Re: [PSES] Questions on GS, VDE and UL Recognized Marks

2017-01-18 Thread Richard Nute 
 

 

Dear all:

 

I apologize for my unkind characterization of VDE and UL.

 

Rich 

 

 

From: Richard Nute [mailto:ri...@ieee.org] 
Sent: Monday, January 02, 2017 10:49 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] Questions on GS, VDE and UL Recognized Marks

 

 

Hi Vincent:

 

I’m a cynic regarding certification houses such as VDE and UL.  Their primary 
motive is income in the name of safety (not necessarily actual safety).  

 

4) Does it mean that components that meet VDE Mark and meet UL Recognized Mark 
without much testing to be done? 

 

Example, a Li-ion battery which is IEC / EN 62133:2012 certified with VDE Mark, 
does it mean that it can meet UL Recognized Mark requirement with just little 
or no extra testing to be done?

 

With the advent of IECEE, members must recognize competitors’ certifications, 
which means little or no income from testing and certification.  Members do 
their best to find problems with others’ testing so that they can re-do the 
testing and derive some income.  National deviations from an IEC standard 
provide another opportunity to test and derive income (if the original CB 
report did not cover the national deviations).

 

So, the answer is, “it depends.”  If there is no CB report, then VDE and UL 
testing are independent of each other.  If there is a CB report, the other 
member will evaluate it and give you its finding whether the CB report meets 
the standard’s (their interpretation) requirements (and local, unwritten 
requirements of the test house).  (Providing a copy of the non-CB test report 
will probably make it easier for the other test house to test the unit and more 
timely, but probably will not make it less expensive.)  

 

Best wishes for the New Year,

Rich

 

 


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Re: [PSES] ISO 13485-2016

2017-01-18 Thread John Woodgate 
These OJ list updates are often long delayed. In fact, a 2016 standard might 
not yet have completed the endorsement process in CEN.
 
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.
 
From: Stephen Whalen [mailto:scwha...@bellsouth.net] 
Sent: Wednesday, January 18, 2017 3:17 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] ISO 13485-2016
 
All,
I am helping a client with medical device manufacturing QMS.  ISO 13485 - 2016 
has been released however 2016 version is not listed as harmonized with EU.  
Does anyone know if 2016 version is acceptable now for CE approval?
https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en
 
Regards,
Stephen
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Re: [PSES] ISO 13485-2016

2017-01-18 Thread Brian O'Connell 
All hail the Goddess of Search. March 2019 per

https://standards.cen.eu/dyn/www/fp=204:110:0FSP_PROJECT,FSP_ORG_ID:37957,581003=10ED77AEC2D379A0A511B4BB99F861487

Brian


From: Stephen Whalen [mailto:scwha...@bellsouth.net] 
Sent: Wednesday, January 18, 2017 7:17 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] ISO 13485-2016

All,
I am helping a client with medical device manufacturing QMS.  ISO 13485 - 2016 
has been released however 2016 version is not listed as harmonized with EU.  
Does anyone know if 2016 version is acceptable now for CE approval?
https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en

Regards,
Stephen

-

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Re: [PSES] ISO 13485-2016

2017-01-18 Thread Jon Griver 
Stephen,

 

At this stage, the version of ISO 13485 required for approval to the Medical 
Devices Directive is EN ISO 13485:2012. The body of this standard is identical 
to ISO 13485:2003, and there are some additional EU appendices.

 

I have heard from at least one Notified Body that they will not be accredited 
to audit to ISO 13485:2016 until the start of 2018, so at the moment you can't 
claim compliance to this standard alone.

 

However, the solution is quite simple. You prepare the quality manual and 
procedures to ISO 13485:2016 and operate the quality system according to its 
requirements. You also make sure that the quality system is also compliant with 
ISO 13485:2003 and EN ISO 13485:2012. That's shouldn't be difficult, as the 
differences are minor.

 

Then, in the scope section of the Quality Manual, you state that the quality 
system is intended to comply with ISO 13485:2003, EN ISO 13485:2012 and ISO 
13485:2016, together with whatever other regulatory requirements you need.

 

Regards,

 

Jon Griver

http://www.601help.com

The Medical Device Designer's Guide to IEC 60601-1

 

From: Stephen Whalen [mailto:scwha...@bellsouth.net] 
Sent: 18 January 2017 17:17
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] ISO 13485-2016

 

All,

I am helping a client with medical device manufacturing QMS.  ISO 13485 - 2016 
has been released however 2016 version is not listed as harmonized with EU.  

Does anyone know if 2016 version is acceptable now for CE approval?

https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en

 

Regards,

Stephen

-


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 >

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Re: [PSES] ISO 13485-2016

2017-01-18 Thread Brian O'Connell 
Forgot to say that, while the 2016 edition can be used now, accreditation and 
reports per 2016 edition dependent on your particular registrar update 
schedule, lunar phase, and planetary alignments relative to the Klingon 
Home-world.

https://standards.cen.eu/dyn/www/f?p=204:110:0FSP_PROJECT:37957=1B04E3A6EA841FF02235DCA86690F765D

Brian

-Original Message-
From: Brian O'Connell 
Sent: Wednesday, January 18, 2017 8:27 AM
To: 'Stephen Whalen'; EMC-PSTC@LISTSERV.IEEE.ORG
Subject: RE: [PSES] ISO 13485-2016

All hail the Goddess of Search. March 2019 per

https://standards.cen.eu/dyn/www/fp=204:110:0FSP_PROJECT,FSP_ORG_ID:37957,581003=10ED77AEC2D379A0A511B4BB99F861487

Brian


From: Stephen Whalen [mailto:scwha...@bellsouth.net] 
Sent: Wednesday, January 18, 2017 7:17 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] ISO 13485-2016

All,
I am helping a client with medical device manufacturing QMS.  ISO 13485 - 2016 
has been released however 2016 version is not listed as harmonized with EU.  
Does anyone know if 2016 version is acceptable now for CE approval?
https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en

Regards,
Stephen

-

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[PSES] ISO 13485-2016

2017-01-18 Thread Stephen Whalen 
 All,I am helping a client with medical device manufacturing QMS.  ISO 13485 - 
2016 has been released however 2016 version is not listed as harmonized with 
EU.  Does anyone know if 2016 version is acceptable now for CE 
approval?https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en
Regards,Stephen

-

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