test, qualified testing bv - Gert Gremmen 
g.grem...@cetest.nl writes:


If the title and number were not linked together one-on-one, Yes, I 
would suggest adding the title. But as they are linked, I do not see 
the need !


The number might be incorrectly printed, e.g. EN 60056 instead of EN 
60065 (I have actually seen this). But the real reason for adding the 
title is that some people can make big trouble if it isn't added, 
whether they should or not.


or There cannot bany standard be mistaken for another by referencing 
number and year.
Or Adding the title would not resolve the disambiguity caused by the 
national standardization bodies in adapting the year's reference of a 
standard to the year of local publication.


The standard should be cited as 'EN X:', not as 'DIN EN' or 'BS 
EN'.

--
OOO - Own Opinions Only. See www.jmwa.demon.co.uk
The longer it takes to make a point, the more obtuse it proves to be.
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK

-

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RE: [PSES] Updating EU DoC

2010-10-12 Thread emc-p...@ieee.org
This seems to have become unnecessarily complicated.

 

If a standard changes, and you do some new testing or evaluation, then
updating the D of C to reflect that is quite sensible.  Your TF will show the
new work done to support it.

If a standard changes, and you have a quick look at the differences and decide
that it is unimportant (as plenty of amendments are) and there’s nothing you
need to do, then there’s no technical reason to amend the D of C.  Yes, the
presumption of conformity may have gone by not referencing the change, but
since you’ve concluded that the actual conformity isn’t affected, then
there’s no risk of any enforcement action succeeding.  It’s making work to
update every D of C to track every standards change, as you’ll also have to
put a justification in the TF.

You might want a nice new D of C to keep your customers happy, but that’s a
marketing matter, not one that you must follow.

 

John

 



From: Robert Heller [mailto:rehel...@mmm.com] 
Sent: 12 October 2010 10:32
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] Updating EU DoC

 

Bear in mind that under the latest EMC Directive, the DoC must contain dated
references (i.e., the standards tested to and their dates)(see note). If the
dates of the standards change then the DoC must be updated.

Note: Reference Directive 2004/108/EC, Annex IV, paragraph 2, fourth item.

Bob Heller
3M EMC Laboratory, 76-1-01
St. Paul, MN 55107-1208
Tel: 651- 778-6336
Fax: 651-778-6252
=

emc-p...@ieee.org wrote on 10/11/2010 12:49:27 PM:

 From:
 
 Kunde, Brian brian_ku...@lecotc.com
 
 To:
 
 emc-p...@ieee.org
 
 Date:
 
 10/11/2010 12:51 PM
 
 Subject:
 
 RE: Updating EU DoC
 
 Sent by:
 
 emc-p...@ieee.org
 
 Power is control and control is power and once someone has the power
 it is difficult for them to give it up.
  
 I fought like crazy to not have our DOCs controlled through our 
 Documentation Control department to avoid many of the problems you 
 are having. They have to be control somehow but I keep track of them
 within our Compliance Department. 
  
 How I was able to avoid ECN control of the DOC is on the DOC itself 
 I reworded the statement to say;
  
 “The product herewith displaying the CE marking complies with the 
 requirements of the……”
  
 So I argued that the CE compliance is not based on the DOC but on 
 the CE Marking which is ECN controlled.  The DOC just shows what the
 CE marking means at the time it was generated. 
  
 As far as the DOC generation, we keep the information on all 
 products in a database which includes the last audit date and other 
 information that would appear on the DOC. When we pull up a DOC for 
 any product, the DOC is dynamically generated with all the 
 appropriate dates and information. We just print/save it to a .pdf 
 file and store it in an archive area on our Intranet/network Page 
 where the Sales/Marketing and Manuals departments have READ access. 
 I’m the only one in the company with WRITE access to these folder so
 only I can change the DOCs. 
  
 We also archive all the old DOCs incase someone wants to pull a copy
 of an old version.
  
 I hope this was helpful.
  
 The Other Brian
  
 
 From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of 
 peterh...@aol.com
 Sent: Monday, October 11, 2010 11:38 AM
 To: emc-p...@ieee.org
 Subject: Updating EU DoC
  
  
 Hello group,
  
 I am looking to see how you folks generate and update your EU DOC. 
 We use the typical MS Word template and every time there is a need 
 for an update, we update this document and have to go through ECO 
 (Engineering Change Order) since it is a controlled document and I 
 found this process to be very time consuming and not really 
 efficient in particular when you have over 100 DOC's to maintain. Is
 there any easier way? Is there an automated process out there? Do we
 really need to have it under control revision?
  
 Thank you
 Peter
  
 -
 
 This message is from the IEEE Product Safety Engineering Society 
 emc-pstc discussion list. To post a message to the list, send your e-mail to

 emc-p...@ieee.org
 
 All emc-pstc postings are archived and searchable on the web at 
 http://www.ieeecommunities.org/emc-pstc
 Graphics (in well-used formats), large files, etc. can be posted to that
URL. 
 Website: http://www.ieee-pses.org/
 Instructions: http://listserv.ieee.org/request/user-guide.html
 List rules: http://www.ieee-pses.org/listrules.html 
 For help, send mail to the list administrators:
 Scott Douglas emcp...@radiusnorth.net
 Mike Cantwell mcantw...@ieee.org 
 For policy questions, send mail to:
 Jim Bacher j.bac...@ieee.org
 David Heald dhe...@gmail.com 
 _ 
 
 LECO Corporation Notice: This communication may contain confidential
 information intended for the named recipient(s) only. If you 
 received this by mistake, please destroy it and notify us

RE: [PSES] Updating EU DoC

2010-10-12 Thread emc-p...@ieee.org
I agree with this, but for completeness I would add that to the sentence that 
“the DoC must be updated if you want to maintain a ‘presumption of conformity’ 
with the EMC Directive.”

 

Strictly speaking the DoC does not have to be updated if there is some 
technical justification for not doing so.  But then the ‘presumption of 
conformity’ is lost, which is not the ideal situation to be in, so “the DoC 
ought to be updated” is another way of putting it.


Best Regards,

John

 

From: Robert Heller [mailto:rehel...@mmm.com] 
Sent: 12 October 2010 10:32
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] Updating EU DoC

 

Bear in mind that under the latest EMC Directive, the DoC must contain dated 
references (i.e., the standards tested to and their dates)(see note). If the 
dates of the standards change then the DoC must be updated.

Note: Reference Directive 2004/108/EC, Annex IV, paragraph 2, fourth item.

Bob Heller
3M EMC Laboratory, 76-1-01
St. Paul, MN 55107-1208
Tel: 651- 778-6336
Fax: 651-778-6252
=

emc-p...@ieee.org wrote on 10/11/2010 12:49:27 PM:

 From:
 
 Kunde, Brian brian_ku...@lecotc.com
 
 To:
 
 emc-p...@ieee.org
 
 Date:
 
 10/11/2010 12:51 PM
 
 Subject:
 
 RE: Updating EU DoC
 
 Sent by:
 
 emc-p...@ieee.org
 
 Power is control and control is power and once someone has the power
 it is difficult for them to give it up.
  
 I fought like crazy to not have our DOCs controlled through our 
 Documentation Control department to avoid many of the problems you 
 are having. They have to be control somehow but I keep track of them
 within our Compliance Department. 
  
 How I was able to avoid ECN control of the DOC is on the DOC itself 
 I reworded the statement to say;
  
 “The product herewith displaying the CE marking complies with the 
 requirements of the……”
  
 So I argued that the CE compliance is not based on the DOC but on 
 the CE Marking which is ECN controlled.  The DOC just shows what the
 CE marking means at the time it was generated. 
  
 As far as the DOC generation, we keep the information on all 
 products in a database which includes the last audit date and other 
 information that would appear on the DOC. When we pull up a DOC for 
 any product, the DOC is dynamically generated with all the 
 appropriate dates and information. We just print/save it to a .pdf 
 file and store it in an archive area on our Intranet/network Page 
 where the Sales/Marketing and Manuals departments have READ access. 
 I’m the only one in the company with WRITE access to these folder so
 only I can change the DOCs. 
  
 We also archive all the old DOCs incase someone wants to pull a copy
 of an old version.
  
 I hope this was helpful.
  
 The Other Brian
  
 
 From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of 
 peterh...@aol.com
 Sent: Monday, October 11, 2010 11:38 AM
 To: emc-p...@ieee.org
 Subject: Updating EU DoC
  
  
 Hello group,
  
 I am looking to see how you folks generate and update your EU DOC. 
 We use the typical MS Word template and every time there is a need 
 for an update, we update this document and have to go through ECO 
 (Engineering Change Order) since it is a controlled document and I 
 found this process to be very time consuming and not really 
 efficient in particular when you have over 100 DOC's to maintain. Is
 there any easier way? Is there an automated process out there? Do we
 really need to have it under control revision?
  
 Thank you
 Peter
  
 -
 
 This message is from the IEEE Product Safety Engineering Society 
 emc-pstc discussion list. To post a message to the list, send your e-mail to 
 emc-p...@ieee.org
 
 All emc-pstc postings are archived and searchable on the web at 
 http://www.ieeecommunities.org/emc-pstc
 Graphics (in well-used formats), large files, etc. can be posted to that URL. 
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 Instructions: http://listserv.ieee.org/request/user-guide.html
 List rules: http://www.ieee-pses.org/listrules.html 
 For help, send mail to the list administrators:
 Scott Douglas emcp...@radiusnorth.net
 Mike Cantwell mcantw...@ieee.org 
 For policy questions, send mail to:
 Jim Bacher j.bac...@ieee.org
 David Heald dhe...@gmail.com 
 _ 
 
 LECO Corporation Notice: This communication may contain confidential
 information intended for the named recipient(s) only. If you 
 received this by mistake, please destroy it and notify us of the 
 error. Thank you. 
 -
 
 This message is from the IEEE Product Safety Engineering Society 
 emc-pstc discussion list. To post a message to the list, send your e-mail to 
 emc-p...@ieee.org
 
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 Graphics (in well-used formats), large files, etc. can be posted to that URL. 
 Website: http://www.ieee

RE: Updating EU DoC

2010-10-12 Thread emc-p...@ieee.org
Bear in mind that under the latest EMC Directive, the DoC must contain dated 
references (i.e., the standards tested to and their dates)(see note). If the 
dates of the standards change then the DoC must be updated.

Note: Reference Directive 2004/108/EC, Annex IV, paragraph 2, fourth item.

Bob Heller
3M EMC Laboratory, 76-1-01
St. Paul, MN 55107-1208
Tel: 651- 778-6336
Fax: 651-778-6252
=

emc-p...@ieee.org wrote on 10/11/2010 12:49:27 PM:

 From:
 
 Kunde, Brian brian_ku...@lecotc.com
 
 To:
 
 emc-p...@ieee.org
 
 Date:
 
 10/11/2010 12:51 PM
 
 Subject:
 
 RE: Updating EU DoC
 
 Sent by:
 
 emc-p...@ieee.org
 
 Power is control and control is power and once someone has the power
 it is difficult for them to give it up.
  
 I fought like crazy to not have our DOCs controlled through our 
 Documentation Control department to avoid many of the problems you 
 are having. They have to be control somehow but I keep track of them
 within our Compliance Department. 
  
 How I was able to avoid ECN control of the DOC is on the DOC itself 
 I reworded the statement to say;
  
 “The product herewith displaying the CE marking complies with the 
 requirements of the……”
  
 So I argued that the CE compliance is not based on the DOC but on 
 the CE Marking which is ECN controlled.  The DOC just shows what the
 CE marking means at the time it was generated. 
  
 As far as the DOC generation, we keep the information on all 
 products in a database which includes the last audit date and other 
 information that would appear on the DOC. When we pull up a DOC for 
 any product, the DOC is dynamically generated with all the 
 appropriate dates and information. We just print/save it to a .pdf 
 file and store it in an archive area on our Intranet/network Page 
 where the Sales/Marketing and Manuals departments have READ access. 
 I’m the only one in the company with WRITE access to these folder so
 only I can change the DOCs. 
  
 We also archive all the old DOCs incase someone wants to pull a copy
 of an old version.
  
 I hope this was helpful.
  
 The Other Brian
  
 
 From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of 
 peterh...@aol.com
 Sent: Monday, October 11, 2010 11:38 AM
 To: emc-p...@ieee.org
 Subject: Updating EU DoC
  
  
 Hello group,
  
 I am looking to see how you folks generate and update your EU DOC. 
 We use the typical MS Word template and every time there is a need 
 for an update, we update this document and have to go through ECO 
 (Engineering Change Order) since it is a controlled document and I 
 found this process to be very time consuming and not really 
 efficient in particular when you have over 100 DOC's to maintain. Is
 there any easier way? Is there an automated process out there? Do we
 really need to have it under control revision?
  
 Thank you
 Peter
  
 -
 
 This message is from the IEEE Product Safety Engineering Society 
 emc-pstc discussion list. To post a message to the list, send your e-mail to 
 emc-p...@ieee.org
 
 All emc-pstc postings are archived and searchable on the web at 
 http://www.ieeecommunities.org/emc-pstc
 Graphics (in well-used formats), large files, etc. can be posted to that URL. 
 Website: http://www.ieee-pses.org/
 Instructions: http://listserv.ieee.org/request/user-guide.html
 List rules: http://www.ieee-pses.org/listrules.html 
 For help, send mail to the list administrators:
 Scott Douglas emcp...@radiusnorth.net
 Mike Cantwell mcantw...@ieee.org 
 For policy questions, send mail to:
 Jim Bacher j.bac...@ieee.org
 David Heald dhe...@gmail.com 
 _ 
 
 LECO Corporation Notice: This communication may contain confidential
 information intended for the named recipient(s) only. If you 
 received this by mistake, please destroy it and notify us of the 
 error. Thank you. 
 -
 
 This message is from the IEEE Product Safety Engineering Society 
 emc-pstc discussion list. To post a message to the list, send your e-mail to 
 emc-p...@ieee.org
 
 All emc-pstc postings are archived and searchable on the web at 
 http://www.ieeecommunities.org/emc-pstc
 Graphics (in well-used formats), large files, etc. can be posted to that URL. 
 Website: http://www.ieee-pses.org/
 Instructions: http://listserv.ieee.org/request/user-guide.html
 List rules: http://www.ieee-pses.org/listrules.html 
 For help, send mail to the list administrators:
 Scott Douglas emcp...@radiusnorth.net
 Mike Cantwell mcantw...@ieee.org 
 For policy questions, send mail to:
 Jim Bacher j.bac...@ieee.org
 David Heald dhe...@gmail.com 
-

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emc-p...@ieee.org

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AW: Updating EU DoC

2010-10-12 Thread emc-p...@ieee.org
Hello Peter,

 

for this issue we have developed the „DoC-Manager“ with an interface to our 
standards management software GLOBALNORM. If you are interested we can present 
this tool via a telephoe conference. I also attend the IEEE PSES symposium in 
Boston and we have a booth at the exhibition if you are going to Boston. 

 

Kind regards

 

Dipl.-Ing. Michael Loerzer

Managing Director
Regulatory Affairs Specialist

 

Das neue Buch zum Thema Product Compliance: 
http://www.beuth.de/sc/produktkonformitaet 
http://www.beuth.de/sc/produktkonformitaet  (Produktkonformität, Prozesse, 
Risikomanagement, CE-Kennzeichnung, Fallbeispiele für Geschäftsführung, 
Konstruktion, Normenabteilung, Vertrieb, Einkauf, Produktion, QM)

 

_

Globalnorm GmbH

Alt-Moabit 94

10559 Berlin

 

Fon +49 30 3229027-51

Mobile +49 170 3229027

Fax +49 30 3229027-59

Mailmichael.loer...@globalnorm.de 
mailto:michael.loer...@globalnorm.de 

 

www.globalnorm.de http://www.globalnorm.de/ 

www.globalnorm.ca http://www.globalnorm.ca/ 

www.product-compliance.com http://www.product-compliance.com/ 

 

_

Globalnorm GmbH, Sitz der Gesellschaft: Alt-Moabit 94, 10559 Berlin

Geschäftsführer: Dipl.-Ing. Michael Loerzer

Amtsgericht Berlin-Charlottenburg HRB 105204 B, USt-ID-Nummer: DE251654448

 

Von: emc-p...@ieee.org [mailto:emc-p...@ieee.org] Im Auftrag von 
peterh...@aol.com
Gesendet: Dienstag, 12. Oktober 2010 05:50
An: brian_ku...@lecotc.com; emc-p...@ieee.org
Betreff: Re: Updating EU DoC

 

Thank you all for your positive feedback.

 

The changes that we make is not component related, but it is mainly related to 
change in standards. For example, EN60950-1 1st edition to 2nd edition. So 
product itself has hardly changed but rather the Directive or standard has 
changed and therefore we need to reflect these in the new DoC. How would you 
handle such cases? 

 

Thanks

Peter

-Original Message-
From: Kunde, Brian brian_ku...@lecotc.com
To: emc-pstc emc-p...@ieee.org
Sent: Mon, Oct 11, 2010 10:51 am
Subject: RE: Updating EU DoC

Power is control and control is power and once someone has the power it is 
difficult for them to give it up.

 

I fought like crazy to not have our DOCs controlled through our Documentation 
Control department to avoid many of the problems you are having. They have to 
be control somehow but I keep track of them within our Compliance Department. 

 

How I was able to avoid ECN control of the DOC is on the DOC itself I reworded 
the statement to say;

 

“The product herewith displaying the CE marking complies with the requirements 
of the……”

 

So I argued that the CE compliance is not based on the DOC but on the CE 
Marking which is ECN controlled.  The DOC just shows what the CE marking means 
at the time it was generated. 

 

As far as the DOC generation, we keep the information on all products in a 
database which includes the last audit date and other information that would 
appear on the DOC. When we pull up a DOC for any product, the DOC is 
dynamically generated with all the appropriate dates and information. We just 
print/save it to a .pdf file and store it in an archive area on our 
Intranet/network Page where the Sales/Marketing and Manuals departments have 
READ access. I’m the only one in the company with WRITE access to these folder 
so only I can change the DOCs. 

 

We also archive all the old DOCs incase someone wants to pull a copy of an old 
version.

 

I hope this was helpful.

 

The Other Brian

 



From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of 
peterh...@aol.com
Sent: Monday, October 11, 2010 11:38 AM
To: emc-p...@ieee.org
Subject: Updating EU DoC

 

 

Hello group,

 

I am looking to see how you folks generate and update your EU DOC. We use the 
typical MS Word template and every time there is a need for an update, we 
update this document and have to go through ECO (Engineering Change Order) 
since it is a controlled document and I found this process to be very time 
consuming and not really efficient in particular when you have over 100 DOC's 
to maintain. Is there any easier way? Is there an automated process out there? 
Do we really need to have it under control revision?

 

Thank you

Peter

 

-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 
emc-p...@ieee.org

All emc-pstc postings are archived and searchable on the web at 
http://www.ieeecommunities.org/emc-pstc
Graphics (in well-used formats), large files, etc. can be posted to that URL. 

Website: http://www.ieee-pses.org/
Instructions: http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html 

For help, send mail to the list administrators

Re: Updating EU DoC

2010-10-12 Thread emc-p...@ieee.org
Thank you all for your positive feedback.
 
The changes that we make is not component related, but it is mainly related to 
change in standards. For example, EN60950-1 1st edition to 2nd edition. So 
product itself has hardly changed but rather the Directive or standard has 
changed and therefore we need to reflect these in the new DoC. How would you 
handle such cases? 
 
Thanks
Peter


-Original Message-
From: Kunde, Brian brian_ku...@lecotc.com
To: emc-pstc emc-p...@ieee.org
Sent: Mon, Oct 11, 2010 10:51 am
Subject: RE: Updating EU DoC


Power is control and control is power and once someone has the power it is 
difficult for them to give it up.
 
I fought like crazy to not have our DOCs controlled through our Documentation 
Control department to avoid many of the problems you are having. They have to 
be control somehow but I keep track of them within our Compliance Department. 
 
How I was able to avoid ECN control of the DOC is on the DOC itself I reworded 
the statement to say;
 
“The product herewith displaying the CE marking complies with the requirements 
of the……”
 
So I argued that the CE compliance is not based on the DOC but on the CE 
Marking which is ECN controlled.  The DOC just shows what the CE marking means 
at the time it was generated. 
 
As far as the DOC generation, we keep the information on all products in a 
database which includes the last audit date and other information that would 
appear on the DOC. When we pull up a DOC for any product, the DOC is 
dynamically generated with all the appropriate dates and information. We just 
print/save it to a .pdf file and store it in an archive area on our 
Intranet/network Page where the Sales/Marketing and Manuals departments have 
READ access. I’m the only one in the company with WRITE access to these folder 
so only I can change the DOCs. 
 
We also archive all the old DOCs incase someone wants to pull a copy of an old 
version.
 
I hope this was helpful.
 
The Other Brian
 


From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of 
peterh...@aol.com
Sent: Monday, October 11, 2010 11:38 AM
To: emc-p...@ieee.org
Subject: Updating EU DoC
 
 
Hello group,
 
I am looking to see how you folks generate and update your EU DOC. We use the 
typical MS Word template and every time there is a need for an update, we 
update this document and have to go through ECO (Engineering Change Order) 
since it is a controlled document and I found this process to be very time 
consuming and not really efficient in particular when you have over 100 DOC's 
to maintain. Is there any easier way? Is there an automated process out there? 
Do we really need to have it under control revision?
 
Thank you
Peter
 
-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 
emc-p...@ieee.org

All emc-pstc postings are archived and searchable on the web at 
http://www.ieeecommunities.org/emc-pstc
Graphics (in well-used formats), large files, etc. can be posted to that URL. 
Website: http://www.ieee-pses.org/
Instructions: http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html 
For help, send mail to the list administrators:
Scott Douglas emcp...@radiusnorth.net
Mike Cantwell mcantw...@ieee.org 
For policy questions, send mail to:
Jim Bacher j.bac...@ieee.org
David Heald dhe...@gmail.com 
_ 

LECO Corporation Notice: This communication may contain confidential 
information intended for the named recipient(s) only. If you received this by 
mistake, please destroy it and notify us of the error. Thank you. -

This message is from the IEEE Product Safety Engineering Society emc-pstc 
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LT;emc-p...@ieee.orgGT;

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Instructions: http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html 
For help, send mail to the list administrators:
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discussion list. To post a message to the list, send your e-mail to 
emc-p...@ieee.org

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Graphics (in well-used formats), large files, etc. can be posted to that URL

RE: Updating EU DoC

2010-10-11 Thread emc-p...@ieee.org
Power is control and control is power and once someone has the power it is
difficult for them to give it up.

 

I fought like crazy to not have our DOCs controlled through our Documentation
Control department to avoid many of the problems you are having. They have to
be control somehow but I keep track of them within our Compliance Department. 

 

How I was able to avoid ECN control of the DOC is on the DOC itself I reworded
the statement to say;

 

“The product herewith displaying the CE marking complies with the
requirements of the……”

 

So I argued that the CE compliance is not based on the DOC but on the CE
Marking which is ECN controlled.  The DOC just shows what the CE marking means
at the time it was generated. 

 

As far as the DOC generation, we keep the information on all products in a
database which includes the last audit date and other information that would
appear on the DOC. When we pull up a DOC for any product, the DOC is
dynamically generated with all the appropriate dates and information. We just
print/save it to a .pdf file and store it in an archive area on our
Intranet/network Page where the Sales/Marketing and Manuals departments have
READ access. I’m the only one in the company with WRITE access to these
folder so only I can change the DOCs. 

 

We also archive all the old DOCs incase someone wants to pull a copy of an old
version.

 

I hope this was helpful.

 

The Other Brian

 



From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of
peterh...@aol.com
Sent: Monday, October 11, 2010 11:38 AM
To: emc-p...@ieee.org
Subject: Updating EU DoC

 

 

Hello group,

 

I am looking to see how you folks generate and update your EU DOC. We use the
typical MS Word template and every time there is a need for an update, we
update this document and have to go through ECO (Engineering Change Order)
since it is a controlled document and I found this process to be very time
consuming and not really efficient in particular when you have over 100 DOC's
to maintain. Is there any easier way? Is there an automated process out there?
Do we really need to have it under control revision?

 

Thank you

Peter

 

-

This message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. To post a message to the list, send your e-mail to
emc-p...@ieee.org

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Graphics (in well-used formats), large files, etc. can be posted to that URL. 

Website: http://www.ieee-pses.org/
Instructions: http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html 

For help, send mail to the list administrators:
Scott Douglas emcp...@radiusnorth.net
Mike Cantwell mcantw...@ieee.org 

For policy questions, send mail to:
Jim Bacher j.bac...@ieee.org
David Heald dhe...@gmail.com 

_ 

LECO Corporation Notice: This communication may contain confidential
information intended for the named recipient(s) only. If you received this by
mistake, please destroy it and notify us of the error. Thank you. 
-

This message is from the IEEE Product Safety Engineering Society emc-pstc
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emc-p...@ieee.org

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Graphics (in well-used formats), large files, etc. can be posted to that URL. 

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Instructions: http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html 

For help, send mail to the list administrators:
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David Heald dhe...@gmail.com 




RE: [PSES] Updating EU DoC

2010-10-11 Thread emc-p...@ieee.org
Hello Peter,

 

You do not need to update your DoC for every ECO.  Your DoC is your
declaration to the outside world that you declare your particular product (or
several model variations of products) compliant with the EC Directive.  If you
make a component change (or any other reason for your ECO), yet your model
number remains the same as stated on your current DoC, then a new DoC is
certainly not required.  You would, of course, need to record the effect of
the ECO in your technical file, which backs up the DoC and this is where your
control should concentrate (i.e. your “internal production control” under
the 2004/108/EC).

 

My one-day EMC Goggles training course addresses such issues relating to the
EMC Directive, amongst many other aspects of EMC, including a clear
understanding of the effects of interference, design for compliance and EMC
testing.  It’s a complete all-round course with many tips included from my
20 years spent working in EMC.

 

I am giving this course at San Jose, California, on Monday 18th October –
that’s just next week!

 

If anyone is interested in attending, or knows of someone within their
organisation who needs to be brought up to speed on EMC, please email me
separately.  There are a few places available.

 

Best Regards,

John

 

From: peterh...@aol.com [mailto:peterh...@aol.com] 
Sent: 11 October 2010 16:38
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] Updating EU DoC

 

 

Hello group,

 

I am looking to see how you folks generate and update your EU DOC. We use the
typical MS Word template and every time there is a need for an update, we
update this document and have to go through ECO (Engineering Change Order)
since it is a controlled document and I found this process to be very time
consuming and not really efficient in particular when you have over 100 DOC's
to maintain. Is there any easier way? Is there an automated process out there?
Do we really need to have it under control revision?

 

Thank you

Peter

 

-

This message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. To post a message to the list, send your e-mail to
emc-p...@ieee.org

All emc-pstc postings are archived and searchable on the web at
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Graphics (in well-used formats), large files, etc. can be posted to that URL. 

Website: http://www.ieee-pses.org/
Instructions: http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html 

For help, send mail to the list administrators:
Scott Douglas emcp...@radiusnorth.net
Mike Cantwell mcantw...@ieee.org 

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Jim Bacher j.bac...@ieee.org
David Heald dhe...@gmail.com 


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David Heald dhe...@gmail.com 




Updating EU DoC

2010-10-11 Thread emc-p...@ieee.org


Hello group,
 
I am looking to see how you folks generate and update your EU DOC. We use the
typical MS Word template and every time there is a need for an update, we
update this document and have to go through ECO (Engineering Change Order)
since it is a controlled document and I found this process to be very time
consuming and not really efficient in particular when you have over 100 DOC's
to maintain. Is there any easier way? Is there an automated process out there?
Do we really need to have it under control revision?
 
Thank you
Peter



-

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discussion list. To post a message to the list, send your e-mail to
emc-p...@ieee.org

All emc-pstc postings are archived and searchable on the web at
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Graphics (in well-used formats), large files, etc. can be posted to that URL. 

Website: http://www.ieee-pses.org/
Instructions: http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html 

For help, send mail to the list administrators:
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Antwort: EU DoC on 2.4GHz TX Modules

2008-06-09 Thread mlehmann

Grace, 

you need to use the RTTE Directive where LVD and EMCD are included. 
For RTTE see radio standards. 

Kind regards 
Mario Lehmann 
  
Geschäftsbereich European Compliance Laboratory (ECL) 
__ 
HERBERG.
Service Plus GmbH   Tel:+49 911 59835-923 
Nordostpark 51  Fax:+49 911 59835-90 
90411 Nürnberg  mailto: mlehm...@herberg-sp.de
mailto:mlehm...@herberg-sp.de  
http://www.herberg-sp.de http://www.herberg-sp.de/  



Amtsgericht NürnbergGeschäftsführer   
HRB 19587   Peter Birkmann   





Grace Lin graceli...@gmail.com 
Gesendet von: emc-p...@ieee.org 

20.05.2008 17:44 An
emc-p...@ieee.org 
Kopie
Thema
EU DoC on 2.4GHz TX Modules






Dear Members, 
  
Is there any EU rule specified reqirements for a transmitter module?  My
questions are: 
  
1). Does CE mark apply to a transmitter module? 
2). If yes from 1), does a DoC need to include Low Voltage Directive and EMC
Directive? 
  
Thank you and look forward to hear from you. 
  
Best regards, 
Grace 
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Re: EU DoC on 2.4GHz TX Modules

2008-05-21 Thread peter merguerian
Grace
 
1) Yes
2) RTTE Directive and standards applied
 
Peter

Grace Lin graceli...@gmail.com wrote:

Dear Members,
 
Is there any EU rule specified reqirements for a transmitter module?  My
questions are:
 
1). Does CE mark apply to a transmitter module?
2). If yes from 1), does a DoC need to include Low Voltage Directive 
and EMC
Directive?
 
Thank you and look forward to hear from you.
 
Best regards,
Grace
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EU DoC on 2.4GHz TX Modules

2008-05-20 Thread Grace Lin
Dear Members,
 
Is there any EU rule specified reqirements for a transmitter module?  My
questions are:
 
1). Does CE mark apply to a transmitter module?
2). If yes from 1), does a DoC need to include Low Voltage Directive and EMC
Directive?
 
Thank you and look forward to hear from you.
 
Best regards,
Grace
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RE: EU DoC for Antennas

2007-12-17 Thread emc-p...@ieee.org
Greetings!

 

 For antenna itself (shipping separately and can work with different model of
products), is there any need for an EU DoC?

 

Please reference Interpretation of The 
http://ec.europa.eu/enterprise/rtte/interp.htm  Directive 1999/5/EC at Europa 

 

while paying particular attention to the following:

 

 http://ec.europa.eu/enterprise/rtte/tcam8.htm#antennas 23. Are
antennas covered by the Directive?

 

specifically:

 

3. Passive antennas are not considered as relevant components in their own
right under Article 2(c) of the RTTE Directive, and thus fall outside the
scope of the RTTE Directive if placed on the market as a single commercial
unit for distribution or final use. Passive antennas, if they are marketed in
conjunction with a radio product, will be subject to all the requirements of
the Directive as part of the overall radio product.

 

If the hyperlinks do not work for you the URL’s follow:

 

http://ec.europa.eu/enterprise/rtte/interp.htm

 

http://ec.europa.eu/enterprise/rtte/tcam8.htm#antennas

 

Alvin 

 

Disclaimer: The contents reflect the opinion of the author and are meant for
entertainment purposes only.

 

 

  _  

From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Grace Lin
Sent: Tuesday, December 11, 2007 7:31 AM
To: emc-p...@ieee.org
Subject: EU DoC for Antennas

 

Dear Members,

 

Does a manufacturer need to have an EU Declaration of Conformity for antennas
which work with hand-held remote controllers?  The antenna contains no
electronic circuit.  A RF device typically is certified with certain models of
antennas.  For antenna itself (shipping separately and can work with different
model of products), is there any need for an EU DoC? 

 

Is BNC connector (popular connector) a problem?

 

Thank you and look forward to hear from you.

 

Best regards,

Grace

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RE: EU DoC for Antennas

2007-12-12 Thread emc-p...@ieee.org
Per the guide on the recent LVD update, I think the answer is it depends. 
Here is an excerpt:

However, other electrical components which are intended to be incorporated
into other equipment and for which a risk assessment can be undertaken[7],
such as - transformers and electrical motors, are covered as such by the
Directive and must be CE marked.

If one were to make an inductive loop antenna that needed to be assessed for
hazardous voltage, it could be viewed in the same light as the transformer in
the excerpt.

As the RTTED includes the LVD and EMCD, it looks like at least some antennas
require a CE mark.

Don Umbdenstock
Manager Compliance Engineering

Tyco Safety Products / Sensormatic
6600 Congress Avenue
Boca Raton, FL 33487 USA
Phone: 561.912.6440 
djumbdenst...@tycoint.com


From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of John Woodgate
Sent: Tuesday, December 11, 2007 11:52 AM
To: emc-p...@ieee.org
Subject: Re: EU DoC for Antennas

In message 
2a93eb060712110730w1f0425c7u5d068e4249cf6...@mail.gmail.com, dated 
Tue, 11 Dec 2007, Grace Lin graceli...@gmail.com writes:

Does a manufacturer need to have an EU Declaration of Conformity for 
antennas which work with hand-held remote controllers?  The antenna 
contains no electronic circuit.  A RF device typically is certified 
with certain models of antennas.  For antenna itself (shipping 
separately and can work with different model of products), is there any 
need for an EU DoC?

I'm not entirely sure what the RTTE Directive requires, but I can't see 
that either the LVD or the EMCD requires a DoC for an antenna.

I would include with the antenna a list of the products it is intended 
to work with and a warning not to use it with any other product. (Just 
to show that all the 'angles' have been considered.)
 
Is BNC connector (popular connector) a problem?

In what way? I don't see any problem.
-- 
OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk
For very important information, please turn over.
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK

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Re: EU DoC for Antennas

2007-12-11 Thread emc-p...@ieee.org
In message 
8b3bf7a02b910640ab146a919ab3659404c5c...@exsvl03.hq.netapp.com, dated 
Tue, 11 Dec 2007, Kim, Ben ben@netapp.com writes:

For some intentional radiators, FCC doesn't allow to use popular 
connector/jack for antenna. Please check whether your products are 
regulated under FCC Part 15.203 or not.

The enquiry is in connection with the European market, so the FCC is 
irrelevant.
-- 
OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk
For very important information, please turn over.
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK

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RE: EU DoC for Antennas

2007-12-11 Thread emc-p...@ieee.org

 
For some intentional radiators, FCC doesn't allow to use popular
connector/jack for antenna. Please check whether your products are regulated
under FCC Part 15.203 or not.  

Ben Kim


From: John Woodgate [mailto:j...@jmwa.demon.co.uk]
Sent: Tuesday, December 11, 2007 8:52 AM
To: emc-p...@ieee.org
Subject: Re: EU DoC for Antennas

In message
2a93eb060712110730w1f0425c7u5d068e4249cf6...@mail.gmail.com, dated Tue, 11
Dec 2007, Grace Lin graceli...@gmail.com writes:

Does a manufacturer need to have an EU Declaration of Conformity for 
antennas which work with hand-held remote controllers?  The antenna 
contains no electronic circuit.  A RF device typically is certified 
with certain models of antennas.  For antenna itself (shipping 
separately and can work with different model of products), is there any 
need for an EU DoC?

I'm not entirely sure what the RTTE Directive requires, but I can't see that
either the LVD or the EMCD requires a DoC for an antenna.

I would include with the antenna a list of the products it is intended to work
with and a warning not to use it with any other product. (Just to show that
all the 'angles' have been considered.)
 
Is BNC connector (popular connector) a problem?

In what way? I don't see any problem.
--
OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk For very
important information, please turn over.
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK

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RE: EU DoC for Antennas

2007-12-11 Thread emc-p...@ieee.org
For some intentional radiators, FCC doesn't allow to use popular antenna.
Please check whether your products are regulated under FCC Part 15.203 or not.
 

Ben Kim


From: John Woodgate [mailto:j...@jmwa.demon.co.uk] 
Sent: Tuesday, December 11, 2007 8:52 AM
To: emc-p...@ieee.org
Subject: Re: EU DoC for Antennas

In message
2a93eb060712110730w1f0425c7u5d068e4249cf6...@mail.gmail.com, dated Tue, 11
Dec 2007, Grace Lin graceli...@gmail.com writes:

Does a manufacturer need to have an EU Declaration of Conformity for 
antennas which work with hand-held remote controllers?  The antenna 
contains no electronic circuit.  A RF device typically is certified 
with certain models of antennas.  For antenna itself (shipping 
separately and can work with different model of products), is there any 
need for an EU DoC?

I'm not entirely sure what the RTTE Directive requires, but I can't see that
either the LVD or the EMCD requires a DoC for an antenna.

I would include with the antenna a list of the products it is intended to work
with and a warning not to use it with any other product. (Just to show that
all the 'angles' have been considered.)
 
Is BNC connector (popular connector) a problem?

In what way? I don't see any problem.
--
OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk For very
important information, please turn over.
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK

-

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RE: EU DoC for Antennas

2007-12-11 Thread emc-p...@ieee.org

 


From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of John Woodgate
Sent: Tuesday, December 11, 2007 8:52 AM
To: emc-p...@ieee.org
Subject: Re: EU DoC for Antennas

In message
2a93eb060712110730w1f0425c7u5d068e4249cf6...@mail.gmail.com, dated Tue, 11
Dec 2007, Grace Lin graceli...@gmail.com writes:

 
Is BNC connector (popular connector) a problem?



A well-assembled BNC can be used in a lab environment from DC to about 1 GHz.
The BNC is very easy to mate / unmate, and it is not horribly expensive.
However, a test antenna is moved around during use, and puts stresses on the
attached cable. Since you want the antenna / cable assembly to be very
reliable, I wouldn't recommend using a BNC beyond about 30 MHz. Better results
will be had if you use a TNC or an N connector. If the antenna is being
carried on a mast carriage, then you should consider proper cable support to
keep the cable weight from hanging from the antenna connector.

Ed Price
ed.pr...@cubic.com WB6WSN
NARTE Certified EMC Engineer  Technician
Electromagnetic Compatibility Lab
Cubic Defense Applications
San Diego, CA  USA
858-505-2780 (Voice)
858-505-1583 (FAX)
Military  Avionics EMC Is Our Specialty
 

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Re: EU DoC for Antennas

2007-12-11 Thread emc-p...@ieee.org
In message 
2a93eb060712110730w1f0425c7u5d068e4249cf6...@mail.gmail.com, dated 
Tue, 11 Dec 2007, Grace Lin graceli...@gmail.com writes:

Does a manufacturer need to have an EU Declaration of Conformity for 
antennas which work with hand-held remote controllers?  The antenna 
contains no electronic circuit.  A RF device typically is certified 
with certain models of antennas.  For antenna itself (shipping 
separately and can work with different model of products), is there any 
need for an EU DoC?

I'm not entirely sure what the RTTE Directive requires, but I can't see 
that either the LVD or the EMCD requires a DoC for an antenna.

I would include with the antenna a list of the products it is intended 
to work with and a warning not to use it with any other product. (Just 
to show that all the 'angles' have been considered.)
 
Is BNC connector (popular connector) a problem?

In what way? I don't see any problem.
-- 
OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk
For very important information, please turn over.
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK

-

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EU DoC for Antennas

2007-12-11 Thread emc-p...@ieee.org
Dear Members,
 
Does a manufacturer need to have an EU Declaration of Conformity for antennas
which work with hand-held remote controllers?  The antenna contains no
electronic circuit.  A RF device typically is certified with certain models of
antennas.  For antenna itself (shipping separately and can work with different
model of products), is there any need for an EU DoC? 
 
Is BNC connector (popular connector) a problem?
 
Thank you and look forward to hear from you.
 
Best regards,
Grace
-  This
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EU DoC

2002-11-08 Thread SOUNDSURFR


In response to John's comment/question, the answer could well be that the
Commission and it's national enforcing authorities do not want to be faced
with the possibility of having chase 2(or even 3 or more under a multiple
branding situation) companies over a non-compliance/safety situation. Thus -
as far as Directives compliance is concerned - they want only 1 company to
take the responsibility for each product.

But there's no way for them to ensure that.  From what I can tell, there's 
nothing to stop several different different importers from importing the same 
product and independently issuing their own declarations for it.  If the 
product is found to be defective, all the importers of the product will 
theoretically be responsible - although I have no idea how the authorities 
might trace them. 

Greg Galluccio
www.productapprovals.com

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Re: EU DoC - ATEX Examples

2002-11-08 Thread SOUNDSURFR
In a message dated 11/8/02 7:56:16 AM Eastern Standard Time, 
chris_al...@eur.3com.com writes:

 
 Company B should issue the DoC. But to show due diligence they should 
 obtain a
 DoC (and copies of test reports) from Company A. 

That makes two DoC's for one product.  If company A issues a legally 
compliant DoC, why would company B issue one?  



Greg Galluccio
www.productapprovals.com


RE: EU DoC - ATEX Examples

2002-11-08 Thread Peter Merguerian

Dear All,

We should learn from the Australians. When there are multiple distributors
in Europe and in order not to have the file duplicated, you the
manufacturer, can use an Agent that can hold the file and the Declarations.
The agent number should then appear by the CE Mark.

I think this would solve many sleepless nights and will create jobs for the
unemployed as Agents.


All the Best,


This e-mail message may contain privileged or confidential information. If
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received this e-mail message in error, please return by forwarding the
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PETER S. MERGUERIAN
Technical Director
I.T.L. (Product Testing) Ltd.
26 Hacharoshet St., POB 211
Or Yehuda 60251, Israel
Tel: + 972-(0)3-5339022  Fax: + 972-(0)3-5339019
Mobile: + 972-(0)54-838175
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http://www.i-spec.com





-Original Message-
From: Chris Allen [mailto:chris_al...@eur.3com.com]
Sent: Friday, November 08, 2002 2:54 PM
To: John Woodgate
Cc: emc-p...@majordomo.ieee.org
Subject: Re: EU DoC - ATEX Examples





I thought  it was the person who placed the product on the market that was
responsible for issuing the DoC?

In this case there are 2 markets that the product is being placed on to. The
commercial market and the end user market.

Company B should issue the DoC. But to show due diligence they should
obtain a
DoC (and copies of test reports) from Company A. That way if it ever goes to
court, Company B can show that they showed due diligence in maintaining
appropriate documentation and that Company A is responsible for the failure
to
comply.

Chris.





John Woodgate j...@jmwa.demon.co.uk on 08/11/2002 09:39:21

Please respond to John Woodgate j...@jmwa.demon.co.uk

Sent by:  John Woodgate j...@jmwa.demon.co.uk


To:   emc-p...@majordomo.ieee.org
cc:(Chris Allen/GB/3Com)
Subject:  Re: EU DoC - ATEX Examples





I read in !emc-pstc that John Allen john.al...@era.co.uk wrote (in
BFE68AB0084CD311B4FB00508B014C8703CF9CD3@MERCURY) about 'EU DoC - ATEX
Examples' on Fri, 8 Nov 2002:
In response to John's comment/question, the answer could well be that the
Commission and it's national enforcing authorities do not want to be faced
with the possibility of having chase 2(or even 3 or more under a multiple
branding situation) companies over a non-compliance/safety situation. Thus
-
as far as Directives compliance is concerned - they want only 1 company to
take the responsibility for each product.

Maybe, but legally it won't wash. If Company B (marketer) were pursued
for a violation, its lawyers would immediately involve Company A
(manufacturer), and if they had previously earned their keep, that would
be based on the contract between A and B requiring A to provide a DOC in
every way and in every effect the same as if it were a DOC as required
by the relevant Directives.
--
Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk
Interested in professional sound reinforcement and distribution? Then go to
http://www.isce.org.uk
PLEASE do NOT copy news posts to me by E-MAIL!

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RE: EU DoC

2002-11-08 Thread Alexandru Guidea

Chris Allen wrote: Company B should raise a DoC  to sell the item under
it's own brand name. However, company B should obtain a DoC issued by
company A for it's own good.

My mistake. I overlooked the statement of the original message, which says
both companies are located in EU. Chris is right.

However, my message is true when at least company B is located elsewhere in
the world.

Alexandru Guidea.


-Original Message-
From: Chris Allen [mailto:chris_al...@eur.3com.com]
Sent: Thursday, November 07, 2002 2:34 AM
To: richwo...@tycoint.com
Cc: emc-p...@majordomo.ieee.org
Subject: Re: EU DoC





Company B should raise a DoC  to sell the item under it's own brand name.
However, company B should obtain a DoC issued by company A for it's own
good.

Chris.





richwo...@tycoint.com on 06/11/2002 18:22:08

Please respond to richwo...@tycoint.com

Sent by:  richwo...@tycoint.com


To:   emc-p...@majordomo.ieee.org
cc:(Chris Allen/GB/3Com)
Subject:  EU DoC







Company A builds a device for company B which sells the device in the EU
under their own brand name. The device is subject to a Declaration of
Conformity, and both companies are located within the EU. Must both
companies issue a Declaration?

Richard Woods
Sensormatic Electronics
Tyco International


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Re: EU DoC - ATEX Examples

2002-11-08 Thread John Woodgate

I read in !emc-pstc that John Allen john.al...@era.co.uk wrote (in
BFE68AB0084CD311B4FB00508B014C8703CF9CD3@MERCURY) about 'EU DoC - ATEX
Examples' on Fri, 8 Nov 2002:
In response to John's comment/question, the answer could well be that the
Commission and it's national enforcing authorities do not want to be faced
with the possibility of having chase 2(or even 3 or more under a multiple
branding situation) companies over a non-compliance/safety situation. Thus -
as far as Directives compliance is concerned - they want only 1 company to
take the responsibility for each product.

Maybe, but legally it won't wash. If Company B (marketer) were pursued
for a violation, its lawyers would immediately involve Company A
(manufacturer), and if they had previously earned their keep, that would
be based on the contract between A and B requiring A to provide a DOC in
every way and in every effect the same as if it were a DOC as required
by the relevant Directives.
-- 
Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk 
Interested in professional sound reinforcement and distribution? Then go to 
http://www.isce.org.uk
PLEASE do NOT copy news posts to me by E-MAIL!

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RE: EU DoC

2002-11-08 Thread John Allen

Nick

I can see your viewpoint, but I don't think I agree with you - I believe
that b(i) and b(ii) are alternatives - not additive.

In Clause 3 Intepretations of the UK EMC Regs Regulations (SI 99 No 2372)
it defines the responsible person as follows:

responsible person  in relation to relevant apparatus means-
 (a) the manufacturer thereof;
 (b) the manufacturer's authorised representative; or
 (c) where the manufacturer is not established in the Community and he has
not appointed an authorised representative, the person who supplies the
relevant apparatus;..

From the or at the end of (b)I take these to mean that (a), (b) and (c)
are alternatives - not an additive list.

See also my separate response today to John Woodgate's point about the
Commission's probably attitude to multiple signatories.

Regards

John Allen
Technical Consultant
Electromagnetics, Safety and Reliability Group
ERA Technology Ltd
Cleeve Rd
Leatherhead
Surrey KT22 7SA
Tel:+44 (0) 1372-367025 (Direct)
+44 (0) 1372-367000 (Switchboard)
Fax:+44 (0) 1372-367102 (Fax)

-Original Message-
From: Nick Williams [mailto:nick.willi...@conformance.co.uk]
Sent: 07 November 2002 21:54
To: John Allen
Cc: emc-p...@majordomo.ieee.org
Subject: RE: EU DoC


...but for an alternative view, Regulation 40 (2) of the UK's The 
Electromagnetic Compatibility Regulations 1992 (SI 1992:2372) says:


An EC declaration of conformity to which this regulation applies shall-

  (a) be in English;

  (b) give the name and address-

  (i) of the responsible person;

  (ii) where that person is not the manufacturer, of the manufacturer;

which I took to mean that both the manufacturer and their authorised 
representative should sign where the manufacturer is not resident in 
the EU.

Rgds

Nick.



At 16:55 + 7/11/02, John Allen wrote:
Hi Folks

Whilst investigating something else today, I came upon the Commission
Guidance Notes for the implementation of the ATEX Directive :

http://europa.eu.int/comm/enterprise/atex/guide/guide_en.pdf

On Page 112 in reply to Question 13 (about something else), Case 1, 2nd
paragraph, states the following:

The EC declaration of conformity and the application of the CE marking may
be effected either by the manufacturer or his authorised representative,
but
not by both.  .

Whilst this is ATEX-specific, I think it would appear reasonable to assume
that the Commission takes a similar line with the other CE Marking
directives.

The document does also contain more background and explanatory information
on this point and the Directive in general.

Regards

John Allen

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RE: EU DoC - ATEX Examples

2002-11-08 Thread John Allen

Hi Folks

In response to John's comment/question, the answer could well be that the
Commission and it's national enforcing authorities do not want to be faced
with the possibility of having chase 2(or even 3 or more under a multiple
branding situation) companies over a non-compliance/safety situation. Thus -
as far as Directives compliance is concerned - they want only 1 company to
take the responsibility for each product.

Regards

John Allen
Technical Consultant
Electromagnetics, Safety and Reliability Group
ERA Technology Ltd
Cleeve Rd
Leatherhead
Surrey KT22 7SA
Tel:+44 (0) 1372-367025 (Direct)
+44 (0) 1372-367000 (Switchboard)
Fax:+44 (0) 1372-367102 (Fax)

-Original Message-
From: John Woodgate [mailto:j...@jmwa.demon.co.uk]
Sent: 07 November 2002 20:37
To: emc-p...@majordomo.ieee.org
Subject: EU DoC - ATEX Examples



I read in !emc-pstc that John Allen john.al...@era.co.uk wrote (in
BFE68AB0084CD311B4FB00508B014C8703CF9CD2@MERCURY) about 'EU DoC  -
ATEX Examples' on Thu, 7 Nov 2002:

The EC declaration of conformity and the application of the CE marking may
be effected either by the manufacturer or his authorised representative,
but
not by both.  . 

Whilst this is ATEX-specific, I think it would appear reasonable to assume
that the Commission takes a similar line with the other CE Marking
directives.

Can you think of any justification at all for *banning* 'effecting' by
both? It seems not sensible to me. I doubt that they would both WANT to
do it, but that is beside the point.
-- 
Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk

Interested in professional sound reinforcement and distribution? Then go to 
http://www.isce.org.uk
PLEASE do NOT copy news posts to me by E-MAIL!

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in confidence.
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suffered as a result of accessing this message or any attachments.

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Re: EU DoC

2002-11-08 Thread John Woodgate

I read in !emc-pstc that Nick Williams nick.willi...@conformance.co.uk
wrote (in v04220803b9f0904184ca@[192.168.1.50]) about 'EU DoC' on Thu,
7 Nov 2002:
...but for an alternative view, Regulation 40 (2) of the UK's The 
Electromagnetic Compatibility Regulations 1992 (SI 1992:2372) says:


An EC declaration of conformity to which this regulation applies shall-

  (a) be in English;

  (b) give the name and address-

  (i) of the responsible person;

  (ii) where that person is not the manufacturer, of the manufacturer;

which I took to mean that both the manufacturer and their authorised 
representative should sign where the manufacturer is not resident in 
the EU.

That text doesn't say that *anyone* must sign!

People based in UK have to comply with the above, but other people need
only comply with the somewhat different approach indicated in the
Guidelines and Directives.

The UK Regulations were written before the Commission was asked about
OEM supply and other less simple cases, and have not been revised.
-- 
Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk 
Interested in professional sound reinforcement and distribution? Then go to 
http://www.isce.org.uk
PLEASE do NOT copy news posts to me by E-MAIL!

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RE: EU DoC

2002-11-07 Thread Nick Williams


...but for an alternative view, Regulation 40 (2) of the UK's The 
Electromagnetic Compatibility Regulations 1992 (SI 1992:2372) says:



An EC declaration of conformity to which this regulation applies shall-

 (a) be in English;

 (b) give the name and address-

 (i) of the responsible person;

 (ii) where that person is not the manufacturer, of the manufacturer;

which I took to mean that both the manufacturer and their authorised 
representative should sign where the manufacturer is not resident in 
the EU.


Rgds

Nick.



At 16:55 + 7/11/02, John Allen wrote:

Hi Folks

Whilst investigating something else today, I came upon the Commission
Guidance Notes for the implementation of the ATEX Directive :

http://europa.eu.int/comm/enterprise/atex/guide/guide_en.pdf

On Page 112 in reply to Question 13 (about something else), Case 1, 2nd
paragraph, states the following:

The EC declaration of conformity and the application of the CE marking may
be effected either by the manufacturer or his authorised representative, but
not by both.  .

Whilst this is ATEX-specific, I think it would appear reasonable to assume
that the Commission takes a similar line with the other CE Marking
directives.

The document does also contain more background and explanatory information
on this point and the Directive in general.

Regards

John Allen


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EU DoC - ATEX Examples

2002-11-07 Thread John Woodgate

I read in !emc-pstc that John Allen john.al...@era.co.uk wrote (in
BFE68AB0084CD311B4FB00508B014C8703CF9CD2@MERCURY) about 'EU DoC  -
ATEX Examples' on Thu, 7 Nov 2002:

The EC declaration of conformity and the application of the CE marking may
be effected either by the manufacturer or his authorised representative, but
not by both.  . 

Whilst this is ATEX-specific, I think it would appear reasonable to assume
that the Commission takes a similar line with the other CE Marking
directives.

Can you think of any justification at all for *banning* 'effecting' by
both? It seems not sensible to me. I doubt that they would both WANT to
do it, but that is beside the point.
-- 
Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk 
Interested in professional sound reinforcement and distribution? Then go to 
http://www.isce.org.uk
PLEASE do NOT copy news posts to me by E-MAIL!

---
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RE: EU DoC - ATEX Examples

2002-11-07 Thread John Allen

Hi Folks 

Whilst investigating something else today, I came upon the Commission
Guidance Notes for the implementation of the ATEX Directive :

http://europa.eu.int/comm/enterprise/atex/guide/guide_en.pdf

On Page 112 in reply to Question 13 (about something else), Case 1, 2nd
paragraph, states the following:

The EC declaration of conformity and the application of the CE marking may
be effected either by the manufacturer or his authorised representative, but
not by both.  . 

Whilst this is ATEX-specific, I think it would appear reasonable to assume
that the Commission takes a similar line with the other CE Marking
directives.

The document does also contain more background and explanatory information
on this point and the Directive in general.

Regards

John Allen
Technical Consultant
Electromagnetics, Safety and Reliability Group
ERA Technology Ltd
Cleeve Rd
Leatherhead
Surrey KT22 7SA
Tel:+44 (0) 1372-367025 (Direct)
+44 (0) 1372-367000 (Switchboard)
Fax:+44 (0) 1372-367102 (Fax)

-Original Message-
From: Chris Allen [mailto:chris_al...@eur.3com.com]
Sent: 07 November 2002 07:34
To: richwo...@tycoint.com
Cc: emc-p...@majordomo.ieee.org
Subject: Re: EU DoC





Company B should raise a DoC  to sell the item under it's own brand name.
However, company B should obtain a DoC issued by company A for it's own
good.

Chris.





richwo...@tycoint.com on 06/11/2002 18:22:08

Please respond to richwo...@tycoint.com

Sent by:  richwo...@tycoint.com


To:   emc-p...@majordomo.ieee.org
cc:(Chris Allen/GB/3Com)
Subject:  EU DoC







Company A builds a device for company B which sells the device in the EU
under their own brand name. The device is subject to a Declaration of
Conformity, and both companies are located within the EU. Must both
companies issue a Declaration?

Richard Woods
Sensormatic Electronics
Tyco International


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Re: EU DoC

2002-11-06 Thread SOUNDSURFR
Greg

I think your statement needs some clarification.

Even if it is produced by Company A, the DoC must clearly state the name and
model number of the Company B which sells the product in question in the EU,
so that the document is clearly and specifically associated with that
product as sold in the EU..

I agree.  The authorities have to be able to tie the product to the DoC.   I 
was going to go into that, but it seems like it would stand to reason. 


 Therefore I believe that many of the former would prefer to produce their
 own DoCs which made no mention of Company A - which should be OK as the
 Company B's are legally required to hold the supporting technical
 files/documentation prepared by Company A.


Agreed again.  From the standpoint of the authorities, it's probably better 
that company B issues the DoC.  However, from the standpoint of company B, 
who may not have as much control over production QC as they'd like, a 
declaration issued by Company A might be preferable.  I've seen joint declarat
ions, also, although I don't know what the Commission thinks about that.


Greg Galluccio
www.productapprovals.com


Re: EU DoC

2002-11-06 Thread SOUNDSURFR
In a message dated 11/6/02 4:42:04 PM Eastern Standard Time, gui...@cae.com 
writes:


 For the European law, company B is considered as manufacturer and shall
 issue the DoC. No point company A issues its own DoC.
 

I don't think that's entirely correct.  I think it depends on the 
relationship between A and B.


Greg Galluccio
www.productapprovals.com


Re: EU DoC

2002-11-06 Thread John Allen

Greg

I think your statement needs some clarification.

Even if it is produced by Company A, the DoC must clearly state the name and
model number of the Company B which sells the product in question in the EU,
so that the document is clearly and specifically associated with that
product as sold in the EU..

By comparison, if it were only to reference only the brand name and model
number of Company A, the document would have no obvious relationship to the
markings on the product itself. This would not go down well with inspecting
authorities such as UK Trading Standards Officers, who could reasonably
argue that the DoC - and thus the CE Marking - was of dubious provenance.

Furthermore, I think that some Company B's might be somewhat unhappy from
a marketing perspective to offer DoCs which clearly show that the product
was manufactured by someone else (Company A)  - and if multiple Company B's
sell exactly the same product from Company A (especially if they charge
different prices for it!).

Therefore I believe that many of the former would prefer to produce their
own DoCs which made no mention of Company A - which should be OK as the
Company B's are legally required to hold the supporting technical
files/documentation prepared by Company A.

Regards

John Allen
Technical Consultant
Electromagnetics, Safety and Reliability Group
ERA Technology Ltd
Cleeve Rd
Leatherhead
Surrey KT22 7SA
Tel: +44 (0) 1372-367025 (Direct)
+44 (0) 1372-367000 (Switchboard)
Fax: +44 (0) 1372-367102 (Fax)
(sent from my home email address)

- Original Message -
From: soundsu...@aol.com
To: emc-p...@majordomo.ieee.org
Sent: Wednesday, November 06, 2002 7:10 PM
Subject: Re: EU DoC



 Company A builds a device for company B which sells the device in the
EU
 under their own brand name. The device is subject to a Declaration of
 Conformity, and both companies are located within the EU. Must both
 companies issue a Declaration?

 No. A declaration from either company will suffice.



 Greg Galluccio
 www.productapprovals.com




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RE: EU DoC

2002-11-06 Thread Alexandru Guidea

For the European law, company B is considered as manufacturer and shall
issue the DoC. No point company A issues its own DoC.

The text of the EMC Directive reads the manufacturer
may subcontract certain operations, e.g., apparatus design or production,
provided that he retains overall control and responsibility for the
apparatus as a whole. By the same token, he may use ready-made items or
components, CE marked or not, to produce the apparatus without losing his
status as a manufacturer.

There are two ways company B ensures compliance with EU Directives:
1. Company B shall request from company A all necessary proof of compliance
with the relevant standards.
2. Company B qualifies the product and prepares supporting documentation.
Company B will do QA, audits and inspections at company A to ensure
consistency of all products with the test sample(s).

Alexandru Guidea
CAE Inc.
Montreal, CANADA 


-Original Message-
From: richwo...@tycoint.com [mailto:richwo...@tycoint.com]
Sent: Wednesday, November 06, 2002 1:22 PM
To: emc-p...@majordomo.ieee.org
Subject: EU DoC



Company A builds a device for company B which sells the device in the EU
under their own brand name. The device is subject to a Declaration of
Conformity, and both companies are located within the EU. Must both
companies issue a Declaration?

Richard Woods
Sensormatic Electronics
Tyco International


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Re: EU DoC

2002-11-06 Thread John Woodgate

I read in !emc-pstc that richwo...@tycoint.com wrote (in 846BF526A205F8
4BA2B6045BBF7E9A6A0467594A@flbocexu05) about 'EU DoC' on Wed, 6 Nov
2002:
Company A builds a device for company B which sells the device in the EU
under their own brand name. The device is subject to a Declaration of
Conformity, and both companies are located within the EU. Must both
companies issue a Declaration?

Only if both put it on the market. But if A does not market it, B would
be well advised to insist contractually on what is effectively a DOC
being supplied by A. 
-- 
Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk 
Interested in professional sound reinforcement and distribution? Then go to 
http://www.isce.org.uk
PLEASE do NOT copy news posts to me by E-MAIL!

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RE: EU DoC

2002-11-06 Thread Peter Merguerian

 
Rich,

Since company B puts the device into service under their own brand name,
they are the only ones that need to hold the DoC.]

Best Regards,

Peter Merguerian
-Original Message-
From: richwo...@tycoint.com
To: emc-p...@majordomo.ieee.org
Sent: 11/6/02 8:22 PM
Subject: EU DoC


Company A builds a device for company B which sells the device in the EU
under their own brand name. The device is subject to a Declaration of
Conformity, and both companies are located within the EU. Must both
companies issue a Declaration?

Richard Woods
Sensormatic Electronics
Tyco International


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Re: EU DoC

2002-11-06 Thread SOUNDSURFR

Company A builds a device for company B which sells the device in the EU
under their own brand name. The device is subject to a Declaration of
Conformity, and both companies are located within the EU. Must both
companies issue a Declaration?

No. A declaration from either company will suffice. 



Greg Galluccio
www.productapprovals.com




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EU DoC

2002-11-06 Thread richwoods



Company A builds a device for company B which sells the device in the EU
under their own brand name. The device is subject to a Declaration of
Conformity, and both companies are located within the EU. Must both
companies issue a Declaration?

Richard Woods
Sensormatic Electronics
Tyco International


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RE: EU DoC

2000-10-19 Thread Colgan, Chris

I would say that you have to list the amendments.

For instance some of our products currently comply with EN55013:1990 + A12 +
A13 and this is stated on the DoC.

I am currently re-testing these products to include A14:1999.  I will
re-issue the DoCs stating this.

If I just stated EN55013:1990 on the DoC, there would be no way of knowing
which version of the standard the products complied with unless the test
documentation was referred to.  Hardly precise, compete and clearly defined?

Just my humble opinion.

Chris

 -Original Message-
 From: wo...@sensormatic.com [SMTP:wo...@sensormatic.com]
 Sent: 19 October 2000 15:01
 To:   emc-p...@majordomo.ieee.org
 Subject:  EU DoC
 
 
 EN 45014:1998 specifies the General criteria for supplier's declaration
 of
 conformity.  Concerning the identification of standards, the document
 says
 the DoC shall contain the referenced normative documents in a precise,
 complete and clearly defined way . . .  The example of a DoC in Annex A
 lists the document number, title and edition/date of issue.
 
 Thus, it appears that EN60950 is not precise, complete and clearly
 defined since there is a 1992 and a 2000 version.
 
 Does EN60950:1992 meet the criteria or is necessary to list the applied
 amendments? e.g., EN60950:1992 + A1 + A2 + A3 + A4
 
 I require the latter in DoCs from my OEM suppliers so I will know that
 they
 are up to date, but I am not clear on just what is sufficient from a legal
 point of view.
 
 Richard Woods
 
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EU DoC

2000-10-19 Thread WOODS

EN 45014:1998 specifies the General criteria for supplier's declaration of
conformity.  Concerning the identification of standards, the document says
the DoC shall contain the referenced normative documents in a precise,
complete and clearly defined way . . .  The example of a DoC in Annex A
lists the document number, title and edition/date of issue.

Thus, it appears that EN60950 is not precise, complete and clearly
defined since there is a 1992 and a 2000 version.

Does EN60950:1992 meet the criteria or is necessary to list the applied
amendments? e.g., EN60950:1992 + A1 + A2 + A3 + A4

I require the latter in DoCs from my OEM suppliers so I will know that they
are up to date, but I am not clear on just what is sufficient from a legal
point of view.

Richard Woods

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Re: EU DoC

1997-07-15 Thread Horst Dierich
Phil Ford wrote:
 
 Jim Nadolny wrote
 
  I was told that the responsible person must be a resident of the EU.  
  A company in the States could not self certify and place the CE mark on 
  equipment with only the head of quality signature, assuming the head 
  of quality lives in Anytown USA.  I also heard that less than reputable 
  companies in the States find some European guy who will sign anything 
  and can vanish if the need arises.
 
 Article 10 of the EMC Directive states:
 1. ...shall be certified by an EC declaration of conformity issued by
 the manufacturer or his authorised representative established within the
 Community.
 ...
 Where neither the manufacturer nor his authorised representative is
 established within the Community, the above obligation to keep the EC
 declaration of conformity available shall be the responsibility of the
 person who places the apparatus on the Community market.
 
 The same requirements are then applied to the Technical Construction
 File.
 
 Unless there is something else I have missed, the manufacturer, his
 authorised representative and the person who keeps the DoC could all be
 resident outside the EU.
 --
 Regards,
 Phil Ford   phil_f...@uk.xyratex.com
 tel +44 (0)1705 443255fax +44 (0)1705 499315
 Xyratex, Langstone Road, Havant, PO9 1SA, United Kingdom

Sorry Phil,

but I have learned in a seminar for Product Safety at the Leuven University in 
Belgium by some expert Professors for European Rights that the responsible 
company 
or person must be a resident of one of the EU member states. This is stated by 
the 
term established within the Community. 
If there is no company involved for the import of the good into the EU, it is 
the 
person who brings the good to the EU - be it on his/her own benefit.
The company/person/authorized representative, or whoever imports the good into 
the 
EU must be residing within the EU.
-- 
Kind regards/mit freundlichen Gruessen,
Horst Dierich, Germany
EMAIL: dier...@ibm.net


EU DoC

1997-07-15 Thread Phil Ford
Horst Dierich wrote:

 Sorry Phil,
 
 but I have learned in a seminar for Product Safety at the Leuven University in
 Belgium by some expert Professors for European Rights that the responsible 
 company
 or person must be a resident of one of the EU member states. This is stated 
 by the
 term established within the Community.

Horst,
I think, in practical terms, you are quite right. There will usually be
a person or commercial body established within the EU who puts the
product on the market. This person or body will be responsible for the
DoC or the TCF.
However, the text of the Directive does allow that neither the
manufacturer nor his authorised representative is established within the
Community. What then would be the status of an individual importing a
product for personal use and not placing the apparatus on the Community
market? The Directive does not appear to say much about this situation
(probably rightly so).
-- 
Regards,
Phil Ford   phil_f...@uk.xyratex.com
tel +44 (0)1705 443255fax +44 (0)1705 499315
Xyratex, Langstone Road, Havant, PO9 1SA, United Kingdom


EU DoC

1997-07-14 Thread Phil Ford
Jim Nadolny wrote

 I was
 told
 that the responsible person must be a resident of the EU.  A company in
 the
 States could not self certify and place the CE mark on equipment with
 only the head of quality signature, assuming the head of quality lives
 in
 Anytown USA.  I also heard that less than reputable companies in the
 States
 find some European guy who will sign anything and can vanish if the
 need
 arises.

Article 10 of the EMC Directive states:
1. ...shall be certified by an EC declaration of conformity issued by
the manufacturer or his authorised representative established within the
Community.
...
Where neither the manufacturer nor his authorised representative is
established within the Community, the above obligation to keep the EC
declaration of conformity available shall be the responsibility of the
person who places the apparatus on the Community market.

The same requirements are then applied to the Technical Construction
File.

Unless there is something else I have missed, the manufacturer, his
authorised representative and the person who keeps the DoC could all be
resident outside the EU.
-- 
Regards,
Phil Ford   phil_f...@uk.xyratex.com
tel +44 (0)1705 443255fax +44 (0)1705 499315
Xyratex, Langstone Road, Havant, PO9 1SA, United Kingdom