Re: [PSES] Active Implantable Medical Devices

[Harris, Kevin J (DSC)]

Hi Grace

For your point 2

Under the RE-D for EMC compliance, you are not required to use a notified body 
if a particular standard is not listed in the OJEU.
See Articles 3(1)(b) and  17(2) of the RE-D

http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32014L0053=EN


Kind regards

Kevin




From: Grace Lin [mailto:graceli...@gmail.com]
Sent: Monday, April 03, 2017 1:35 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] Active Implantable Medical Devices


Dear Members,



For active implantable medical devices to comply with the RED requirements:



1.  Do all active implantable medical devices require Notified Body’s 
involvement per RED?  From online search 
(https://ec.europa.eu/growth/single-market/ce-marking/manufacturers_en<https://urldefense.proofpoint.com/v2/url?u=https-3A__ec.europa.eu_growth_single-2Dmarket_ce-2Dmarking_manufacturers-5Fen=DwMFaQ=0YGvTs3tT-VMy8_v51yLDw=opngXt0GJI9CAIpmFDu4mUv_xoHzGtzX8PosGAmQ4SY=PpPM367w6MVG8MaOZz-CW6nLegeKiGFCMhme5b5amOc=TPWHe5tJnrMBRWXN9ELlsMoCHqbLg-YRimZSeaMeTYA=>),
 it seems the answer is yes.  Could you please confirm?

2.  The 301 489 series EMC standards covering RED have not been 
published/harmonized.  For those manufacturers that do not want to wait for the 
harmonized standards to be published, should the manufacturers proceed with the 
DRAFT version of the standards (and send to NB)?

3.  Do you have any idea when 301 489 series standards covering RED will be 
published?  The current status is “On Approval”.



Thank you very much for your time and I look forward to hearing from you.



Best regards,

Grace Lin


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Re: [PSES] Active Implantable Medical Devices

[Schaefer, David]

ETSI EN 301 489 series addresses 3.1 of the RED, not 3.2, so use of the draft 
versions should be acceptable without a NB. The first sentence of the scope of 
ETSI EN 301 489-1:

The present document covers the essential requirements of article 3.1(b) of 
Directive 2014/53/EU [i.1] and article 6 of
Directive 2014/30/EU [i.2] for radio equipment and associated ancillary 
equipment, excluding broadcast receivers, in
respect of ElectroMagnetic Compatibility (EMC).

As for DC magnetic fields, those are being covered in other standards than the 
ETSI. No communication, so not really an RED problem. Instead, look at AAMI 
PC69, EN 45502-2-1, or ISO 14708-3. All test implantables to 50 mT at DC.

Thanks,

David


From: Grace Lin [mailto:graceli...@gmail.com]
Sent: 03 April 2017 06:35
To: EMC-PSTC@LISTSERV.IEEE.ORG<mailto:EMC-PSTC@LISTSERV.IEEE.ORG>
Subject: [PSES] Active Implantable Medical Devices


Dear Members,



For active implantable medical devices to comply with the RED requirements:



1.  Do all active implantable medical devices require Notified Body’s 
involvement per RED?  From online search 
(https://ec.europa.eu/growth/single-market/ce-marking/manufacturers_en), it 
seems the answer is yes.  Could you please confirm?

2.  The 301 489 series EMC standards covering RED have not been 
published/harmonized.  For those manufacturers that do not want to wait for the 
harmonized standards to be published, should the manufacturers proceed with the 
DRAFT version of the standards (and send to NB)?

3.  Do you have any idea when 301 489 series standards covering RED will be 
published?  The current status is “On Approval”.



Thank you very much for your time and I look forward to hearing from you.



Best regards,

Grace Lin


-


This message is from the IEEE Product Safety Engineering Society emc-pstc 
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Attachments are not permitted but the IEEE PSES Online Communities site at 
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Re: [PSES] Active Implantable Medical Devices

[Charlie Blackham]

Grace

I pressed “send” too early:

For devices operating in the 2483.5 to 2500 MHz band, ETSI EN 301 489-35 
V2.1.1<http://www.etsi.org/deliver/etsi_en/301400_301499/30148935/02.01.01_60/en_30148935v020101p.pdf>
 has been published by ETSI, and it is very likely that this will be listed in 
the OJ in April or May. However, a revision is already underway with Draft ETSI 
EN 301 489-35 
V2.2.0<http://www.etsi.org/deliver/etsi_en/301400_301499/30148935/02.02.00_20/en_30148935v020200a.pdf>
 due to become V2.2.1 before being listed in the OJ next year.

It would make sense to include this latest draft in your testing, so that you 
could list V2.1.1 on you DoC and update to v2.2.1 in due course with little, or 
perhaps no, additional testing.

Regards
Charlie

Charlie Blackham
Sulis Consultants Ltd
Tel: +44 (0)7946 624317
Web: 
www.sulisconsultants.com<https://outlook.hslive.net/owa/redir.aspx?C=02be3bf3e3a544d1bdf7b6c99fbd12f5=http%3a%2f%2fwww.sulisconsultants.com%2f>
Registered in England and Wales, number 05466247

From: Charlie Blackham [mailto:char...@sulisconsultants.com]
Sent: 03 April 2017 13:18
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] Active Implantable Medical Devices

Grace


  1.  The RED only requires the use of a Notified Body where Harmonised 
Standards have not been fully applied for article 3.2 (Radio Spectrum), as per 
article 17(3). Medical Device Directive requirements for Notified Bodies apply 
separately.
  2.  Whilst latest draft standards probably represent “state of the art”, they 
may change, and the manufacturer is free to choose the most appropriate 
standard, without having to consult a RED Notified Body
  3.  The progress of all ETSI standards being developed for RED can be checked 
at:
https://portal.etsi.org/webapp/WorkProgram/WorkItemPlan.asp?titleType=all=HIGHVERSION_ALL==TRUE=2014%2F53%2FEU_SUB_TB=True_MOVED_ON=_FLG=N_BOOLEAN=OR_BOOLEAN=OR_BOOLEAN=OR_OUTDATED==Search=FALSE=FALSE_TYPE=RPLAN=ALL

regards
Charlie

Charlie Blackham
Sulis Consultants Ltd
Tel: +44 (0)7946 624317
Web: 
www.sulisconsultants.com<https://outlook.hslive.net/owa/redir.aspx?C=02be3bf3e3a544d1bdf7b6c99fbd12f5=http%3a%2f%2fwww.sulisconsultants.com%2f>
Registered in England and Wales, number 05466247

From: Grace Lin [mailto:graceli...@gmail.com]
Sent: 03 April 2017 06:35
To: EMC-PSTC@LISTSERV.IEEE.ORG<mailto:EMC-PSTC@LISTSERV.IEEE.ORG>
Subject: [PSES] Active Implantable Medical Devices


Dear Members,



For active implantable medical devices to comply with the RED requirements:



1.  Do all active implantable medical devices require Notified Body’s 
involvement per RED?  From online search 
(https://ec.europa.eu/growth/single-market/ce-marking/manufacturers_en), it 
seems the answer is yes.  Could you please confirm?

2.  The 301 489 series EMC standards covering RED have not been 
published/harmonized.  For those manufacturers that do not want to wait for the 
harmonized standards to be published, should the manufacturers proceed with the 
DRAFT version of the standards (and send to NB)?

3.  Do you have any idea when 301 489 series standards covering RED will be 
published?  The current status is “On Approval”.



Thank you very much for your time and I look forward to hearing from you.



Best regards,

Grace Lin


-


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<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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List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
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For policy questions, send mail to:
Jim Bacher <j.bac...@ieee.org<mailto:j.bac...@ieee.org>>
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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 
<emc-p...@ieee.org<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-

Re: [PSES] Active Implantable Medical Devices

[Charlie Blackham]

Grace


  1.  The RED only requires the use of a Notified Body where Harmonised 
Standards have not been fully applied for article 3.2 (Radio Spectrum), as per 
article 17(3). Medical Device Directive requirements for Notified Bodies apply 
separately.
  2.  Whilst latest draft standards probably represent “state of the art”, they 
may change, and the manufacturer is free to choose the most appropriate 
standard, without having to consult a RED Notified Body
  3.  The progress of all ETSI standards being developed for RED can be checked 
at:
https://portal.etsi.org/webapp/WorkProgram/WorkItemPlan.asp?titleType=all=HIGHVERSION_ALL==TRUE=2014%2F53%2FEU_SUB_TB=True_MOVED_ON=_FLG=N_BOOLEAN=OR_BOOLEAN=OR_BOOLEAN=OR_OUTDATED==Search=FALSE=FALSE_TYPE=RPLAN=ALL

regards
Charlie

Charlie Blackham
Sulis Consultants Ltd
Tel: +44 (0)7946 624317
Web: 
www.sulisconsultants.com<https://outlook.hslive.net/owa/redir.aspx?C=02be3bf3e3a544d1bdf7b6c99fbd12f5=http%3a%2f%2fwww.sulisconsultants.com%2f>
Registered in England and Wales, number 05466247

From: Grace Lin [mailto:graceli...@gmail.com]
Sent: 03 April 2017 06:35
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] Active Implantable Medical Devices


Dear Members,



For active implantable medical devices to comply with the RED requirements:



1.  Do all active implantable medical devices require Notified Body’s 
involvement per RED?  From online search 
(https://ec.europa.eu/growth/single-market/ce-marking/manufacturers_en), it 
seems the answer is yes.  Could you please confirm?

2.  The 301 489 series EMC standards covering RED have not been 
published/harmonized.  For those manufacturers that do not want to wait for the 
harmonized standards to be published, should the manufacturers proceed with the 
DRAFT version of the standards (and send to NB)?

3.  Do you have any idea when 301 489 series standards covering RED will be 
published?  The current status is “On Approval”.



Thank you very much for your time and I look forward to hearing from you.



Best regards,

Grace Lin


-


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<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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List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
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For policy questions, send mail to:
Jim Bacher <j.bac...@ieee.org<mailto:j.bac...@ieee.org>>
David Heald <dhe...@gmail.com<mailto:dhe...@gmail.com>>

-

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<emc-p...@ieee.org>

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Attachments are not permitted but the IEEE PSES Online Communities site at 
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formats), large files, etc.

Website:  http://www.ieee-pses.org/
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Re: [PSES] Active Implantable Medical Devices

[McCallum, Andy]

John

TC 106 is for human exposure I was thinking of EMC issues - seems a gap here.

Andy

-Original Message-
From: John Woodgate [mailto:jmw1...@btinternet.com] 
Sent: 03 April 2017 09:45
To: McCallum, Andy <andy.mccal...@mottmac.com>; EMC-PSTC@LISTSERV.IEEE.ORG
Subject: RE: [PSES] Active Implantable Medical Devices

DC magnetic fields are outside the scope of ETSI, and fall within that of IEC 
TC106. Remember that the question was about the RED, and no-one as far as I 
know, uses DC magnetic fields for radio communication. I might except Gaia, 
because a very broad definition of radio might include communication between 
the geomagnetic field and compass needles. (;-) But that's not strictly DC, as 
it is well-known to vary, albeit rather slowly.

With best wishes DESIGN IT IN! OOO – Own Opinions Only www.jmwa.demon.co.uk J M 
Woodgate and Associates Rayleigh England

Sylvae in aeternum manent.

-Original Message-
From: McCallum, Andy [mailto:andy.mccal...@mottmac.com]
Sent: Monday, April 3, 2017 9:23 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] Active Implantable Medical Devices

Hi

Just had a brief scan of the standard and it doesn’t appear to cover immunity 
to DC Magnetic fields. I would have thought that many patients fitted with 
these devices would be having on going medical treatment such that they may 
require MRI scans, where they could be subject to magnetic fields of greater 
than 7T. Also wouldn't it be sensible to ensure that all devices met the ICNIRP 
exposure levels ?


Regards

Andy


-Original Message-
From: Dürrer Bernd [mailto:bernd.duer...@wilo.com]
Sent: 03 April 2017 08:37
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] AW: [PSES] Active Implantable Medical Devices

Dear Grace,

you can check the status and scheduled publication date (incl. citation in the 
OJ) of ETSI standards at 
https://portal.etsi.org/webapp/WorkProgram/SimpleSearch/QueryForm.asp

For the 301 489 series standards, click on "EN - European standard 
(Telecommunication series)" in the Type field and enter "301 489" (incl. the 
blank in the middle) as number. The search will return a table of work items: 
The "Status" column contains hyperlinks to the schedule of the standard, that 
includes the target date for citation in the OJ at the bottom of the table.

Kind regards,

Bernd



Von: Grace Lin [mailto:graceli...@gmail.com]
Gesendet: Montag, 3. April 2017 07:35
An: EMC-PSTC@LISTSERV.IEEE.ORG
Betreff: [PSES] Active Implantable Medical Devices

Dear Members,

For active implantable medical devices to comply with the RED requirements:

1.      Do all active implantable medical devices require Notified Body’s 
involvement per RED?  From online search 
(https://ec.europa.eu/growth/single-market/ce-marking/manufacturers_en), it 
seems the answer is yes.  Could you please confirm?
2.  The 301 489 series EMC standards covering RED have not been 
published/harmonized.  For those manufacturers that do not want to wait for the 
harmonized standards to be published, should the manufacturers proceed with the 
DRAFT version of the standards (and send to NB)?
3.  Do you have any idea when 301 489 series standards covering RED will be 
published?  The current status is “On Approval”.

Thank you very much for your time and I look forward to hearing from you.

Best regards,
Grace Lin

-

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discussion list. To post a message to the list, send your e-mail to 
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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
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Supervisory Board:
Prof. Dr. Norbert Wieselhuber

Dieses Dokument ist vertraulich zu behandeln. Die Weitergabe sowie 
Vervielfaeltigung, Verwertung und Mitteilung seines Inhalts ist nur mit unserer 
ausdruecklichen Genehmigung gestattet. Alle Rechte vorbehalten, insbesondere 
fuer den Fall der Schutzrechtsanmeldung.

This document has to be treated

Re: [PSES] AW: [PSES] Active Implantable Medical Devices

[John Woodgate]

It's true that there is such information, but I would treat it with caution. 
There can/will be delays in ETSI and even more in the citation process. Current 
hot topics are 'reasonably foreseeable' and 'dated references'. 

With best wishes DESIGN IT IN! OOO – Own Opinions Only
www.jmwa.demon.co.uk J M Woodgate and Associates Rayleigh England

Sylvae in aeternum manent.


-Original Message-
From: Dürrer Bernd [mailto:bernd.duer...@wilo.com] 
Sent: Monday, April 3, 2017 8:37 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] AW: [PSES] Active Implantable Medical Devices

Dear Grace,

you can check the status and scheduled publication date (incl. citation in the 
OJ) of ETSI standards at 
https://portal.etsi.org/webapp/WorkProgram/SimpleSearch/QueryForm.asp

For the 301 489 series standards, click on "EN - European standard 
(Telecommunication series)" in the Type field and enter "301 489" (incl. the 
blank in the middle) as number. The search will return a table of work items: 
The "Status" column contains hyperlinks to the schedule of the standard, that 
includes the target date for citation in the OJ at the bottom of the table.

Kind regards,

Bernd



Von: Grace Lin [mailto:graceli...@gmail.com]
Gesendet: Montag, 3. April 2017 07:35
An: EMC-PSTC@LISTSERV.IEEE.ORG
Betreff: [PSES] Active Implantable Medical Devices

Dear Members,

For active implantable medical devices to comply with the RED requirements:

1.  Do all active implantable medical devices require Notified Body’s 
involvement per RED?  From online search 
(https://ec.europa.eu/growth/single-market/ce-marking/manufacturers_en), it 
seems the answer is yes.  Could you please confirm?
2.  The 301 489 series EMC standards covering RED have not been 
published/harmonized.  For those manufacturers that do not want to wait for the 
harmonized standards to be published, should the manufacturers proceed with the 
DRAFT version of the standards (and send to NB)?
3.  Do you have any idea when 301 489 series standards covering RED will be 
published?  The current status is “On Approval”.

Thank you very much for your time and I look forward to hearing from you.

Best regards,
Grace Lin

-

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
List rules: http://www.ieee-pses.org/listrules.html
For help, send mail to the list administrators:
Scott Douglas <mailto:sdoug...@ieee.org>
Mike Cantwell <mailto:mcantw...@ieee.org>
For policy questions, send mail to:
Jim Bacher <mailto:j.bac...@ieee.org>
David Heald <mailto:dhe...@gmail.com>




WILO SE
Nortkirchenstrasse 100, 44263 Dortmund
Amtsgericht Dortmund, HRB 21356
www.wilo.com

Vorstand/Executive Board:
Oliver Hermes (Vorsitzender/Chairman), Dr. Markus Beukenberg, Carsten Krumm, 
Eric Lachambre, Mathias Weyers
Aufsichtsratsvorsitzender/Chairman of the Supervisory Board:
Prof. Dr. Norbert Wieselhuber

Dieses Dokument ist vertraulich zu behandeln. Die Weitergabe sowie 
Vervielfaeltigung, Verwertung und Mitteilung seines Inhalts ist nur mit unserer 
ausdruecklichen Genehmigung gestattet. Alle Rechte vorbehalten, insbesondere 
fuer den Fall der Schutzrechtsanmeldung.

This document has to be treated confidentially. Its contents are not to be 
passed on, duplicated, exploited or disclosed without our expressed permission. 
All rights reserved, especially the right to apply for protective rights.

-

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 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 <sdoug...@ieee.org>
Mike Cantwell <mcantw...@ieee.org>

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

-
---

Re: [PSES] Active Implantable Medical Devices

[John Woodgate]

OK. Neither CISPR or IEC TC77 regard the DC magnetic field as a significant EMI 
issue. In fact, it's really outside the scope of CISPR, although CISPR/B 
doesn't take much notice of that. The subject might be within the scope of IEC 
60601-1-2, but there is no indication that it is planned to introduce 
requirements.

With best wishes DESIGN IT IN! OOO – Own Opinions Only
www.jmwa.demon.co.uk J M Woodgate and Associates Rayleigh England

Sylvae in aeternum manent.


-Original Message-
From: McCallum, Andy [mailto:andy.mccal...@mottmac.com] 
Sent: Monday, April 3, 2017 10:00 AM
To: John Woodgate <jmw1...@btinternet.com>; EMC-PSTC@LISTSERV.IEEE.ORG
Subject: RE: [PSES] Active Implantable Medical Devices

John

TC 106 is for human exposure I was thinking of EMC issues - seems a gap here.

Andy

-Original Message-
From: John Woodgate [mailto:jmw1...@btinternet.com] 
Sent: 03 April 2017 09:45
To: McCallum, Andy <andy.mccal...@mottmac.com>; EMC-PSTC@LISTSERV.IEEE.ORG
Subject: RE: [PSES] Active Implantable Medical Devices

DC magnetic fields are outside the scope of ETSI, and fall within that of IEC 
TC106. Remember that the question was about the RED, and no-one as far as I 
know, uses DC magnetic fields for radio communication. I might except Gaia, 
because a very broad definition of radio might include communication between 
the geomagnetic field and compass needles. (;-) But that's not strictly DC, as 
it is well-known to vary, albeit rather slowly.

With best wishes DESIGN IT IN! OOO – Own Opinions Only www.jmwa.demon.co.uk J M 
Woodgate and Associates Rayleigh England

Sylvae in aeternum manent.

-Original Message-
From: McCallum, Andy [mailto:andy.mccal...@mottmac.com]
Sent: Monday, April 3, 2017 9:23 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] Active Implantable Medical Devices

Hi

Just had a brief scan of the standard and it doesn’t appear to cover immunity 
to DC Magnetic fields. I would have thought that many patients fitted with 
these devices would be having on going medical treatment such that they may 
require MRI scans, where they could be subject to magnetic fields of greater 
than 7T. Also wouldn't it be sensible to ensure that all devices met the ICNIRP 
exposure levels ?


Regards

Andy


-Original Message-
From: Dürrer Bernd [mailto:bernd.duer...@wilo.com]
Sent: 03 April 2017 08:37
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] AW: [PSES] Active Implantable Medical Devices

Dear Grace,

you can check the status and scheduled publication date (incl. citation in the 
OJ) of ETSI standards at 
https://portal.etsi.org/webapp/WorkProgram/SimpleSearch/QueryForm.asp

For the 301 489 series standards, click on "EN - European standard 
(Telecommunication series)" in the Type field and enter "301 489" (incl. the 
blank in the middle) as number. The search will return a table of work items: 
The "Status" column contains hyperlinks to the schedule of the standard, that 
includes the target date for citation in the OJ at the bottom of the table.

Kind regards,

Bernd



Von: Grace Lin [mailto:graceli...@gmail.com]
Gesendet: Montag, 3. April 2017 07:35
An: EMC-PSTC@LISTSERV.IEEE.ORG
Betreff: [PSES] Active Implantable Medical Devices

Dear Members,

For active implantable medical devices to comply with the RED requirements:

1.  Do all active implantable medical devices require Notified Body’s 
involvement per RED?  From online search 
(https://ec.europa.eu/growth/single-market/ce-marking/manufacturers_en), it 
seems the answer is yes.  Could you please confirm?
2.  The 301 489 series EMC standards covering RED have not been 
published/harmonized.  For those manufacturers that do not want to wait for the 
harmonized standards to be published, should the manufacturers proceed with the 
DRAFT version of the standards (and send to NB)?
3.  Do you have any idea when 301 489 series standards covering RED will be 
published?  The current status is “On Approval”.

Thank you very much for your time and I look forward to hearing from you.

Best regards,
Grace Lin

-

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
List rules: http://www.ieee-pses.org/listrules.html
For help, send mail to the list administrators:
Scott Douglas <mailto:sdoug...@ieee.org> Mike Cantwell 
<mailto:mcantw...@ieee.org> For policy questions, send mail to:
Jim Bacher <

Re: [PSES] Active Implantable Medical Devices

[John Woodgate]

DC magnetic fields are outside the scope of ETSI, and fall within that of IEC 
TC106. Remember that the question was about the RED, and no-one as far as I 
know, uses DC magnetic fields for radio communication. I might except Gaia, 
because a very broad definition of radio might include communication between 
the geomagnetic field and compass needles. (;-) But that's not strictly DC, as 
it is well-known to vary, albeit rather slowly.

With best wishes DESIGN IT IN! OOO – Own Opinions Only
www.jmwa.demon.co.uk J M Woodgate and Associates Rayleigh England

Sylvae in aeternum manent.

-Original Message-
From: McCallum, Andy [mailto:andy.mccal...@mottmac.com] 
Sent: Monday, April 3, 2017 9:23 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] Active Implantable Medical Devices

Hi

Just had a brief scan of the standard and it doesn’t appear to cover immunity 
to DC Magnetic fields. I would have thought that many patients fitted with 
these devices would be having on going medical treatment such that they may 
require MRI scans, where they could be subject to magnetic fields of greater 
than 7T. Also wouldn't it be sensible to ensure that all devices met the ICNIRP 
exposure levels ?


Regards

Andy


-Original Message-
From: Dürrer Bernd [mailto:bernd.duer...@wilo.com] 
Sent: 03 April 2017 08:37
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] AW: [PSES] Active Implantable Medical Devices

Dear Grace,

you can check the status and scheduled publication date (incl. citation in the 
OJ) of ETSI standards at 
https://portal.etsi.org/webapp/WorkProgram/SimpleSearch/QueryForm.asp

For the 301 489 series standards, click on "EN - European standard 
(Telecommunication series)" in the Type field and enter "301 489" (incl. the 
blank in the middle) as number. The search will return a table of work items: 
The "Status" column contains hyperlinks to the schedule of the standard, that 
includes the target date for citation in the OJ at the bottom of the table.

Kind regards,

Bernd



Von: Grace Lin [mailto:graceli...@gmail.com]
Gesendet: Montag, 3. April 2017 07:35
An: EMC-PSTC@LISTSERV.IEEE.ORG
Betreff: [PSES] Active Implantable Medical Devices

Dear Members,

For active implantable medical devices to comply with the RED requirements:

1.  Do all active implantable medical devices require Notified Body’s 
involvement per RED?  From online search 
(https://ec.europa.eu/growth/single-market/ce-marking/manufacturers_en), it 
seems the answer is yes.  Could you please confirm?
2.  The 301 489 series EMC standards covering RED have not been 
published/harmonized.  For those manufacturers that do not want to wait for the 
harmonized standards to be published, should the manufacturers proceed with the 
DRAFT version of the standards (and send to NB)?
3.  Do you have any idea when 301 489 series standards covering RED will be 
published?  The current status is “On Approval”.

Thank you very much for your time and I look forward to hearing from you.

Best regards,
Grace Lin

-

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
List rules: http://www.ieee-pses.org/listrules.html
For help, send mail to the list administrators:
Scott Douglas <mailto:sdoug...@ieee.org> Mike Cantwell 
<mailto:mcantw...@ieee.org> For policy questions, send mail to:
Jim Bacher <mailto:j.bac...@ieee.org>
David Heald <mailto:dhe...@gmail.com>




WILO SE
Nortkirchenstrasse 100, 44263 Dortmund
Amtsgericht Dortmund, HRB 21356
www.wilo.com

Vorstand/Executive Board:
Oliver Hermes (Vorsitzender/Chairman), Dr. Markus Beukenberg, Carsten Krumm, 
Eric Lachambre, Mathias Weyers Aufsichtsratsvorsitzender/Chairman of the 
Supervisory Board:
Prof. Dr. Norbert Wieselhuber

Dieses Dokument ist vertraulich zu behandeln. Die Weitergabe sowie 
Vervielfaeltigung, Verwertung und Mitteilung seines Inhalts ist nur mit unserer 
ausdruecklichen Genehmigung gestattet. Alle Rechte vorbehalten, insbesondere 
fuer den Fall der Schutzrechtsanmeldung.

This document has to be treated confidentially. Its contents are not to be 
passed on, duplicated, exploited or disclosed without our expressed permission. 
All rights reserved, especially the right to apply for protective rights.

-

This message is from the IEEE Product Safety Engineering Society em

Re: [PSES] Active Implantable Medical Devices

[McCallum, Andy]

Hi

Just had a brief scan of the standard and it doesn’t appear to cover immunity 
to DC Magnetic fields. I would have thought that many patients fitted with 
these devices would be having on going medical treatment such that they may 
require MRI scans, where they could be subject to magnetic fields of greater 
than 7T. Also wouldn't it be sensible to ensure that all devices met the ICNIRP 
exposure levels ?


Regards

Andy


-Original Message-
From: Dürrer Bernd [mailto:bernd.duer...@wilo.com] 
Sent: 03 April 2017 08:37
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] AW: [PSES] Active Implantable Medical Devices

Dear Grace,

you can check the status and scheduled publication date (incl. citation in the 
OJ) of ETSI standards at 
https://portal.etsi.org/webapp/WorkProgram/SimpleSearch/QueryForm.asp

For the 301 489 series standards, click on "EN - European standard 
(Telecommunication series)" in the Type field and enter "301 489" (incl. the 
blank in the middle) as number. The search will return a table of work items: 
The "Status" column contains hyperlinks to the schedule of the standard, that 
includes the target date for citation in the OJ at the bottom of the table.

Kind regards,

Bernd



Von: Grace Lin [mailto:graceli...@gmail.com]
Gesendet: Montag, 3. April 2017 07:35
An: EMC-PSTC@LISTSERV.IEEE.ORG
Betreff: [PSES] Active Implantable Medical Devices

Dear Members,

For active implantable medical devices to comply with the RED requirements:

1.  Do all active implantable medical devices require Notified Body’s 
involvement per RED?  From online search 
(https://ec.europa.eu/growth/single-market/ce-marking/manufacturers_en), it 
seems the answer is yes.  Could you please confirm?
2.  The 301 489 series EMC standards covering RED have not been 
published/harmonized.  For those manufacturers that do not want to wait for the 
harmonized standards to be published, should the manufacturers proceed with the 
DRAFT version of the standards (and send to NB)?
3.  Do you have any idea when 301 489 series standards covering RED will be 
published?  The current status is “On Approval”.

Thank you very much for your time and I look forward to hearing from you.

Best regards,
Grace Lin

-

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
List rules: http://www.ieee-pses.org/listrules.html
For help, send mail to the list administrators:
Scott Douglas <mailto:sdoug...@ieee.org> Mike Cantwell 
<mailto:mcantw...@ieee.org> For policy questions, send mail to:
Jim Bacher <mailto:j.bac...@ieee.org>
David Heald <mailto:dhe...@gmail.com>




WILO SE
Nortkirchenstrasse 100, 44263 Dortmund
Amtsgericht Dortmund, HRB 21356
www.wilo.com

Vorstand/Executive Board:
Oliver Hermes (Vorsitzender/Chairman), Dr. Markus Beukenberg, Carsten Krumm, 
Eric Lachambre, Mathias Weyers Aufsichtsratsvorsitzender/Chairman of the 
Supervisory Board:
Prof. Dr. Norbert Wieselhuber

Dieses Dokument ist vertraulich zu behandeln. Die Weitergabe sowie 
Vervielfaeltigung, Verwertung und Mitteilung seines Inhalts ist nur mit unserer 
ausdruecklichen Genehmigung gestattet. Alle Rechte vorbehalten, insbesondere 
fuer den Fall der Schutzrechtsanmeldung.

This document has to be treated confidentially. Its contents are not to be 
passed on, duplicated, exploited or disclosed without our expressed permission. 
All rights reserved, especially the right to apply for protective rights.

-

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 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 <sdoug...@ieee.org>
Mike Cantwell <mcantw...@ieee.org>

For policy questions, send mail to:
Jim Bacher:  <j.bac...@ieee.org>
David Heald: <dhe...@gmai

[PSES] AW: [PSES] Active Implantable Medical Devices

[Dürrer Bernd]

Dear Grace,

you can check the status and scheduled publication date (incl. citation in the 
OJ) of ETSI standards at 
https://portal.etsi.org/webapp/WorkProgram/SimpleSearch/QueryForm.asp

For the 301 489 series standards, click on "EN - European standard 
(Telecommunication series)" in the Type field and enter "301 489" (incl. the 
blank in the middle) as number. The search will return a table of work items: 
The "Status" column contains hyperlinks to the schedule of the standard, that 
includes the target date for citation in the OJ at the bottom of the table.

Kind regards,

Bernd



Von: Grace Lin [mailto:graceli...@gmail.com]
Gesendet: Montag, 3. April 2017 07:35
An: EMC-PSTC@LISTSERV.IEEE.ORG
Betreff: [PSES] Active Implantable Medical Devices

Dear Members,

For active implantable medical devices to comply with the RED requirements:

1.  Do all active implantable medical devices require Notified Body’s 
involvement per RED?  From online search 
(https://ec.europa.eu/growth/single-market/ce-marking/manufacturers_en), it 
seems the answer is yes.  Could you please confirm?
2.  The 301 489 series EMC standards covering RED have not been 
published/harmonized.  For those manufacturers that do not want to wait for the 
harmonized standards to be published, should the manufacturers proceed with the 
DRAFT version of the standards (and send to NB)?
3.  Do you have any idea when 301 489 series standards covering RED will be 
published?  The current status is “On Approval”.

Thank you very much for your time and I look forward to hearing from you.

Best regards,
Grace Lin

-

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
List rules: http://www.ieee-pses.org/listrules.html
For help, send mail to the list administrators:
Scott Douglas <mailto:sdoug...@ieee.org>
Mike Cantwell <mailto:mcantw...@ieee.org>
For policy questions, send mail to:
Jim Bacher <mailto:j.bac...@ieee.org>
David Heald <mailto:dhe...@gmail.com>




WILO SE
Nortkirchenstrasse 100, 44263 Dortmund
Amtsgericht Dortmund, HRB 21356
www.wilo.com

Vorstand/Executive Board:
Oliver Hermes (Vorsitzender/Chairman), Dr. Markus Beukenberg, Carsten Krumm, 
Eric Lachambre, Mathias Weyers
Aufsichtsratsvorsitzender/Chairman of the Supervisory Board:
Prof. Dr. Norbert Wieselhuber

Dieses Dokument ist vertraulich zu behandeln. Die Weitergabe sowie 
Vervielfaeltigung, Verwertung und Mitteilung seines Inhalts ist nur mit unserer 
ausdruecklichen Genehmigung gestattet. Alle Rechte vorbehalten, insbesondere 
fuer den Fall der Schutzrechtsanmeldung.

This document has to be treated confidentially. Its contents are not to be 
passed on, duplicated, exploited or disclosed without our expressed permission. 
All rights reserved, especially the right to apply for protective rights.

-

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 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 <sdoug...@ieee.org>
Mike Cantwell <mcantw...@ieee.org>

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

Re: [PSES] Active Implantable Medical Devices

[John Woodgate]

This one:
 
ETSI DRAFT FOR APPROVAL - EN 301 489-35 ElectroMagnetic Compatibility (EMC) 
standard
for radio equipment and services; Part 35: Specific requirements for Low Power 
Active
Medical Implants (LP-AMI) operating in the 2 483,5 MHz to 2 500 MHz bands; 
Harmonised
Standard covering the essential requirements of article 3.1(b) of Directive 
2014/53/EU (AP)
 
is out for national comment. I guess the ETSI closing date is around June 30, 
but that could mean that it is not published until September or later. You 
would have to ask the NB if they will work with a draft.
 
With best wishes DESIGN IT IN! OOO – Own Opinions Only
 <http://www.jmwa.demon.co.uk/> www.jmwa.demon.co.uk J M Woodgate and 
Associates Rayleigh England
 
Sylvae in aeternum manent.
 
From: Grace Lin [mailto:graceli...@gmail.com] 
Sent: Monday, April 3, 2017 6:35 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] Active Implantable Medical Devices
 
Dear Members,
 
For active implantable medical devices to comply with the RED requirements:
 
1.  Do all active implantable medical devices require Notified Body’s 
involvement per RED?  From online search 
(https://ec.europa.eu/growth/single-market/ce-marking/manufacturers_en), it 
seems the answer is yes.  Could you please confirm?
2.  The 301 489 series EMC standards covering RED have not been 
published/harmonized.  For those manufacturers that do not want to wait for the 
harmonized standards to be published, should the manufacturers proceed with the 
DRAFT version of the standards (and send to NB)?
3.  Do you have any idea when 301 489 series standards covering RED will be 
published?  The current status is “On Approval”.
 
Thank you very much for your time and I look forward to hearing from you.
 
Best regards,
Grace Lin
 
-

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[PSES] Active Implantable Medical Devices

[Grace Lin]

Dear Members,



For active implantable medical devices to comply with the RED requirements:



1.  Do all active implantable medical devices require Notified Body’s
involvement per RED?  From online search (
https://ec.europa.eu/growth/single-market/ce-marking/manufacturers_en), it
seems the answer is yes.  Could you please confirm?

2.  The 301 489 series EMC standards covering RED have not been
published/harmonized.  For those manufacturers that do not want to wait for
the harmonized standards to be published, should the manufacturers proceed
with the DRAFT version of the standards (and send to NB)?

3.  Do you have any idea when 301 489 series standards covering RED
will be published?  The current status is “On Approval”.



Thank you very much for your time and I look forward to hearing from you.



Best regards,

Grace Lin

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Re: [PSES] Interpretation for RoHS2 requirement (exemption of medical devices) of CE Marked device under MDD & transfer or ownership but same product

[Richard Nute]

 

 

Hi Leo:

 

It seems to me that all you need to do is change the name on the DOCs.  

 

Good luck, have a good Thanksgiving, and best regards,

Rich

 

 


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[PSES] Interpretation for RoHS2 requirement (exemption of medical devices) of CE Marked device under MDD & transfer or ownership but same product

[Leo Eisner]

Hello All,

I got an interesting set of questions: If the product, even though the same 
device, but co. Name has changed with a transfer of assets but with some of the 
same c-level executives, if they will need to consider the product now needs to 
meet the RoHS2 directive.  See below discussion and questions.

They are producing the same medical device as pre 2014 requirement for RoHS2 
exemption for medical devices but a new CE Mark as the co. Name has changed 
slightly.  They still need to be able to sell the same product. See detailed 
questions below.  Any specific guidance you can point too in this situation.  I 
can’t find anything specific to this situation which wouldn’t say they are 
placing on the market newly or recently which means meeting the RoHS2 as a 
medical device because past the date of the medical device exemption transition 
of placing on the market (as a new co. Name with a new CE Mark) but I am hoping 
not needed as a huge set-back for them otherwise.

Questions:
1) So, before the co. name change they originally “placed the product on the 
market” (CE Marked under MDD but as exempted Med Equip from the RoHS2) before 
the July 2014 exemption date.  So, not CE Marked under the RoHS2.  They are 
exempted with this original co. Name for the same product up til July 2019.  No 
question this is ok.
2) They say the product came off the market in April 2015 but if the same 
device goes back on the market after that would it have to go thru “placing on 
the market” again as it already happened back before July 2014 (so originally 
placed on the market)?  The question is 2 parted a) if the same co. Name as 
originally and b) with a new co. Name with the following background info.  For 
them it would put them back a couple years of work to get a newly qualified 
device that also meets RoHS2 requirements:
“Would the newly formed company STILL qualify?  Here is the situation: Up 
Med Corp. (’s the same for both company names) was purchased, and 
everything became the property of the new owner with the one exception of the 
UBI number (business license number for US).  Patents, product, model numbers, 
etc. were all purchased AS IS and will be used as such (so, we really will have 
the same exact model number).   The newly formed company is named Up 
Med Technology Inc., and along with this also came the rights to have the 
same nomenclature to be able to identify ourselves as “Up Med”.  
Switching the UBI has caused us to need to get a new CE Mark under our new 
business name, however, we were given some help/streamlining from the NB  since 
really the only changes are 1) Name 2) Address 3) Executive Management (and 
even that has 2 original members in it).  We are working on getting our 13485 
ISO Cert (Stage II audit coming early December).”
3) The existing product (mentioned in item 2) also has some parts that are end 
of life so they need to replace those parts but the part # or model # of the 
overall product will not change.  The parts they are replacing with may be RoHS 
compliant so, will this impact the RoHS2 requirements for the product?  Will it 
need to meet the ROHS2 requirements or can it still be exempt? To me this is 
closer to the requirement, but they would prefer not mention in their 
justification to the MDD NB nothing about parts being RoHS2 compliant in their 
justification. 
Thx much,

Leonard (Leo) Eisner, P.E.
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: l...@eisnersafety.com
Website: www.EisnerSafety.com
 

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Fo

RE: [PSES] Medical devices and Israel

[emc-p...@ieee.org]

A small correction to Peter answer: The Standards Institution of Israel (SII)
would the only body which issue a LETER recognized by Israeli Customs. 

Tests for import products in Israel can be conducted by any of the Designated
Laboratories. This designation is done by the Israeli Standardization
Commissioner which belong to the Israeli Ministry of Industry, Trade and
Labor. 

For Medical Electrical Equipment in Israel, IEC 60601-1 (with small
deviation-see below) and IEC 60601-1-2 (without deviations) are the accepted
standards.

 

4.7

A. Equipment that is to be connected to the mains, shall be intended for one
of the following voltages and frequencies:

Nominal frequency of 50Hz.

Nominal voltage of 230V for portable and hand-held equipment.

Nominal voltage 230V, for one phase equipment with input power not exceeding
4kVA.

Nominal voltage 400V, for multiphase equipment.

 

 

 

B. It is allowed to connect to the mains other equipment, with the following
ratings:

One phase equipment, for the range of 220 to 240 Volts.

Multiphase equipment, for the range of 380 to 440 Volts.

The equipment shall comply with all the requirements of the standard, while
being connected to the above mentioned mains frequencies and voltages, as if
it was marked for 50Hz and 230 or 400 Volts.

 

 

36

Change clause 36. - EMC – to:

The equipment shall comply with the requirements of SI 1011 part 1.2 (IEC
60601-1-2).

 

 

 

The steps which need to followed to enter in the Israeli Market are as follow:

 

The product (Medical Electrical Equipment) which will enter (first time) in
Israel shall be evaluated (full tested or assessed based on a CB
Certificate+TR) according 601-1 – based on this evaluation (which can be
done by Israeli Designated Laboratories: SII, ITL-Israel Testing Laboratories
and Hermon Laboratories) SII shall issue the Letter for Customs and  build a
“prototype” file. Based on this file, for each future  shipping, a sample
named “shin” will be assessed by SII for conformance with the
“prototype”.

 

Our lab can assist all which are interested on Israeli market.

 

I hope that the above clarify the issue.

 

Steli Loznen, M.Sc., SM-IEEE

Q.A  Certification Manager

I.T.L (Product Testing) Ltd.

Convener IEC/TC62/SC62A/WG17

1 Bat Sheva St., POB 87

Lod 71100, Israel

V: +972-(0)8-9153100 Ext.203

F: +972-(0)8-9153101

M: +972-(0)54-7245794

st...@itl.co.il

http://www.itl.co.il

 

From: peter merguerian [mailto:pmerguerian2...@yahoo.com] 
Sent: Tuesday, December 08, 2009 6:37 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] Medical devices and Israel

 

Derek,

 

Do you have the harmonized tariff code? The Standards Institution of Israel
(SII) would the the only laboratory in Israel able to test your product for
import. I can help you gain the SII approval if you wish if you serne me the
product brochure together with any test reports you might have for safety and
emc

 

Thanks, Peter

--- On Mon, 12/7/09, Derek Walton lfresea...@aol.com wrote:


From: Derek Walton lfresea...@aol.com
Subject: Medical devices and Israel
To: IEEE EMC  SAFETY PSTC emc-p...@ieee.org
Date: Monday, December 7, 2009, 2:34 PM

Hi folks,

A while back I tested a light box that goes on the wall of a Dr's 
office.
It's used for showing X-Ray films. I was asked to perform testing to
EN60601-2, which we did.

I have been asked to produce an EMC Certificate, but I must have missed 
where
the requirements for this came from. Can anyone enlighten me please.

Additionally, this morning, I'm informed that to import into Israel, 
the test
has to be performed by a Certified Electronics Laboratory: what is one of
those?

Many thanks,

Derfel Walton
L F Research

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Re: Medical devices and Israel

[emc-p...@ieee.org]

Derek,
 
Do you have the harmonized tariff code? The Standards Institution of Israel
(SII) would the the only laboratory in Israel able to test your product for
import. I can help you gain the SII approval if you wish if you serne me the
product brochure together with any test reports you might have for safety and
emc
 
Thanks, Peter

--- On Mon, 12/7/09, Derek Walton lfresea...@aol.com wrote:



From: Derek Walton lfresea...@aol.com
Subject: Medical devices and Israel
To: IEEE EMC  SAFETY PSTC emc-p...@ieee.org
Date: Monday, December 7, 2009, 2:34 PM


Hi folks,

A while back I tested a light box that goes on the wall of a Dr's 
office.
It's used for showing X-Ray films. I was asked to perform testing to
EN60601-2, which we did.

I have been asked to produce an EMC Certificate, but I must have missed 
where
the requirements for this came from. Can anyone enlighten me please.

Additionally, this morning, I'm informed that to import into Israel, 
the test
has to be performed by a Certified Electronics Laboratory: what is one of
those?

Many thanks,

Derfel Walton
L F Research

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Medical devices and Israel

[emc-p...@ieee.org]

Hi folks,

A while back I tested a light box that goes on the wall of a Dr's 
office. It's used for showing X-Ray films. I was asked to perform 
testing to EN60601-2, which we did.

I have been asked to produce an EMC Certificate, but I must have missed 
where the requirements for this came from. Can anyone enlighten me please.

Additionally, this morning, I'm informed that to import into Israel, the 
test has to be performed by a Certified Electronics Laboratory: what is 
one of those?

Many thanks,

Derfel Walton
L F Research

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New EMC Standard for Medical Devices in Japan

[emc-p...@ieee.org]

Group,
 
Thanks for the replies but does anyone have a pulse on when the new  EMC
Standard for Medical Devices will be published for Japan. JIS T 0601-X-X  ? 
Has anyone seen a draft version of this?
 
Regards,
 
Jeff Collins
Compliance  Reliability Consultant
Alcon Surgical Labs 

 
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Re: JIS EMC standards: EMC requirements for Medical Devices in Japan

[emc-p...@ieee.org]

On Thu, 11 Oct 2007 06:28:30 -0700 (PDT),
  jeff collins jeffcollin...@yahoo.com wrote:

 Does anyone have any current information regarding EMC requirements
 for Medical Devices in Japan?

JIS T 0601-1-2:2002 (corresponds to IEC 60601-1-2 ed.1) is still current,
although IEC 60601-1-2 ed.2 will also be accepted.

Regards,
Tom


Tomonori Sato  vef00...@nifty.ne.jp
URL: http://homepage3.nifty.com/tsato/

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JIS EMC standards: EMC requirements for Medical Devices in Japan

[emc-p...@ieee.org]

Dear List Members,

Does anyone have any current information regarding EMC requirements for
Medical Devices in Japan? 
 
Regards,
 
Jeff Collins
Compliance  Reliability Consultant
Alcon Surgical Labs 
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RE: CSA requirements for medical devices

[emc-p...@ieee.org]

Hello Paolo,

We have three labs with medical groups to assist you. Gianluca at our HQ
may be a good start:

Gianluca Arcari
gianluca.arc...@csa-international.org
(416) 747-4000

Or you may try Michel Brossoit
michel.bross...@csa-international.org 
(514) 428-2411

And our International Technical Contact for your area is Lu Soska who
can be very helpful
luanne.so...@csa-international.org
(216) 524-4990

Best regards,

Jason L. Chesley
CSA International
2210 Justin Trail
Alpharetta, GA 30004
P: (678) 992-0134
F: (770) 500-3948
jason.ches...@csa-international.org
www.csa-international.org


From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Paolo
Peruzzi
Sent: Wednesday, April 26, 2006 5:25 AM
To: emc-p...@ieee.org
Subject: CSA requirements for medical devices

Dear all,

I've been asked to make some modification on a CE marked medical device
in 
order to make it compliant with CSA requirements. 
Some modifications concern non-combustible enclosure and a dedicated
ground 
point. 
So I'm a little confused, cause I thought I had to simply follow the
last 
edition of CSA deviations to IEC 60601-1, but I haven't found anything
like 
that in it.
So where can I find all the needed technical requirements when I'm going
to 
sell a medical device in the canadian market?   

Thanks in advance,

Paolo Peruzzi
Regulatory Medical RD
El.En. S.p.A.
Via Baldanzese, 17
50041 Calenzano (FI)
Italy

Tel. +39 055 8826807
FAX  +39 055 8832884
http://www.elengroup.com/

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Re: CSA requirements for medical devices

[emc-p...@ieee.org]

If no success with CSA talk with Global Advantage in Toronto.
email ga...@globaladvantage.ca

Regards:
Kevin Keegan
Senior Associate
KES  Associates
1 Stonecroft Terrace
Kanata, Ontario
Canada K2K 2V1

Tel: 613-592-0820
Email: kkee...@kesandassociates.com
Web: http://www.kesandassociates.com
Regulatory Approval Forum Chairperson www.raft-global.org



On 26 Apr 2006 at 10:36, John Woodgate wrote:

 In message 2006042207.m77...@elen.it, dated Wed, 26 Apr 2006, 
 Paolo Peruzzi standa...@elen.it writes
 I've been asked to make some modification on a CE marked medical device 
 in order to make it compliant with CSA requirements. Some modifications 
 concern non-combustible enclosure and a dedicated ground point.
 
 Who is asking for these changes?
 
 So I'm a little confused, cause I thought I had to simply follow the 
 last edition of CSA deviations to IEC 60601-1, but I haven't found 
 anything like that in it. So where can I find all the needed technical 
 requirements when I'm going to sell a medical device in the canadian 
 market?
 
 Once again, first try asking CSA. If it works, you have the answer with 
 the greatest reliability. Particularly if CSA says you don't need to 
 make those changes.
 -- 
 OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk
 2006 is YMMVI- Your mileage may vary immensely.
 
 John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK
 
 -
 
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Re: CSA requirements for medical devices

[emc-p...@ieee.org]

In message 2006042207.m77...@elen.it, dated Wed, 26 Apr 2006, 
Paolo Peruzzi standa...@elen.it writes
I've been asked to make some modification on a CE marked medical device 
in order to make it compliant with CSA requirements. Some modifications 
concern non-combustible enclosure and a dedicated ground point.

Who is asking for these changes?

So I'm a little confused, cause I thought I had to simply follow the 
last edition of CSA deviations to IEC 60601-1, but I haven't found 
anything like that in it. So where can I find all the needed technical 
requirements when I'm going to sell a medical device in the canadian 
market?

Once again, first try asking CSA. If it works, you have the answer with 
the greatest reliability. Particularly if CSA says you don't need to 
make those changes.
-- 
OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk
2006 is YMMVI- Your mileage may vary immensely.

John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK

-

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CSA requirements for medical devices

[emc-p...@ieee.org]

Dear all,

I've been asked to make some modification on a CE marked medical device in 
order to make it compliant with CSA requirements. 
Some modifications concern non-combustible enclosure and a dedicated ground 
point. 
So I'm a little confused, cause I thought I had to simply follow the last 
edition of CSA deviations to IEC 60601-1, but I haven't found anything like 
that in it.
So where can I find all the needed technical requirements when I'm going to 
sell a medical device in the canadian market?   

Thanks in advance,

Paolo Peruzzi
Regulatory Medical RD
El.En. S.p.A.
Via Baldanzese, 17
50041 Calenzano (FI)
Italy

Tel. +39 055 8826807
FAX  +39 055 8832884
http://www.elengroup.com/

-

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wireless in medical devices

[owner-emc-p...@listserv.ieee.org]

Hi all,
could anybody tell me if there are particular restrictions in the use of a 
wireless kit in medical devices not for data transfer but for remote control 
and activation?
I'd like to know in particular if, for european market, it would be 
sufficient to certify the system according to MD directive and RTTE directive.
Thanks,


Paolo Peruzzi
Regulatory medical RD
El.En. S.p.A.
Via Baldanzese, 17
50041 Calenzano (FI)
Italy

Tel. +39 055 8826807
FAX  +39 055 8832884
http://www.elengroup.com/


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[Fwd: canadian requirements for medical devices]

[owner-emc-p...@listserv.ieee.org]

Paulo,

1. Your approval to ISO 13485 must be by a Notified Body or other
registrar which is accredited by the Canadian Medical Devices Conformity
Assessment System (CMDCAS)

2. The Canadian Medical Device Regulations are available at:
http://laws.justice.gc.ca/en/f-27/sor-98-282/text.html

3. Guidance on how to apply for a medical device licence is available at:
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/lcn_nw4_e.html

4. The frequently asked questions at:
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/quesans9_e.html
  may also be useful.

I hope this helps.

Regards,

Jon Griver
http://www.601help.com
The Medical Device Designers' Guide to IEC 60601-1



Subject: canadian requirements for medical devices
From:P. Peruzzi standa...@elen.it
List-Post: emc-pstc@listserv.ieee.org
Date:Tue, September 14, 2004 3:42 am
To:  emc-p...@ieee.org


Hi group,
I'm not familiar with canadian regulation and I've collected not very
clear answers on the matter; I'd like to know what exactly I have to do in
order to sell a medical device in Canada.
What I've understood is that my company should have a quality system in
compliance with Canadian version of 13485 (and it already has), and we
shall apply the medical devices canadian directive  
If it's correct, where can I find such a directive?
And what about technical standards?
I know only 601-1 deviations. Is there a sort of harmonized standards
list like fo EU MDD?

thanks in advance,

Paolo Peruzzi
El.En. S.p.A.
Via Baldanzese, 17
50041 Calenzano (FI)
Italy

Tel. +39 055 8826807
FAX  +39 055 8832884
http://www.elengroup.com/


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canadian requirements for medical devices

[owner-emc-p...@listserv.ieee.org]

Hi group,
I'm not familiar with canadian regulation and I've collected not very clear
answers on the matter; I'd like to know what exactly I have to do in order to
sell a medical device in Canada.
What I've understood is that my company should have a quality system in
compliance with Canadian version of 13485 (and it already has), and we shall
apply the medical devices canadian directive  
If it's correct, where can I find such a directive?
And what about technical standards?
I know only 601-1 deviations. Is there a sort of harmonized standards list
like fo EU MDD?

thanks in advance,

Paolo Peruzzi
El.En. S.p.A.
Via Baldanzese, 17
50041 Calenzano (FI)
Italy

Tel. +39 055 8826807
FAX  +39 055 8832884
http://www.elengroup.com/


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Re: Medical devices and voltage dip testing

[owner-emc-p...@majordomo.ieee.org]

I read in !emc-pstc that Pat Lawler pat.law...@verizon.net wrote (in
20040429172618.kxjh10678.out004.verizon@outgoing.verizon.net)
about 'Medical devices and voltage dip testing' on Thu, 29 Apr 2004:
EN60601-1-2:2001 (EMC requirements for general medical devices) requires
various 
voltage dip tests at the extremes of the rated input voltage range.
If a product is rated for 100-240Vac operation, this means test levels like 
40Vac for 100ms (100Vac/50Hz nominal input, 60% dip for 5 cycles). The 
performance criteria makes this especially difficult - The system shall
provide 
essential performance.

This looks like a major design change for many of our power supplies.

What has been the experience of list members designing power supplies or
systems 
to meet this requirement?  Have you found it to be a minor design challenge,
or 
are you still figuring out how to meet the test requirement?

It looks very much as though the 'world-wide' power supplies weren't
properly taken into account by TC 62 or SC62A. I suggest you contact
people concerned with those committees and ask them. There is a list of
officers available form the public part of the IEC web site:

http://www/iec.ch
-- 
Regards, John Woodgate, OOO - Own Opinions Only. 
The good news is that nothing is compulsory.
The bad news is that everything is prohibited.
http://www.jmwa.demon.co.uk Also see http://www.isce.org.uk 


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RE: Medical devices and voltage dip testing

[owner-emc-p...@majordomo.ieee.org]

Brent DeWitt wrote:

 that in the CDV (not law yet) of 1st amendment to 60601-1-2 we have
changed
essential performance from a defined term to an undefined term due to the
instability of IEC 60601-1 , which is still at the CDV stage.

My _personal_ opinion as a representative (and only that), is that: Thou
shall not fool the customer.

The 1st Amendment states quite clearly that the manufacturer will list
which
functions are essential functions in the user documentation. 

This is a hot potato, indeed. However, whenever a standard is made
stricter, complaints may be expected based on the idea that equipment which
has worked well enough for some considerable time is now judged unworthy of
approval, and the expense incurred complying with new requirements. No one
minds a new standard if all the old equipment passes! 

The question which provoked this thread related to power quality. UPS's and
batteries ARE one answer to that question. But those in the business of
writing standards might bear in mind the old adage: Be careful what you
ask for; you might get it.

I'll shut up now.

Disclaimer: My opinions, NOT those of my agency or where I work.

Cortland Richmond


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RE: Medical devices and voltage dip testing

[owner-emc-p...@majordomo.ieee.org]

First, I need to disclose my bias.  I am a member of the committee that
wrote 60601-1-2 2001.

Cortland is correct in bringing up the issue of essential performance.  Note
that in the CDV (not law yet) of 1st amendment to 60601-1-2 we have changed
essential performance from a defined term to an undefined term due to the
instability of IEC 60601-1 , which is still at the CDV stage.

My _personal_ opinion as a representative (and only that), is that: Thou
shall not fool the customer.

The 1st Amendment states quite clearly that the manufacturer will list which
functions are essential functions in the user documentation.

Note that anything I've said is ONLY MY opinion!

With respect,

Brent DeWitt


 -Original Message-
 From: owner-emc-p...@majordomo.ieee.org
 [mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of Cortland Richmond
 Sent: Thursday, April 29, 2004 8:03 PM
 To: ieee pstc list
 Subject: Re: Medical devices and voltage dip testing



 Pat Lawler posted:
  If a product is rated for 100-240Vac operation, this means test levels
 like 40Vac for 100ms (100Vac/50Hz nominal input, 60% dip for 5
 cycles). The
 performance criteria makes this especially difficult - The system shall
 provide essential performance. 

 Do not forget that, in large part, the *manufacturer* must say what
 essential performance is.

 Cortland
 Disclaimer: My opinions; NOT those of my agency or where I work.

 ---
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 Technical Committee emc-pstc discussion list.

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 http://www.ieeecommunities.org/emc-pstc



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Re: Medical devices and voltage dip testing

[owner-emc-p...@majordomo.ieee.org]

Pat Lawler posted:
 If a product is rated for 100-240Vac operation, this means test levels
like 40Vac for 100ms (100Vac/50Hz nominal input, 60% dip for 5 cycles). The
performance criteria makes this especially difficult - The system shall
provide essential performance. 

Do not forget that, in large part, the *manufacturer* must say what
essential performance is.  

Cortland
Disclaimer: My opinions; NOT those of my agency or where I work.


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Re: Medical devices and voltage dip testing

[owner-emc-p...@majordomo.ieee.org]

Hi Pat:


   If a product is rated for 100-240Vac operation, this 
   means test levels like 40Vac for 100ms (100Vac/50Hz 
   nominal input, 60% dip for 5 cycles). The performance 
   criteria makes this especially difficult - The system 
   shall provide essential performance.
   
   This looks like a major design change for many of our 
   power supplies.

My health insurance premiums are going to go up!

The way I read the requirement, the power supply 
output will need to be maintained through this 
dip.  Most power supplies cannot sustain the 
output with input that low for that long a period.

The requirement does indeed imply a MAJOR design
change for typical power supplies.  The 100 ms
time period (5 cycles) is really tough.  For a
switcher, it means some really big capacitors in
both the rectifier and the output.  It may also
mean the switcher will need to work at even lower
voltages.

The power supply will be bigger and more expensive.


Good luck,
Rich






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Medical devices and voltage dip testing

[owner-emc-p...@majordomo.ieee.org]

EN60601-1-2:2001 (EMC requirements for general medical devices) requires
various voltage dip tests at the extremes of the rated input voltage range.
If a product is rated for 100-240Vac operation, this means test levels like
40Vac for 100ms (100Vac/50Hz nominal input, 60% dip for 5 cycles). The
performance criteria makes this especially difficult - The system shall
provide essential performance.

This looks like a major design change for many of our power supplies.

What has been the experience of list members designing power supplies or
systems to meet this requirement?  Have you found it to be a minor design
challenge, or are you still figuring out how to meet the test requirement?

---
Pat Lawler
pat.law...@verizon.net



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RE: PVC in Medical Devices

[Joshua Wiseman]

Peter,

I don't know much about Medical, but I have heard from some of our major
customers that PVC use needs to be reduced because of chemicals covered under
WEEE.

Josh


From: peter.valent...@us.datex-ohmeda.com
[mailto:peter.valent...@us.datex-ohmeda.com]
Sent: Wednesday, October 15, 2003 8:51 AM
To: emc-p...@majordomo.ieee.org
Subject: PVC in Medical Devices



Are there formal requirements requiring that PVC (Poly Vinyl Chloride) NOT
be used in medical device materials?  If so, what are they called, and can
there be exceptions to these rules.

From my understanding, there are only informal ones that medical device
manufacturers should adhere to for example when selling in Europe.

The insulating shrink material used on Nickel Metal Hydride batteries
consists of PVC.  Almost all battery suppliers use the same shrink material
sold in many parts of the world.  It would appear that this may be a
concern.

Thanks
Peter Valentyik





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PVC in Medical Devices

[peter.valent...@us.datex-ohmeda.com]

Are there formal requirements requiring that PVC (Poly Vinyl Chloride) NOT
be used in medical device materials?  If so, what are they called, and can
there be exceptions to these rules.

From my understanding, there are only informal ones that medical device
manufacturers should adhere to for example when selling in Europe.

The insulating shrink material used on Nickel Metal Hydride batteries
consists of PVC.  Almost all battery suppliers use the same shrink material
sold in many parts of the world.  It would appear that this may be a
concern.

Thanks
Peter Valentyik





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Medical devices

[Kim Boll Jensen]

Hi all

Can some one send me a copy of CCA 227-7 Rotine tests for medical equipment,
or point me to a downloadeable fil.

Best regards,

Kim Boll Jensen
Bolls Rådgivning
Hyacintvej 6
DK-3660 Stenløse

Tlf.:  48 18 35 66
Fax:   48 18 35 30
Mobil: 22 99 69 91

E-mail: k...@bolls.dk
web: www.bolls.dk




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RE: RTTE for Medical Devices?

[Brent DeWitt]

Del,
 
I'm not an RTTE expert, but from the MDD side under the 2nd edition of
60601-1-2 (2001), the function of the card and it's communications would have
to be evaluated.  If it falls under the ESSENTIAL FUNCTION of the medical
device, it would be subject to the requirements of 60601-1-2.  These
requirements are somewhat more stringent than the RTTE directive.
 
That probably doesn't help much, but it's a bit more information.
 
Regards,
 
Brent DeWitt


From: owner-emc-p...@majordomo.ieee.org
[mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of D.Han
Sent: Friday, July 18, 2003 4:20 PM
To: emc-p...@majordomo.ieee.org
Subject: RTTE for Medical Devices?



Hi All,


I would appreciate your thoughts on the following scenario:

 

Company A designs a medical product that incorporates a wireless device, lets
say, a wireless PCI card. The wireless card is manufactured by Company B and
has been evaluated to the RTTE directive and thus CE-marked. This wireless
card is installed in the end medical product, unmodified and according to
manufacturers instructions.

 

Company As name goes onto the end product, but Company Bs name, markings,
labeling etc. remain on the wireless card. Would Company A need to consider
RTTE (in addition to the MDD) for their end product? If yes, what additional
testing would this encompass? 

 

Thanks!

Del



  _  

Do you Yahoo!?
SBC  http://pa.yahoo.com/*http://rd.ya
oo.com/evt=1207/*http://promo.yahoo.com/sbc/ Yahoo! DSL - Now only $29.95 per
month!

RTTE for Medical Devices?

[D.Han]

Hi All,


I would appreciate your thoughts on the following scenario:

 

Company A designs a medical product that incorporates a wireless device,
let’s say, a wireless PCI card. The wireless card is manufactured by Company
B and has been evaluated to the RTTE directive and thus CE-marked. This
wireless card is installed in the end medical product, unmodified and
according to manufacturer’s instructions.

 

Company A’s name goes onto the end product, but Company B’s name,
markings, labeling etc. remain on the wireless card. Would Company A need to
consider RTTE (in addition to the MDD) for their end product? If yes, what
additional testing would this encompass? 

 

Thanks!

Del


  _  

Do you Yahoo!?
SBC Yahoo! DSL http://pa.yahoo.com/*ht
p://rd.yahoo.com/evt=1207/*http://promo.yahoo.com/sbc/  - Now only $29.95 per
month!

RE: Medical Devices Environmental Requirements

[Peter Merguerian]

Joel Hello!

I do not know the use of your medical device really does. But there are
various types of standards which you can use. We recently evaluated a
medical device which was worn on the wrist and which transmitted radio
signals to a base station much like a cellular telephone. For environmental
tests, we used the European ETSI standard ETS 300 019-2-7, Environmental
conditions and environmental tests for telecommunication equipment. Part
2-7 Specification of environmental tests Portable and non-stationary uise

To satisfy the FDA, you could also apply MIL-STD-810E which specifies
Mechanical Shock, Vibration and Altitude Testing.


All the Best from the same country.


This e-mail message may contain privileged or confidential information. If
you are not the intended recipient, you may not disclose, use, disseminate,
distribute, copy or rely upon this message or attachment in any way. If you
received this e-mail message in error, please return by forwarding the
message and its attachments to the sender.



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
http://www.itl.co.il
http://www.i-spec.com





-Original Message-
From: Mandel, Joel [mailto:joel_man...@adc.com]
Sent: Tuesday, November 05, 2002 6:43 PM
To: 'emc-p...@majordomo.ieee.org'
Subject: Medical Devices Environmental Requirements



Hi All
 Can anybody help me out with Environmental testing requirement/Standards
(Temp,Vibration) for medical devices?
Thank You
Joel Mandel
Reliability Dept
ADC Israel

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Re: Medical Devices Environmental Requirements

[Alan E Hutley]

Have you tried
http://europa.eu.int/comm/enterprise/medical_devices/index.htm

Cheers
Alan E Hutley
EMC Compliance Journal
www.compliance-club.com

- Original Message -
From: Jim Conrad jc...@shore.net
To: Naftali Shani nsh...@catena.com; 'Mandel, Joel'
joel_man...@adc.com; emc-p...@majordomo.ieee.org
Sent: Tuesday, November 05, 2002 8:03 PM
Subject: RE: Medical Devices Environmental Requirements



 Have you checked 60601-1?

 Jim

 -Original Message-
 From: owner-emc-p...@majordomo.ieee.org
 [mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of Naftali Shani
 Sent: Tuesday, November 05, 2002 1:27 PM
 To: 'Mandel, Joel'; 'emc-p...@majordomo.ieee.org'
 Subject: RE: Medical Devices Environmental Requirements


 Are there any customers-specific requirements? In the telecom
 industry,
 NEBS/ETSI (Telcordia GR-63  ETS 300 019) come to mind.

 Regards,
 Naftali Shani, Catena Networks (www.catena.com)
 307 Legget Drive, Ottawa, Ontario, Canada K2K 3C8
 613.599.6430/866.2CATENA (X.8277); C 295.7042; F 599.0445
 E-mail: nsh...@catena.com

  -Original Message-
 From:   Mandel, Joel [mailto:joel_man...@adc.com]
 Sent:   Tuesday, November 05, 2002 11:43 AM
 To: 'emc-p...@majordomo.ieee.org'
 Subject:Medical Devices Environmental Requirements


 Hi All
  Can anybody help me out with Environmental testing
 requirement/Standards
 (Temp,Vibration) for medical devices?
 Thank You
 Joel Mandel
 Reliability Dept
 ADC Israel

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RE: Medical Devices Environmental Requirements

[Ned Devine]

Hi,

In the USA the FDA has a guidance document that some of the branch's (i.e.
Anesthesiology and Respiratory) use.  See
http://www.fda.gov/cdrh/ode/638.pdf  

This includes both EMI, and mechanical and environmental requirements.

Ned Devine
Entela, Inc.
3033 Madison Ave. SE
Grand Rapids, MI  49548

Phone: 616 248 9671
Fax: 616 574 9752
e-mail: ndev...@entela.com
www.entela.com 
Entela, Inc. A Certified Woman Owned Business 




 



-Original Message-
From: Mandel, Joel [mailto:joel_man...@adc.com]
Sent: Tuesday, November 05, 2002 11:43 AM
To: 'emc-p...@majordomo.ieee.org'
Subject: Medical Devices Environmental Requirements



Hi All
 Can anybody help me out with Environmental testing requirement/Standards
(Temp,Vibration) for medical devices?
Thank You
Joel Mandel
Reliability Dept
ADC Israel

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RE: Medical Devices Environmental Requirements

[Jim Conrad]

Have you checked 60601-1?

Jim

-Original Message-
From: owner-emc-p...@majordomo.ieee.org
[mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of Naftali Shani
Sent: Tuesday, November 05, 2002 1:27 PM
To: 'Mandel, Joel'; 'emc-p...@majordomo.ieee.org'
Subject: RE: Medical Devices Environmental Requirements


Are there any customers-specific requirements? In the telecom
industry,
NEBS/ETSI (Telcordia GR-63  ETS 300 019) come to mind.

Regards,
Naftali Shani, Catena Networks (www.catena.com)
307 Legget Drive, Ottawa, Ontario, Canada K2K 3C8
613.599.6430/866.2CATENA (X.8277); C 295.7042; F 599.0445
E-mail: nsh...@catena.com

 -Original Message-
From:   Mandel, Joel [mailto:joel_man...@adc.com]
Sent:   Tuesday, November 05, 2002 11:43 AM
To: 'emc-p...@majordomo.ieee.org'
Subject:Medical Devices Environmental Requirements


Hi All
 Can anybody help me out with Environmental testing
requirement/Standards
(Temp,Vibration) for medical devices?
Thank You
Joel Mandel
Reliability Dept
ADC Israel

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(Fwd) Medical Devices Environmental Requirements

[jgriver]

Joel,

To the best of my knowledge, there are no specific environmental standards for 
medical equipment.

IEC 60601-1, (the product safety standard), clause 10.1, states  Equipment 
shall be capable, while 
packed for transport and storage, of being exposed to environmental conditions 
as stated by the 
manufacturer.

Clause 10.2.1 specifies ambient temperature, relative humidity and atmospheric 
pressure ranges for 
operation in normal use.

Particular types of medical equipment, which are required to comply with one of 
the  IEC 60601-2-XX 
standards, may be subject to additional or different environmental requirements.

Regards,

Jon Griver
http://www.601help.com
The Medical Device Developer's Guide to IEC 60601-1


Hi All
 Can anybody help me out with Environmental testing requirement/Standards
(Temp,Vibration) for medical devices?
Thank You
Joel Mandel
Reliability Dept
ADC Israel



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RE: Medical Devices Environmental Requirements

[Naftali Shani]

Are there any customers-specific requirements? In the telecom industry,
NEBS/ETSI (Telcordia GR-63  ETS 300 019) come to mind.

Regards,
Naftali Shani, Catena Networks (www.catena.com)
307 Legget Drive, Ottawa, Ontario, Canada K2K 3C8
613.599.6430/866.2CATENA (X.8277); C 295.7042; F 599.0445
E-mail: nsh...@catena.com

 -Original Message-
From:   Mandel, Joel [mailto:joel_man...@adc.com] 
Sent:   Tuesday, November 05, 2002 11:43 AM
To: 'emc-p...@majordomo.ieee.org'
Subject:Medical Devices Environmental Requirements


Hi All
 Can anybody help me out with Environmental testing requirement/Standards
(Temp,Vibration) for medical devices?
Thank You
Joel Mandel
Reliability Dept
ADC Israel

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Medical Devices Environmental Requirements

[Mandel, Joel]

Hi All
 Can anybody help me out with Environmental testing requirement/Standards
(Temp,Vibration) for medical devices?
Thank You
Joel Mandel
Reliability Dept
ADC Israel

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RE: Distributors of Medical Devices in Europe

[Mark Schmidt]

Hi Neil,
Thanks for your response. Let me see if I can clarify. The product we are 
talking about is Class 1 device. We have offices and service centers in the UK, 
Germany and France. In addition to this we use a network of distributors. These 
distributors for this device in question are medical device distributors. 
Currently we manufacture product here in the US but that could change in the 
future. To date we have product that fall into ITE, Laboratory equipment and 
Medical categories. We currently have DOC for this device in question and it 
conforms with the MDD. According to Article 14, COUNCIL DIRECTIVE 93/42/EEC it 
indicates informing the competent authorities in that member state. Thus my 
confusion, I did not concern myself with this issue until recently, when the 
question was asked, Are there any requirements for European Distributors of 
Medical Devices . 
Article 14
Article 14
Registration of persons responsible for placing devices on the market
1. Any manufacturer who, under his own name, places devices on the market in 
accordance with the procedures referred to in Article 11 (5) and (6) and any 
other natural or legal person engaged in the activities referred to in Article 
12 shall inform the competent authorities of the Member State in which he has 
his registered place of business of the address of the registered place of 
business and the description of the devices concerned.
2. Where a manufacturer who places devices referred to in paragraph 1 on the 
market under his own name does not have a registered place of business in a 
Member State, he shall designate the person(s) responsible for marketing them 
who is (are) established in the Community. These persons shall inform the 
competent authorities of the Member State in which they have their registered 
place of business of the address of the registered place of business and the 
category of devices concerned.
3. The Member States shall on request inform the other Member States and the 
Commission of the details referred to in paragraphs 1 and 2.
Thank you,

Mark Schmidt
Regulatory Compliance 
X-Rite Incorporated 
Grandville, MI 
USA
(616) 257 2469
mschm...@xrite.com



 -Original Message-
From:   Barker, Neil [mailto:neil.bar...@e2vtechnologies.com] 
Sent:   Wednesday, September 18, 2002 11:29 AM
To: Mark Schmidt; emc-p...@majordomo.ieee.org
Subject:RE: Distributors of Medical Devices in Europe

  File: Neil R. Barker (E-mail).vcf  In general a Class 1 Medical Device 
requires only a manufacturer's
Declaration of Conformity before it is placed on the market.  However, in
the context of the Medical Devices Directive the manufacturer is not the
person or entity who makes the product but the person or entity who places
the product on the EU market in their own name. Hence a manufacturer can be
one person in an office who contracts with others to design and manufacture
a product which is then placed on the market under a label, Brand X, that
belongs to the one-person company. It is the responsibility of that
one-person company to issue the Declaration of Conformity, and it is their
responsibility to ensure that all the requirements of the MDD are met.
In the case of Distributors, it is the responsibility of the original
importer into the EU, but not of further distibution thereafter. It is worth
reading the Directive itself. It is not that large a document and is quite
readable.

Best regards,

Neil R. Barker
Compliance Engineering Manager
E2V Technologies
Waterhouse Lane
Chelmsford
Essex
CM1 2QU
U.K.

Tel: +44 (01245) 453616
Fax: +44 (01245) 453410
E-mail: neil.bar...@e2vtechnologies.com


 -Original Message-
 From: Mark Schmidt [mailto:mschm...@xrite.com]
 Sent: 18 September 2002 13:11
 To: emc-p...@majordomo.ieee.org
 Subject: Distributors of Medical Devices in Europe
 
 
 
 Hello Group,
 
 Are there any requirements for European Distributors of 
 Medical Devices, i.e. license or registration. The Device in 
 question is a Class 1 device.
 
 Thank you.
 
 Mark Schmidt
 Regulatory Compliance 
 X-Rite Incorporated 
 Grandville, MI 
 USA
 (616) 257 2469
 mschm...@xrite.com
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Re: Distributors of Medical Devices in Europe

[jgriver]

Mark,

I assume that you mean Class 1 according to the EU's Medical Devices 
Directive, and not the FDA classification. Although the principle is 
the same, i.e. Class 1 is low-risk, the classification method is not 
identical.

The MDD deals with the device rather than the distributor. Compliance 
of the device with the MDD is mandatory. You should probably check 
the Health Ministry or 'Competant Authority' (as defined in the MDD), 
to check whether there are requirements on the distributor. As this 
subject is not covered by the MDD, the regulations are likely to be 
different in each country of the EU. You can contact the UK Competent 
Authority via their website at:

http://www.medical-devices.gov.uk/

Distributors would certainly be obligated to report incidents 
involving injury or death to the authorities.

I hope this helps.


Jon Griver
http://www.601help.com
The Medical Device Developer's Guide to IEC 60601-1



On 18 Sep 2002 at 8:11, Mark Schmidt wrote:

 
 Hello Group,
 
 Are there any requirements for European Distributors of Medical Devices, i.e. 
 license or registration. The Device in question is a Class 1 device.
 
 Thank you.
 
 Mark Schmidt
 Regulatory Compliance 
 X-Rite Incorporated 
 Grandville, MI 
 USA
 (616) 257 2469
 mschm...@xrite.com
 
 
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Distributors of Medical Devices in Europe

[Mark Schmidt]

Hello Group,

Are there any requirements for European Distributors of Medical Devices, i.e. 
license or registration. The Device in question is a Class 1 device.

Thank you.

Mark Schmidt
Regulatory Compliance 
X-Rite Incorporated 
Grandville, MI 
USA
(616) 257 2469
mschm...@xrite.com


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(Fwd) Medical devices, current limit

[jgriver]

Kim,

This type of product may be covered by IEC 60601-2-10, PARTICULAR REQUIREMENTS 
FOR THE SAFETY OF NERVE AND 
MUSCLE STIMULATORS, 
or possibly, IEC 60601-2-14, PARTICULAR REQUIREMENTS FOR THE SAFETY OF 
ELECTROCONVULSIVE THERAPY 
EQUIPMENT 

I don't have a copy of these standards, but they should relate to this issue.

With regard to a general discusion of this subject, have a look at the 
Rationale section (Appendix A) of IEC 60601-1. The rationale on 
sub-clause 19.3 gives information, a graph and references on this subject.

Regards,

Jon Griver
http://www.601help.com
THe Medical Device Developer's Guide to IEC 60601-1



--- Forwarded message follows ---
Hi all

I have a medical device under EU directive 93/42/EEC. It is a class IIa
product and sends some small electrical pulses through the body for
treatments.

Does anyone know of any limit for the current ? (voltage is generated
from battery and is max. 16Vdc)

Does anyone have the current/frequency diagram over max. current the the
body can withstand without hazards ? (It is normally used for mains
leakage current protection).


Best regards,

Kim Boll Jensen
Bolls Raadgivning
Denmark

--- End of forwarded message ---

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RE: Noise Levels for Household Appliances / Medical Devices

[Peter Merguerian]

John,

I am intersted in acoustic noise levels.


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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
http://www.itl.co.il
http://www.i-spec.com





-Original Message-
From: John Shinn [mailto:john.sh...@sanmina-sci.com]
Sent: Wednesday, August 14, 2002 6:53 PM
To: 'Peter Merguerian'; 'EMC-PSTC (E-mail) '
Subject: RE: Noise Levels for Household Appliances / Medical Devices


Are you talking electrical (EMC) noise or Acoustic?

John Shinn

-Original Message-
From: owner-emc-p...@majordomo.ieee.org
[mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of Peter Merguerian
Sent: Wednesday, August 14, 2002 3:09 AM
To: EMC-PSTC (E-mail) 
Subject: Noise Levels for Household Appliances / Medical Devices




Dear All,

Any recommended European or North American noise levels for household
appliances such as massagers? What are the applicable standards?

Any recommended European or North American noise levels for medical
equipment, such as massagers used by professionals in a therapy center? What
are the applicable standards?


This e-mail message may contain privileged or confidential information. If
you are not the intended recipient, you may not disclose, use, disseminate,
distribute, copy or rely upon this message or attachment in any way. If you
received this e-mail message in error, please return by forwarding the
message and its attachments to the sender.



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
http://www.itl.co.il
http://www.i-spec.com





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Medical devices, current limit

[Kim Boll Jensen]

Hi all

I have a medical device under EU directive 93/42/EEC. It is a class IIa
product and sends some small electrical pulses through the body for
treatments.

Does anyone know of any limit for the current ? (voltage is generated
from battery and is max. 16Vdc)

Does anyone have the current/frequency diagram over max. current the the
body can withstand without hazards ? (It is normally used for mains
leakage current protection).


Best regards,

Kim Boll Jensen
Bolls Raadgivning
Denmark
attachment: kimboll.vcf

Re: Noise Levels for Household Appliances / Medical Devices

[Nick Williams]

I don't think there are mandatory noise limits for these appliances, 
but directive 86/594/EEC says that if you do declare a noise value 
for an appliance, you have to use the right test methods and it has 
to be accurate.


Try looking for EN 60704 in the BSI on-line catalogue, and Statutory 
Instrument 1990:161 at www.hmso.gov.uk.


Rgds

Nick.



At 12:09 +0200 14/8/02, Peter Merguerian wrote:

Dear All,

Any recommended European or North American noise levels for household
appliances such as massagers? What are the applicable standards?

Any recommended European or North American noise levels for medical
equipment, such as massagers used by professionals in a therapy center? What
are the applicable standards?


This e-mail message may contain privileged or confidential information. If
you are not the intended recipient, you may not disclose, use, disseminate,
distribute, copy or rely upon this message or attachment in any way. If you
received this e-mail message in error, please return by forwarding the
message and its attachments to the sender.



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
http://www.itl.co.il
http://www.i-spec.com



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RE: Noise Levels for Household Appliances / Medical Devices

[John Shinn]

Are you talking electrical (EMC) noise or Acoustic?

John Shinn

-Original Message-
From: owner-emc-p...@majordomo.ieee.org
[mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of Peter Merguerian
Sent: Wednesday, August 14, 2002 3:09 AM
To: EMC-PSTC (E-mail) 
Subject: Noise Levels for Household Appliances / Medical Devices




Dear All,

Any recommended European or North American noise levels for household
appliances such as massagers? What are the applicable standards?

Any recommended European or North American noise levels for medical
equipment, such as massagers used by professionals in a therapy center? What
are the applicable standards?


This e-mail message may contain privileged or confidential information. If
you are not the intended recipient, you may not disclose, use, disseminate,
distribute, copy or rely upon this message or attachment in any way. If you
received this e-mail message in error, please return by forwarding the
message and its attachments to the sender.



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
http://www.itl.co.il
http://www.i-spec.com





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RE: Noise Levels for Household Appliances / Medical Devices

[Naftali Shani]

Peter, I don't have a clue to what levels we are exposed at home (never
measured) or what standard/s do apply, but for telecom equipment in North
America and Europe I have some references:

1. For Europe, ETS 300 753 (my version is from October 1997) uses  the range
of 5-5.5 bels for close proximity in an office environment - contact me
off-line for further details

2. In North America, Telcordia GR-63 uses the range of 60-65 dBA in a
'similar' environment


Regards,
Naftali Shani, Catena Networks (www.catena.com)
307 Legget Drive, Ottawa, Ontario, Canada K2K 3C8
613.599.6430/866.2CATENA (X.8277); C 295.7042; F 599.0445
E-mail: nsh...@catena.com


-Original Message-
From: Peter Merguerian [mailto:pmerguer...@itl.co.il]
Sent: Wednesday, August 14, 2002 6:09 AM
To: EMC-PSTC (E-mail) 
Subject: Noise Levels for Household Appliances / Medical Devices




Dear All,

Any recommended European or North American noise levels for household
appliances such as massagers? What are the applicable standards?

Any recommended European or North American noise levels for medical
equipment, such as massagers used by professionals in a therapy center? What
are the applicable standards?


This e-mail message may contain privileged or confidential information. If
you are not the intended recipient, you may not disclose, use, disseminate,
distribute, copy or rely upon this message or attachment in any way. If you
received this e-mail message in error, please return by forwarding the
message and its attachments to the sender.



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
http://www.itl.co.il
http://www.i-spec.com





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Noise Levels for Household Appliances / Medical Devices

[Peter Merguerian]

Dear All,

Any recommended European or North American noise levels for household
appliances such as massagers? What are the applicable standards?

Any recommended European or North American noise levels for medical
equipment, such as massagers used by professionals in a therapy center? What
are the applicable standards?


This e-mail message may contain privileged or confidential information. If
you are not the intended recipient, you may not disclose, use, disseminate,
distribute, copy or rely upon this message or attachment in any way. If you
received this e-mail message in error, please return by forwarding the
message and its attachments to the sender.



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
http://www.itl.co.il
http://www.i-spec.com





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RE: Medical Devices in Japan and Australia

[Kevin Richardson]

Mike,

For Australia, some of the standards you may wish to check include:

Safety - AS/NZS 3200.X.X suite of standards (Approval and Test
Specifications - Medical electrical equipment).  These are based on the IEC
601-X-X suite of standards.

EMC - AS/NZS 2064 (equivalent to CISPR 11 and EN55011)

Best regards,
Kevin Richardson

Stanimore Pty Limited
Compliance Advice  Solutions for Technology (including Australian Agent
Services)
(Legislation/Regulations/Standards)
Ph:   02-4329-4070   (Int'l: +61-2-4329-4070)
Fax:  02-4328-5639   (Int'l: +61-2-4328-5639)
Mobile:  04-1224-1620   (Int'l: +61-4-1224-1620)
Email:k...@compuserve.com
 (kevin.richard...@ieee.org - alternate email)

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immediately.



-Original Message-
From: owner-emc-p...@majordomo.ieee.org
[mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of Mike Cantwell
Sent: Friday, 25 January 2002 6:24 AM
To: emc-pstc (E-mail)
Subject: Medical Devices in Japan and Australia





Does anyone know:

1) Standards for medical devices in Japan and Australia?
2) Approval procedure for medical devices in Japan and Australia?

Any help/direction would be appreciated.

Thanks,

Mike Cantwell


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Medical Devices in Japan and Australia

[Mike Cantwell]

Does anyone know:

1) Standards for medical devices in Japan and Australia?
2) Approval procedure for medical devices in Japan and Australia?

Any help/direction would be appreciated.

Thanks,

Mike Cantwell


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RE: Medical devices in Asia

[Peter Tarver]

An excellent resource, John.  Thank you.

Regards,

Peter L. Tarver, PE
Product Safety Manager
Sanmina-SCI Homologation Services
peter.tar...@sanmina-sci.com

 -Original Message-
 From: Jon Griver
 Sent: Tuesday, January 22, 2002 9:59 PM

 Peter,

 An excellent place to start your search is:
 http://www.ita.doc.gov/td/mdequip/regulations.html

 which is the US Department of Commerce site,
 giving information on the
 medical device requirements for many countries.

 Good Luck

 Jon Griver
 www.601help.com
 The Medical Device Developer's Guide to IEC 60601-1
 
  All -
 
  I have been asked to look into medical device
 requirements
  in Asia.  This would include Pacific Rim and other Asian
  countries (the request was not specific,
 despite a little
  prodding).  I am only beginning my research and would
  appreciate any pointers you might be able to
 provide that
  will shorten the time it takes me in discovery.
 
  Thank you.
 
 
  Regards,
 
  Peter L. Tarver, PE
  Product Safety Manager
  Sanmina-SCI Homologation Services
  peter.tar...@sanmina-sci.com


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Re: Medical devices in Asia

[Jon Griver]

Peter,

An excellent place to start your search is:
http://www.ita.doc.gov/td/mdequip/regulations.html

which is the US Department of Commerce site, giving information on the
medical device requirements for many countries.

Good Luck

Jon Griver
www.601help.com
The Medical Device Developer's Guide to IEC 60601-1



 All -

 I have been asked to look into medical device requirements
 in Asia.  This would include Pacific Rim and other Asian
 countries (the request was not specific, despite a little
 prodding).  I am only beginning my research and would
 appreciate any pointers you might be able to provide that
 will shorten the time it takes me in discovery.

 Thank you.


 Regards,

 Peter L. Tarver, PE
 Product Safety Manager
 Sanmina-SCI Homologation Services
 peter.tar...@sanmina-sci.com


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Medical devices in Asia

[Peter Tarver]

All -

I have been asked to look into medical device requirements
in Asia.  This would include Pacific Rim and other Asian
countries (the request was not specific, despite a little
prodding).  I am only beginning my research and would
appreciate any pointers you might be able to provide that
will shorten the time it takes me in discovery.

Thank you.


Regards,

Peter L. Tarver, PE
Product Safety Manager
Sanmina-SCI Homologation Services
peter.tar...@sanmina-sci.com


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Re: Medical devices radiated immunity

[John Woodgate]

I read in !emc-pstc that Paolo Peruzzi paolo.peru...@esaote.com wrote
(in ofb1e46450.bdd89c4b-onc1256b1a.00494...@esaote.com) about 'Medical
devices radiated immunity', on Thu, 6 Dec 2001:

The second edition of IEC 60601-1-2 (EMC for medical electrical equipments)
sets out a radiated immunity test between 80 MHz and 2.5 GHz. For test
methods it refers to IEC 61000-4-3, which covers frequencies up to 2 GHz.
So what about the test method? Can you follow the procedure described in
Annex J of new 61000-3-4
61000-4-3
 ( FDIS version) as indipendent windows method up
to 2.5 GHz?

Not until the FDIS has passed its vote (closing date 2002-02-01), and
not in Europe until the new edition has been notified in the Official
Journal.

But since there is an obvious error in 60601-1-2, in calling up
61000-4-3 for measurements above 2 GHz, which it does not cover, I think
you can make a case in your technical file for using the method.
-- 
Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk 
After swimming across the Hellespont, I felt like a Hero. 

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Medical devices radiated immunity

[Paolo Peruzzi]

Hi all,

The second edition of IEC 60601-1-2 (EMC for medical electrical equipments)
sets out a radiated immunity test between 80 MHz and 2.5 GHz. For test
methods it refers to IEC 61000-4-3, which covers frequencies up to 2 GHz.
So what about the test method? Can you follow the procedure described in
Annex J of new 61000-3-4 ( FDIS version) as indipendent windows method up
to 2.5 GHz?

Thanks in advance,
p.

-
ESAOTE S.p.A. Paolo Peruzzi
Research  Product DevelopmentDesign Quality Control
Via di Caciolle,15tel:+39.055.4229306
I- 50127 Florence fax:+39.055.4223305
e-mail: paolo.peru...@esaote.com



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Medical Devices - another question

[emiguys]

So how does one break into the medical device field for a medical device 
manufacturer?  I was recently downsized and all of the compliance jobs in the 
Northeast seem to be for medical device manufacturers.  I have 15+ years of 
product safety, EMI, etc, but no medical device experience. Opinions 
appreciated.

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RE: Susceptibility level of medical devices (incubator) - urgent!

[Ned Devine]

Hi,

Per the FDA guidance on EMC http://www.fda.gov/cdrh/ode/638.pdf
The limit is 3 V/m.  See the page numbered 25 of the document.

Note:  This is for general medical equipment!  There is a guidance document
for incubators http://www.fda.gov/cdrh/ode/incubator.html
It references IEC 60601-2-19 and 2-20.  2-19 and 2-20 both require the unit
to pass at 3 V/m and to pass or fail safe at 10 V/m.  


Ned Devine
Program Manager III
Entela, Inc.
3033 Madison Ave. SE
Grand Rapids, MI  49548

616 248 9671 Phone
616 574 9752 Fax
ndev...@entela.com  e-mail






-Original Message-
From: Ralph Cameron [mailto:ral...@igs.net]
Sent: Monday, August 27, 2001 5:33 PM
To: Antonio Sarolic; emc-p...@majordomo.ieee.org
Subject: Re: Susceptibility level of medical devices (incubator) - urgent!



Antonio:

I would say many incubators were manufactured when there were no concerns
and the susceptibility was a function of the design and very variable. I
have heard they vary from 0.1V/m to 10V/m but don't think there is any set
standard. The medical gurus prefer to isolate their equipment by physical
barriers and hope that something will not affect them

In Canada Health Canada could answer thequestion . In the U.S. I believe its
the Food and Drug Administration.

Ralph Cameron
EMC Consulting and Suppression of Consumer Electronics
(After sale).


- Original Message -
From: Antonio Sarolic antonio.saro...@fer.hr
To: emc-p...@majordomo.ieee.org
Sent: Monday, August 27, 2001 11:59 AM
Subject: Susceptibility level of medical devices (incubator) - urgent!



 Hi

 I need urgent info on susceptibility level of medical electronic devices,
 especially baby incubators. Can anyone confirm if it is 1V/m (according to
 EU standards)? The EMI source is the GSM BS antenna (900MHz).

 Thanks very much.
 Antonio

 Antonio Sarolic, M.S.E.E.
 Faculty of Electrical Engineering and Computing
 Dept. of Radiocommunications and Microwave Engineering
 Unska 3, HR-1 Zagreb, CROATIA
 tel. +385 1 61 29 789, fax. +385 1 61 29 717
 E-mail: antonio.saro...@fer.hr




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Re: Susceptibility level of medical devices (incubator) - urgent!

[Ralph Cameron]

Antonio:

I would say many incubators were manufactured when there were no concerns
and the susceptibility was a function of the design and very variable. I
have heard they vary from 0.1V/m to 10V/m but don't think there is any set
standard. The medical gurus prefer to isolate their equipment by physical
barriers and hope that something will not affect them

In Canada Health Canada could answer thequestion . In the U.S. I believe its
the Food and Drug Administration.

Ralph Cameron
EMC Consulting and Suppression of Consumer Electronics
(After sale).


- Original Message -
From: Antonio Sarolic antonio.saro...@fer.hr
To: emc-p...@majordomo.ieee.org
Sent: Monday, August 27, 2001 11:59 AM
Subject: Susceptibility level of medical devices (incubator) - urgent!



 Hi

 I need urgent info on susceptibility level of medical electronic devices,
 especially baby incubators. Can anyone confirm if it is 1V/m (according to
 EU standards)? The EMI source is the GSM BS antenna (900MHz).

 Thanks very much.
 Antonio

 Antonio Sarolic, M.S.E.E.
 Faculty of Electrical Engineering and Computing
 Dept. of Radiocommunications and Microwave Engineering
 Unska 3, HR-1 Zagreb, CROATIA
 tel. +385 1 61 29 789, fax. +385 1 61 29 717
 E-mail: antonio.saro...@fer.hr




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Susceptibility level of medical devices (incubator) - urgent!

[Antonio Sarolic]

Hi

I need urgent info on susceptibility level of medical electronic devices,
especially baby incubators. Can anyone confirm if it is 1V/m (according to
EU standards)? The EMI source is the GSM BS antenna (900MHz).

Thanks very much.
Antonio

Antonio Sarolic, M.S.E.E.
Faculty of Electrical Engineering and Computing
Dept. of Radiocommunications and Microwave Engineering
Unska 3, HR-1 Zagreb, CROATIA
tel. +385 1 61 29 789, fax. +385 1 61 29 717
E-mail: antonio.saro...@fer.hr




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Re: Medical devices in Japan

[Nick Williams]

Thanks to everyone who replied on this thread. I've forwarded the 
responses to the original enquirer and doubtless they will contact 
anyone who offered further help as they feel appropriate.


Regards

Nick.




At 03:02 +0100 1/8/2001, Nick Williams wrote:
I've been asked if I know what the regime is for medical devices in 
Japan. I don't know anything about this, but if there's anyone out 
there who can give me a brief idea or possibly even some URLs to 
look at, I'd be grateful.


Anyone in the business of providing consultancy in this area please 
let me know and I'll likely put the enquirer in touch direct.


Thanks and regards

Nick.



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RE: Medical devices in Japan

[Mark Schmidt]

Hi Nick,

To assist you in determining the applicable standards you should contact
a representative from JAAME or MHLW at the following address:

Japan External Trade Organization (JETRO) New York
Health, Labor and Welfare Department
McGraw- Hill Building 44th Floor
1221 Avenue of the Americas
New York, New York 10020-1060
(212) 997 6471 or 212 997 6472
Fax 212 869 4750

This url doesn't have much info but here it is:

http://www.jaame.or.jp/english/index.html

Good luck, I wish I could be of more assistance.

Mark

 -Original Message-
From:   Nick Williams [mailto:nick.willi...@conformance.co.uk] 
Sent:   Tuesday, July 31, 2001 10:02 PM
To: emc-p...@majordomo.ieee.org
Subject:Medical devices in Japan


I've been asked if I know what the regime is for medical devices in 
Japan. I don't know anything about this, but if there's anyone out 
there who can give me a brief idea or possibly even some URLs to look 
at, I'd be grateful.

Anyone in the business of providing consultancy in this area please 
let me know and I'll likely put the enquirer in touch direct.

Thanks and regards

Nick.

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RE: Medical devices in Japan

[WOODS]

I too am not familiar with Japan, but I have a few tidbits to share.

JAMEI (Japan Association of Medical Equipment Industry)

Equipment appears to be approved under the leadership of the Ministry of 
Health and Welfare.


Richard Woods

--
From:  Nick Williams [SMTP:nick.willi...@conformance.co.uk]
Sent:  Tuesday, July 31, 2001 10:02 PM
To:  emc-p...@majordomo.ieee.org
Subject:  Medical devices in Japan


I've been asked if I know what the regime is for medical devices in 
Japan. I don't know anything about this, but if there's anyone out 
there who can give me a brief idea or possibly even some URLs to
look 
at, I'd be grateful.

Anyone in the business of providing consultancy in this area please 
let me know and I'll likely put the enquirer in touch direct.

Thanks and regards

Nick.

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RE: Medical devices in Japan

[Jim Conrad]

Nick,

I have a contact in Japan if you need it.  I do know that Japan just
approved the 2nd Edition of IEC 60601-1-2 but what I am not sure of is if
JTA requires compliance or what the transition date might be.  If you would
like me to look into this, contact me directly.

Best regards,

Jim

Jim Conrad
Conrad EMC Consulting
P.O. Box 25
Hamilton, MA 01936  USA

Phone:  978-468-3909
E-Mail:  jc...@shore.net


-Original Message-
From: owner-emc-p...@majordomo.ieee.org
[mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of Nick Williams
Sent: Tuesday, July 31, 2001 10:02 PM
To: emc-p...@majordomo.ieee.org
Subject: Medical devices in Japan


I've been asked if I know what the regime is for medical devices in
Japan. I don't know anything about this, but if there's anyone out
there who can give me a brief idea or possibly even some URLs to look
at, I'd be grateful.

Anyone in the business of providing consultancy in this area please
let me know and I'll likely put the enquirer in touch direct.

Thanks and regards

Nick.

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Medical devices in Japan

[Nick Williams]

I've been asked if I know what the regime is for medical devices in 
Japan. I don't know anything about this, but if there's anyone out 
there who can give me a brief idea or possibly even some URLs to look 
at, I'd be grateful.


Anyone in the business of providing consultancy in this area please 
let me know and I'll likely put the enquirer in touch direct.


Thanks and regards

Nick.

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RE: Serial Number Format - Medical Devices

[Ned Devine]

Hi Dick,

Section (e) deals with items that have an shelf life (i.e. sterile
products).  Having the actual month and year makes perfect sense.

Active devices usually are not date sensitive, except for usable lifetime
(i.e. 10 years) as defined by the manufacture.  The year of manufacture
only, needs to be on the label per 13.3.l.

It was my understanding that the actual year should be on the label.  Symbol
6.16 of ISO 15223 can be used or the year (i.e. 01) has to be an integral
part of the serial number.  If it was a code in the serial number, how would
the user know when the usable lifetime is up?


Ned Devine


Ned Devine
Program Manager III
Entela, Inc.
3033 Madison Ave. SE
Grand Rapids, MI  49548

616 248 9671 Phone
616 574 9752 Fax
ndev...@entela.com  e-mail

-Original Message-
From: Dick Grobner [mailto:dick.grob...@medgraph.com]
Sent: Monday, June 25, 2001 7:02 PM
To: IEEE EMC-PSTC E-Mail Forum (E-mail)
Subject: Serial Number Format - Medical Devices



A question to the group:
Referencing the Medical Device Directive, Annex I, paragraph 13.3 The label
must bear the following particulars: (l), year of manufacture for active
devices other than those covered by (e). This indication may be included in
the batch or serial number.   
One of my colleagues (in another company) was told by their Notified Body
(BSI) that it has been interpreted (by whom?) that this means the month and
year needs to be embedded into the actual serial number, such as XXZZ1
whereas XX: month and ZZ: year (or similar). 
We have never encountered this with our Notified Body (TUV). Our S/N's cross
back to a SN log which will reveal the month and year of manufacture.
Who is right? Does anyone know where this official interpitation is coming
from? The rational behind it?
Thank You
 
Dick Grobner
Medical Graphics Corporation
350 Oak Grove Parkway
St Paul MN 55127
651-766-3395
651-766-3389 (fax)
dick.grob...@medgraph.com



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Re: Serial Number Format - Medical Devices

[Nick Williams]

At 06:55 +0100 26/6/2001, John Woodgate wrote:

36BDBCA75E0FD411A80100104B93ABF202C2C24B@mgcmail, Dick Grobner
dick.grob...@medgraph.com inimitably wrote:

Referencing the Medical Device Directive, Annex I, paragraph 13.3 The label
must bear the following particulars: (l), year of manufacture for active
devices other than those covered by (e). This indication may be included in
the batch or serial number.  
One of my colleagues (in another company) was told by their Notified Body

(BSI) that it has been interpreted (by whom?) that this means the month and
year needs to be embedded into the actual serial number, such as XXZZ1
whereas XX: month and ZZ: year (or similar).
We have never encountered this with our Notified Body (TUV). Our S/N's cross
back to a SN log which will reveal the month and year of manufacture.
Who is right? Does anyone know where this official interpitation is coming
from? The rational behind it?


The words 'MAY be included in the serial number' do not mean 'SHALL be
included in the serial number'. I suspect that BSI Testing is being more
Royalist than the King.

BUT, I don't think that what you are doing is correct, either. The words
'must bear  year of manufacture' mean that the year must be stated
overtly, not just be deducible from your serial number records.
--



Dick,

I'd agree exactly with John on this. The directive requires the date 
to be in a legible form, and provides for the manufacturer to use the 
serial number as a way of doing this so that manufacturers who use a 
suitable serial number system do not have to put both date and serial 
number on if they don't want to. You may care to refer to EN1041:1998 
and specifically clause 4.1.10.


Rgds

Nick.

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Re: Serial Number Format - Medical Devices

[Doug McKean]

I'd say both are probably right.  I've never done medical.  But, I
have
run into this type of thing when I was doing ISO-9001 as a lead
auditor.

Critical words for interpretation are

 This indication may be included ... 

It specifically says *may* which means either *you can* or
*you don't have to* depending upon some circumstances.
In this instance, I do not know what those circumstances are.

It does not say shall which means *must do*.  The use of the
word *may* leaves it wide open to interpretation.  The use
of the word *shall* leaves no room for interpretation.  Thus,
the reason why I said both interpretations are probably right.

Now, an attempt to appeal their interpretation could be made.
But, if they are requiring others to do this, I doubt they'll back
down.

In any event, the requirement is to be able to trace from the label
of the device to the date of mfr for that device.

I suppose one could appeal in the case of:
1) a date was embedded in the serial number and
2) that date code was not of some obvious construction
(i.e. encoded/encrypted somehow),
then you'd have to look up the serial anyway.
Therefore, what's the need of a date code embedded in the serial
number when you have to look it up?

Also, the word indication may be interpreted any number of ways
also.

If you want to disect the wording, I'm sure it'll just get worse.

Regards, Doug McKean



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Re: Serial Number Format - Medical Devices

[John Woodgate]

36BDBCA75E0FD411A80100104B93ABF202C2C24B@mgcmail, Dick Grobner
dick.grob...@medgraph.com inimitably wrote:
Referencing the Medical Device Directive, Annex I, paragraph 13.3 The label
must bear the following particulars: (l), year of manufacture for active
devices other than those covered by (e). This indication may be included in
the batch or serial number.   
One of my colleagues (in another company) was told by their Notified Body
(BSI) that it has been interpreted (by whom?) that this means the month and
year needs to be embedded into the actual serial number, such as XXZZ1
whereas XX: month and ZZ: year (or similar). 
We have never encountered this with our Notified Body (TUV). Our S/N's cross
back to a SN log which will reveal the month and year of manufacture.
Who is right? Does anyone know where this official interpitation is coming
from? The rational behind it?

The words 'MAY be included in the serial number' do not mean 'SHALL be
included in the serial number'. I suspect that BSI Testing is being more
Royalist than the King.

BUT, I don't think that what you are doing is correct, either. The words
'must bear  year of manufacture' mean that the year must be stated
overtly, not just be deducible from your serial number records.
-- 
Regards, John Woodgate, OOO - Own Opinions Only. Phone +44 (0)1268 747839
Fax +44 (0)1268 777124. http://www.jmwa.demon.co.uk Why not call a vertically-
applied manulo-pedally-operated quasi-planar chernozem-penetrating and 
excavating implement a SPADE?

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RE: Production Line Test Requirements - Medical Devices

[Peter Merguerian]

Dear Jon, Dick and All Memebers,

I believe the UL method for Production-Line Grounding Continuity Test is
just to verify that someone did not forget to connect the earthing lead from
the appliance inlet or power corrd to the chassis. Therefore an ohmmeter,
buzzer or the like  is all that is considered necessary. The feeding of an
ac or dc current between the protective earth terminal and other parts of
the unit likely to be energized by a single insulation fault is not
necessary during the production-line tests because these tests have already
been conducted by the lab during the type tests. UL and other NRTLs want to
make sure that assembler did not forget to connect the main earthing lead. 

Also, if you check a UL or NRTL descriptive report used for the quarterly
folow-up inspections, you will note that the construction of the product has
been described in detail, including but not limited to earthing connections,
enclosure, covers, screws and washers, etc.  European test labs for
follow-up purposes, use a Critical Components List but do not describe the
construction of the product in detail. Hence, they require the  feeding on
an ac or dc low voltage current source into the earthing path for each
production unit.


Regards



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






-Original Message-
From: Jon Griver [mailto:jo...@medson.com]
Sent: Tuesday, May 22, 2001 9:06 AM
To: Dick Grobner
Cc: emc-p...@majordomo.ieee.org
Subject: RE: Production Line Test Requirements - Medical Devices



Dick,

This is the situation as I understand it. Please note that a few years ago I
did factory inspections for TUV Rheinland, so I'm speaking from a position
of some knowledge (though a bit outdated).

UL includes its production test requirements in its standards. It
traditionally has only required a check of earth continuity under low
current conditions.

The European test labs work on the basis of extracting production tests from
the standards. They require these tests to be performed as a condition of
using their mark on the product. It is the test lab's decision which
production tests are to be performed and it is not mandated by any standard.
Traditionally, the European test labs require the earth continuity test to
be carried out at high current conditions, as in the standard.

The logic behind this is that if there is a fault to earth, it will cause a
high current which may cause any weak links in the earth circuit to heat up
and possibly char and increase in resistance or even burn out completely.
(We've all seen charring around sockets). Thus this test is considered more
effective in identifying loose connections, etc. due to production mistakes
than the UL test, which might miss them.

Presumably if you are selling your medical product in the EU, you have a
Notified Body (unless your product is Group 1). You should agree your
production test plan with them. Be aware that they may insist on the high
current earth continuity test.

Good Luck,

Jon Griver
Medson Ltd


 -Original Message-
 From: Dick Grobner [mailto:dick.grob...@medgraph.com]
 Sent: Monday, May 21, 2001 18:23
 To: 'Jon Griver'
 Cc: IEEE EMC-PSTC E-Mail Forum (E-mail)
 Subject: RE: Production Line Test Requirements - Medical Devices


 Jon
 Thx for the info, however, I re-checked the two known US
 standards (UL2601,
 Appendix D - Manufacturer's Responsibilities, Construction Considerations
 and Requirements for Factory Tests) (NFPA 99, Grounding Circuit
 Continuity -
 Measurement of Resistance). UL defines Production Line Grounding
 Continuity
 Test Equipment as: Any suitable continuity indication device (such as an
 ohmmeter, a battery and buzzer combination, or the like) may be used to
 determine compliance with Grounding Continuity Test requirements. The NFPA
 std is even less definitive on this matter.
 EN60601-1, Appendix B - Testing During Manufacture and/or Installation,
 Not Used. See rational to sub-clause 4.1. Which states - Tests
 described in
 this standard are type tests.

 I checked all of the amendments including EN60601-1 for medical
 systems, and
 I do not see anything changing this.

 My questions remains, where does it state to use the 10-25Amp, 50
 or 60Hz @
 6Volt for 5 seconds test? Is this a carry over from another EN
 standard? Why
 wouldn't a simple continuity tests as defined by UL be appropriate from
 equipment coming off of the production line (assuring that the protective
 earth circuit in intake)?

 Appreciate your feedback Jon!  thanks again.

 Does anyone else on this forum have any input - would appreciate it.



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To cancel your

RE: Production Line Test Requirements - Medical Devices

[Jon Griver]

Dick,

This is the situation as I understand it. Please note that a few years ago I
did factory inspections for TUV Rheinland, so I'm speaking from a position
of some knowledge (though a bit outdated).

UL includes its production test requirements in its standards. It
traditionally has only required a check of earth continuity under low
current conditions.

The European test labs work on the basis of extracting production tests from
the standards. They require these tests to be performed as a condition of
using their mark on the product. It is the test lab's decision which
production tests are to be performed and it is not mandated by any standard.
Traditionally, the European test labs require the earth continuity test to
be carried out at high current conditions, as in the standard.

The logic behind this is that if there is a fault to earth, it will cause a
high current which may cause any weak links in the earth circuit to heat up
and possibly char and increase in resistance or even burn out completely.
(We've all seen charring around sockets). Thus this test is considered more
effective in identifying loose connections, etc. due to production mistakes
than the UL test, which might miss them.

Presumably if you are selling your medical product in the EU, you have a
Notified Body (unless your product is Group 1). You should agree your
production test plan with them. Be aware that they may insist on the high
current earth continuity test.

Good Luck,

Jon Griver
Medson Ltd


 -Original Message-
 From: Dick Grobner [mailto:dick.grob...@medgraph.com]
 Sent: Monday, May 21, 2001 18:23
 To: 'Jon Griver'
 Cc: IEEE EMC-PSTC E-Mail Forum (E-mail)
 Subject: RE: Production Line Test Requirements - Medical Devices


 Jon
 Thx for the info, however, I re-checked the two known US
 standards (UL2601,
 Appendix D - Manufacturer's Responsibilities, Construction Considerations
 and Requirements for Factory Tests) (NFPA 99, Grounding Circuit
 Continuity -
 Measurement of Resistance). UL defines Production Line Grounding
 Continuity
 Test Equipment as: Any suitable continuity indication device (such as an
 ohmmeter, a battery and buzzer combination, or the like) may be used to
 determine compliance with Grounding Continuity Test requirements. The NFPA
 std is even less definitive on this matter.
 EN60601-1, Appendix B - Testing During Manufacture and/or Installation,
 Not Used. See rational to sub-clause 4.1. Which states - Tests
 described in
 this standard are type tests.

 I checked all of the amendments including EN60601-1 for medical
 systems, and
 I do not see anything changing this.

 My questions remains, where does it state to use the 10-25Amp, 50
 or 60Hz @
 6Volt for 5 seconds test? Is this a carry over from another EN
 standard? Why
 wouldn't a simple continuity tests as defined by UL be appropriate from
 equipment coming off of the production line (assuring that the protective
 earth circuit in intake)?

 Appreciate your feedback Jon!  thanks again.

 Does anyone else on this forum have any input - would appreciate it.



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Re: Production Line Test Requirements - Medical Devices

[John Woodgate]

200105212113.oaa14...@epgc196.sdd.hp.com, Rich Nute ri...@sdd.hp.com
inimitably wrote:
Yes, for one strand.  No, for five strands.

I agree with what you say. In Europe, the PEC within equipment may be
16/0.2, so the possibility of the connection being reduced to one or two
strands is, in one sense, 1 in 560, while for your 36 strand wire it is
very much lower.
-- 
Regards, John Woodgate, OOO - Own Opinions Only. Phone +44 (0)1268 747839
Fax +44 (0)1268 777124. http://www.jmwa.demon.co.uk Why not call a vertically-
applied manulo-pedally-operated quasi-planar chernozem-penetrating and 
excavating implement a SPADE?

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Re: Production Line Test Requirements - Medical Devices

[Rich Nute]

Hi John:


   Because continuity at low current does not ensure that the protective
   circuit will carry a large fault current - it might be 'hanging on by
   one strand'.

Yes, for one strand.  No, for five strands.

Some years ago, I did some experiments on what
problems the 25-amp test would detect.  I 
simulated broken strands by cutting them one
at a time.  With five strands intact, the circuit 
passed the 25-amp, 2-minute test.  It failed at 
4 strands and 1 minute.

(The tested wire was 18 AWG comprised of 36 
strands of 34 AWG.)

The ability of a few strands to carry the 25-amp
current depends on the free length of the 
those few strands, which in turn determines the
heat-sinking provided to those strands.  The 
free length was on the order of 3 mm.  

My experiment assumed the problem was caused by 
an incorrectly set wire stripper, that cut a 
number of strands.  So there was a very small 
free length of strands.

I published this study in the Product Safety
Newsletter, Vol. 10, No.1, January-March, 1997.


Best regards,
Rich





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Re: Production Line Test Requirements - Medical Devices

[John Woodgate]

36BDBCA75E0FD411A80100104B93ABF202C2C079@MGCMAIL, Dick Grobner
dick.grob...@medgraph.com inimitably wrote:
Why
wouldn't a simple continuity tests as defined by UL be appropriate from
equipment coming off of the production line (assuring that the protective
earth circuit in intake)? 

Because continuity at low current does not ensure that the protective
circuit will carry a large fault current - it might be 'hanging on by
one strand'.
-- 
Regards, John Woodgate, OOO - Own Opinions Only. Phone +44 (0)1268 747839
Fax +44 (0)1268 777124. http://www.jmwa.demon.co.uk Why not call a vertically-
applied manulo-pedally-operated quasi-planar chernozem-penetrating and 
excavating implement a SPADE?

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RE: Production Line Test Requirements - Medical Devices

[Ned Devine]

Hi Dick,

The requirement for using 10 to 25 Amps comes from the test house.  It is
their mark.  If you want to use it, they can require you to do anything they
want.  Is it fair, no.  Does the requirement make engineering sense, no (I
believe that Rich Nute did an article on how this requirement did not
identify anymore failures than the simple ohm meter did).  Do you still have
to do it, yes!

If you are just declaring conformity for the MDD, use your risk analysis
(i.e. EN 1441) to show that the risk of using a ohm meter is an acceptable
one.  Your NB might review it, but you should be able to switch to the ohm
meter.

Ned


Ned Devine
Program Manager III
Entela, Inc.
3033 Madison Ave. SE
Grand Rapids, MI  49548

616 248 9671 Phone
616 574 9752 Fax
ndev...@entela.com  e-mail




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RE: Production Line Test Requirements - Medical Devices

[Dick Grobner]

Jon
Thx for the info, however, I re-checked the two known US standards (UL2601,
Appendix D - Manufacturer's Responsibilities, Construction Considerations
and Requirements for Factory Tests) (NFPA 99, Grounding Circuit Continuity -
Measurement of Resistance). UL defines Production Line Grounding Continuity
Test Equipment as: Any suitable continuity indication device (such as an
ohmmeter, a battery and buzzer combination, or the like) may be used to
determine compliance with Grounding Continuity Test requirements. The NFPA
std is even less definitive on this matter.
EN60601-1, Appendix B - Testing During Manufacture and/or Installation,
Not Used. See rational to sub-clause 4.1. Which states - Tests described in
this standard are type tests.

I checked all of the amendments including EN60601-1 for medical systems, and
I do not see anything changing this.

My questions remains, where does it state to use the 10-25Amp, 50 or 60Hz @
6Volt for 5 seconds test? Is this a carry over from another EN standard? Why
wouldn't a simple continuity tests as defined by UL be appropriate from
equipment coming off of the production line (assuring that the protective
earth circuit in intake)? 

Appreciate your feedback Jon!  thanks again.
 
Does anyone else on this forum have any input - would appreciate it.


-Original Message-
From: Jon Griver [mailto:jo...@medson.com]
Sent: Monday, May 21, 2001 9:16 AM
To: Dick Grobner
Subject: RE: Production Line Test Requirements - Medical Devices


Dick,

The requirements for production tests of medical equipment generally are:

1. Hipot at 1500AC - between live and neutral connected together and earth.
2. Earth continuity at 25A between earth pin on plug and enclosure (choose a
point that may be problematic if there are manufacturing problems)
3. Earth and/or patient leakage. Whether you do both, one or neither of
these tests depends on the product.

As the production tests are intended to find production problems (as opposed
to type tests which are intended to find design problems), choose the tests
that you think make sense from the production engineering point of view.
Document the reasoning behind your choice.

IT equipment only requires Hipot and earth continuity tests.

Hope this helps,


Jon


 -Original Message-
 From: Dick Grobner [mailto:dick.grob...@medgraph.com]
 Sent: Monday, May 21, 2001 16:36
 To: 'Jon Griver'
 Subject: RE: Production Line Test Requirements - Medical Devices


 Jon
 Thanks, you have confirmed what I thought I knew. We just had our
 annual ISO
 9001 audit (2 weeks ago). One issue that one of the two auditors
 raised was
 why are you not doing the ground integrity test (25 Amp test) on 100% of
 your production units? I asked do you mean ground continuity
 (Ohm test) and
 he said no, the ground integrity test. That's when I started digging into
 the standards. UL (and the former ETL) states high potential and ground
 continuity tests on all production units. EN60601-1 states that all tests
 within this document are type tests. The auditor gave me no reference to
 any EN, etc. when I asked. So, I have a suspicion that this is
 his wish and
 not stated in any EN (at least that I know of so far). SO - I
 will continue
 to pursue with other outside sources (but not this one auditor!)
 Thanks for the reply back!
 PS - does ITE equipment require this test (ground integrity ((25
 Amp)) test?


 -Original Message-
 From: Jon Griver [mailto:jo...@medson.com]
 Sent: Sunday, May 20, 2001 1:34 AM
 To: emc-p...@majordomo.ieee.org
 Subject: FW: Production Line Test Requirements - Medical Devices



 Dick,

 To the best of my knowledge there is no EN standard or guidance on
 production tests for medical equipment (There is a standard, EN 50116, for
 IT equipment).
 Your best bet is to discuss this with your Notified Body and to come to a
 mutually acceptable set of tests.

 Regards,

 Jon Griver
 Medson Ltd.


  Good Day Everyone
  Question I have - Does anyone out there know if an EN standard
 or guidance
  document exists that deals with production line test requirements of
  finished medical devices.
  Reading in EN60601-1 it states that the test (ground resistance, high
  potential, etc.) are type test only (See appendix B, and then paragraph
  4.1). Thus - they are not identified as production line tests.
 I know that
  the NRTL's in the USA (UL/ETL) specifically call out what tests
 are to be
  performed after the production build of equipment.
  Any input would be appreciated.
  Thx
 
  Dick Grobner
  Medical Graphics Corporation
  350 Oak Grove Parkway
  St Paul MN 55127
  651-766-3395
  651-766-3389 (fax)
  dick.grob...@medgraph.com
 
 
 
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FW: Production Line Test Requirements - Medical Devices

[Jon Griver]

Dick,

To the best of my knowledge there is no EN standard or guidance on
production tests for medical equipment (There is a standard, EN 50116, for
IT equipment).
Your best bet is to discuss this with your Notified Body and to come to a
mutually acceptable set of tests.

Regards,

Jon Griver
Medson Ltd.


 Good Day Everyone
 Question I have - Does anyone out there know if an EN standard or guidance
 document exists that deals with production line test requirements of
 finished medical devices.
 Reading in EN60601-1 it states that the test (ground resistance, high
 potential, etc.) are type test only (See appendix B, and then paragraph
 4.1). Thus - they are not identified as production line tests. I know that
 the NRTL's in the USA (UL/ETL) specifically call out what tests are to be
 performed after the production build of equipment.
 Any input would be appreciated.
 Thx

 Dick Grobner
 Medical Graphics Corporation
 350 Oak Grove Parkway
 St Paul MN 55127
 651-766-3395
 651-766-3389 (fax)
 dick.grob...@medgraph.com



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Production Line Test Requirements - Medical Devices

[Dick Grobner]

Good Day Everyone
Question I have - Does anyone out there know if an EN standard or guidance
document exists that deals with production line test requirements of
finished medical devices.
Reading in EN60601-1 it states that the test (ground resistance, high
potential, etc.) are type test only (See appendix B, and then paragraph
4.1). Thus - they are not identified as production line tests. I know that
the NRTL's in the USA (UL/ETL) specifically call out what tests are to be
performed after the production build of equipment.
Any input would be appreciated.
Thx

Dick Grobner
Medical Graphics Corporation
350 Oak Grove Parkway
St Paul MN 55127
651-766-3395
651-766-3389 (fax)
dick.grob...@medgraph.com



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FW: Medical devices

[Dick Grobner]

The device will need CE, thus the typical route is a tech file and a DoC.
Refer to the Medical Device Directive (MDD) or the In-Vitro directive. From
the little info you provided I would guess the Medical Directive is the one.
Reading the scope of both should assist you in selecting the appropriate
directive. Annex I in the directive provides the essential requirements
you need to be compliant with. You also need to (first thing) classify your
device, article 9 of the MDD will assist here. Article 11 of the MDD
addresses conformity assessment procedure, this identifies which of the
other Annexes you may follow to  allow CE marking of the device. 
This is somewhat condensed, best advise - obtain the directives, read
through them (more than once is highly recommended) and comprehend the
contents.
Good Luck!
If you wish you can contact me directly with any other questions, I may have
the right answer! 

 

-Original Message-
From: k...@i-data.com [mailto:k...@i-data.com]
Sent: Wednesday, January 17, 2001 2:13 AM
To: emc-p...@majordomo.ieee.org
Subject: Medical devices



Hi all

Can some one give me links to information regarding EU Medical Devices
directive.

My problem is to define the requirement for the following situation:

A manufacturer is making an add-on device for another company's medical
device and the total equipment is CE approved without involving the
manufacturer. Now the manufacturer want to CE mark this add-on device and
sell it to other companies as a CE approved device still for medical
equipment.

What is the requirements for this manufacturer, they have never been into
CE markin before.

The equipment is used in laboratoriums to move small glases with different
materials for testing in another test device.

best regards,

Kim  Jensen



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FW: Medical devices

[Jon Griver]

Kim,

Check out
http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/re
flist.html

From that page you can get to both the In Vitro Diagnostic Medical Devices
Directive and the Medical Devices Directive, as well as the Harmonised
Standards for these Directives.

It sounds like your product falls under the In Vitro Diagnostic Directive,
but check the scope. As an accessory, your product still has to fully comply
with the directive.

Best Wishes,

Jon Griver
Medson Ltd.
VP Quality Assurance
email: jo...@medson.com



 Hi all

 Can some one give me links to information regarding EU Medical Devices
 directive.

 My problem is to define the requirement for the following situation:

 A manufacturer is making an add-on device for another company's medical
 device and the total equipment is CE approved without involving the
 manufacturer. Now the manufacturer want to CE mark this add-on device and
 sell it to other companies as a CE approved device still for medical
 equipment.

 What is the requirements for this manufacturer, they have never been into
 CE markin before.

 The equipment is used in laboratoriums to move small glases with different
 materials for testing in another test device.

 best regards,

 Kim  Jensen





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Medical devices

[KBJ]

Hi all

Can some one give me links to information regarding EU Medical Devices
directive.

My problem is to define the requirement for the following situation:

A manufacturer is making an add-on device for another company's medical
device and the total equipment is CE approved without involving the
manufacturer. Now the manufacturer want to CE mark this add-on device and
sell it to other companies as a CE approved device still for medical
equipment.

What is the requirements for this manufacturer, they have never been into
CE markin before.

The equipment is used in laboratoriums to move small glases with different
materials for testing in another test device.

best regards,

Kim  Jensen



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RE: EMC on Medical Devices?

[Jon Griver]

David,

1. For the EU, the EMC standard is EN 60601-1-2. This standard calls out
CISPR 11 for radiated emissions, and various obsolete IEC 801 standards for
immunity. In addition, check out Clause 36 of the particular safety standard
EN 60601-2-XX (if there is one) for your specific product type. For medical
equipment, EMC is considered a safety issue.

2. For the US, medical equipment is exempted from FCC Part 15. However
medical equipment which uses EM radiation (e.g. microwave therapy
equipment), and ultrasound equipment, is subject to FCC Part 18. In
addition, the FDA may require immunity testing, depending on the device
type, as part of the regulatory approval process.

3. I do not know the situation for Asia Pacific. It is likely that the
technical requirements will not be different from the EU and US. However,
the regulatory process of demonstrating compliance may differ from country
to country.

Hope this helps.

Jon Griver
Medson Ltd.
VP Quality Assurance


 Subject: EMC on Medical Devices?

 Looking for a list of standards that apply to EMC on medical
 devices and the
 markets which they apply ( EU, US,  and Asia Pacific).

 Thanks

 Regards,

 David Spencer




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EMC on Medical Devices?

[Spencer, David H]

Looking for a list of standards that apply to EMC on medical devices and the
markets which they apply ( EU, US,  and Asia Pacific).

Thanks

Regards,

David Spencer

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RE: EMC for medical devices

[Brent DeWitt]

To further clarify:

IEC 60601-1-2 is the EMC requirements.  For reference, the CDV of the second
edition has just been sent to the full committee for voting.  If all goes
well, we will see it become official this calendar year.

Best regards,

Brent DeWitt
Datex-Ohmeda
IEC SC62A WG-13 member

 -Original Message-
 From: owner-emc-p...@ieee.org [mailto:owner-emc-p...@ieee.org]On Behalf
 Of Chris Duprés
 Sent: Wednesday, January 26, 2000 3:51 PM
 To: Kevin Newland
 Cc: emc-pstc
 Subject: EMC for medical devices



 Hi Kevin.

 You asked:
 1-What are the immunity standards used in Europe for medical devices? 

 I think you'll find that the IEC601 covers all the EMC requirements as
 well.
 Sorry, can't help with US requirements.

 Chris Dupres
 Surrey, UK.

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EMC for medical devices

[Chris Duprés]

Hi Kevin.

You asked:
1-What are the immunity standards used in Europe for medical devices? 

I think you'll find that the IEC601 covers all the EMC requirements as
well.
Sorry, can't help with US requirements.

Chris Dupres
Surrey, UK.

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FW: EMC for medical devices

[Dick Grobner]

-Original Message-
From: Dick Grobner 
Sent: Wednesday, January 26, 2000 11:19 AM
To: 'Kevin Newland'
Subject: RE: EMC for medical devices


Europe is EN 60601-1-2
In 1996 - for the US - it was the FDA's draft document entitled Reviewers
Guidance for Premarket Notification Submissions which was in line with the
requirements of 60601-1-2. However it does include a few additional immunity
tests which we have successfully waved with the FDA on past submissions. I'm
not aware of any other US requirements regarding EMC  medical equip.
 
-Original Message-
From: Kevin Newland [mailto:kevin_newl...@yahoo.com]
Sent: Tuesday, January 25, 2000 4:09 PM
To: emc-p...@majordomo.ieee.org
Subject: EMC for medical devices



Hello All,

Could someone let me know the answer to the following
questions please:

1-What are the immunity standards used in Europe for
medical devices? 

2-What EMC standards is used in US/Canada for medical
devices? 

The product in question is approved for safety to
IEC601-1.

Thank you
Kevin
__
Do You Yahoo!?
Talk to your friends online with Yahoo! Messenger.
http://im.yahoo.com

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EMC for medical devices

[Kevin Newland]

Hello All,

Could someone let me know the answer to the following
questions please:

1-What are the immunity standards used in Europe for
medical devices? 

2-What EMC standards is used in US/Canada for medical
devices? 

The product in question is approved for safety to
IEC601-1.

Thank you
Kevin
__
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Talk to your friends online with Yahoo! Messenger.
http://im.yahoo.com

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Medical devices lab in Italy

[DVVENTL Lizette de Vries-Vente]

Hi Everyone

I have a client that wishes to have a Class I medical device tested in 
Italy, since our own lab can not assist at present.

Can anybody suggest a lab or two that could possibly help for testing 
under the MDD ?

Thanks,
Lizette de Vries-Venter
SENIOR ENGINEER
Division of Electronics and Appliances
SABS

Tel : +27 12 428 6990
Fax : +27 12 428 6523
Email : dvve...@sabs.co.za


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Brazil approval of medical devices

[Massimo Polignano]

Does anybody out of there know which are the steps to be taken in order to
get the approval for a medical device to be sold in Brazil?

Do they recognize international standards as IEC 60601-1 and family?

What is the relevant law?

Which are the Notified Bodies for medical devices?

Thanks for any help.

m.p.

-
ESAOTE S.p.A.  Massimo Polignano
Research  Product Development Design Quality Control
Via di Caciolle,15 tel:+39.055.4229402
I- 50127 Florence  fax:+39.055.4223305
   e-mail: regr...@esaote.com



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RE: Medical Devices in Hyperbaric Chamber

[Douglas McKean]

At 12:16 PM 11/24/98 -0800, ed.pr...@cubic.com wrote:
Massimo:

Further complicating the issue is that the Apollo 1 fire ocurred with a
partial pressure O2 rich environment. My guess(!) is that a 1ATM O2 rich
environment would be even more hazardous.

Maybe you can find some hints on this via NASA or a hyperbaric chamber
manufacturer?

Just for the record, Apollo 1 had a pure O2 atmosphere. 
The disaster halted that practice.  And I believe medical 
oxygen tanks run about 40% O2.  I remember during dive 
training we were told medical O2 tanks weren't 100% O2. 


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Re: Medical Devices in Hyperbaric Chamber

[Patrick Lawler]

1) In a high-pressure atmosphere, convection cooling of power devices should be
OK.

2) Corona/voltage breakdown through the air would happen at a lower voltage
level.

These are based on the idea that there's little convection/corona in vacuum
environments.

As others have indicated, the gas in the chamber could play an important part
of the product safety as well.

--
Patrick Lawler
plaw...@west.net

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Medical Devices in Hyperbaric Chamber

[Massimo Polignano]

A distributors of ours asks us about the suitability of our ECG device for
use into a Hyperbaric Chamber.

Does anybody know any reference safety standard for medical devices in
hyperbaric chamber?
Are the environmental conditions similar to those in presence of a
flammable anaesthetic mixture with air or with oxygen or nitrous oxide
(IEC 601-1)?

Thanks for any help.

m.p.

---
ESAOTE S.p.A. Massimo Polignano
Research  Product Development   Regulatory Affairs
Via di Caciolle,15   tel:+39.055.4229402
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   e-mail: regr...@esaote.com



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RE: Medical Devices in Hyperbaric Chamber

[DAVE_OSBORN]

Hello Massimo,

The use of devices in oxygen enriched environments is not a trivial question.  
Many materials that are fire retardant at 21% O2 are highly combustible in 
enriched environments.If your product has not been specifically designed 
and evaluated for use in such environments, one would be taking a great risk in 
using them there.  Every year there are fires reported in hyperbaric chambers.  
Remember the Apollo One fire in 1967?

IEC 60601-1 (second edition) does not have appropriate requirements for oxygen 
enriched environments.  Work on the third edition is planned to address this 
issue.  

There is an excellent article on oxygen environments in the current issue of 
the ASTM Standardization News (November 1998) and the work of ASTM Committee 
G-4, Compatibility and Sensitivity of Materials in Oxygen-Enriched Atmospheres. 
 You can contact ASTM at http://www.astm.org


Best regards,
Dave Osborn
Hewlett-Packard Company
Medical Products Group
dosb...@hp.com
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-Original Message-
From: Non-HP-regrsfi /HP-ColSprings,mimegw3/dd.HPMEXT1=regr...@esaote.com 
Sent: Tuesday, November 24, 1998 3:24 AM
To: Non-HP-emc-pstc 
/HP-ColSprings,mimegw3/dd.HPMEXT1=emc-p...@majordomo.ieee.org
Cc: Non-HP-regrsfi /HP-ColSprings,mimegw3/dd.HPMEXT1=regr...@esaote.com
Subject: Medical Devices in Hyperbaric Chamber




A distributors of ours asks us about the suitability of our ECG device for
use into a Hyperbaric Chamber.

Does anybody know any reference safety standard for medical devices in
hyperbaric chamber?
Are the environmental conditions similar to those in presence of a
flammable anaesthetic mixture with air or with oxygen or nitrous oxide
(IEC 601-1)?

Thanks for any help.

m.p.

---
ESAOTE S.p.A. Massimo Polignano
Research  Product Development   Regulatory Affairs
Via di Caciolle,15   tel:+39.055.4229402
I- 50127 Florencefax:+39.055.4223305
   e-mail: regr...@esaote.com



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  File: Medical Devices in Hyperbaric Chamber.TXT  

RE: Medical Devices in Hyperbaric Chamber

[ed . price]

Massimo:

Further complicating the issue is that the Apollo 1 fire ocurred with a partial 
pressure O2 rich environment. My guess(!) is that a 1ATM O2 rich environment 
would be even more hazardous.

Maybe you can find some hints on this via NASA or a hyperbaric chamber 
manufacturer?

Ed



  From: dave_osb...@hp-waltham-om3.om.hp.com
  Subject: RE: Medical Devices in Hyperbaric Chamber
  Date: Tue, 24 Nov 1998 11:13:10 -0500 
  To: regr...@esaote.com
  Cc: emc-p...@ieee.org


 Hello Massimo,
 
 The use of devices in oxygen enriched environments is not a trivial question. 
  
 Many materials that are fire retardant at 21% O2 are highly combustible in 
 enriched environments.If your product has not been specifically designed 
 and evaluated for use in such environments, one would be taking a great risk 
 in 
 using them there.  Every year there are fires reported in hyperbaric 
 chambers.  
 Remember the Apollo One fire in 1967?
 
 IEC 60601-1 (second edition) does not have appropriate requirements for 
 oxygen 
 enriched environments.  Work on the third edition is planned to address this 
 issue.  
 
 There is an excellent article on oxygen environments in the current issue of 
 the ASTM Standardization News (November 1998) and the work of ASTM Committee 
 G-4, Compatibility and Sensitivity of Materials in Oxygen-Enriched 
 Atmospheres. 
  You can contact ASTM at http://www.astm.org
 
 
 Best regards,
 Dave Osborn
 Hewlett-Packard Company
 Medical Products Group
 dosb...@hp.com

--
Ed Price
ed.pr...@cubic.com
Electromagnetic Compatibility Lab
Cubic Defense Systems
San Diego, CA.  USA
619-505-2780
List-Post: emc-pstc@listserv.ieee.org
Date: 11/24/1998
Time: 12:16:35
--



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