Jeffery -

I have no answer to the enforcement question for the US, but
I suspect it's complaint and incident driven, as the EMC
regulations historically have been.

For NRTLs, the acceptance of previously certified Class I
lasers incorporated into other equipment is based on CDRH
Laser Notice 42, available as a part of all Laser Notices at

http://www.fda.gov/cdrh/radhlth/pdf/laspol01.pdf

Links to other useful information is available at

http://www.fda.gov/cdrh/radhlth/index.html


Regards,

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

> -----Original Message-----
> From: Collins, Jeffrey
> Sent: Monday, March 11, 2002 7:32 PM
>
> Hello Group,
>
> There was a lot of good dialog recently regarding
> laser safety. Thanks to
> all that participated!!!!
>
> Questions:
>
> Who enforces the FDA CDRH 1040.1 laser safety
> standards in the US?
>
> How is it enforced?
>
> What are the penalties for noncompliance?
>
> Who enforces the IEC or EN 60825 laser safety
> standards in Europe /
> Globally?
>
> How is it enforced?
>
> What are the penalties for noncompliance?
>
>
> My questions are stemming from the Class 1 or 1M
> laser safety requirements
> particularly in Telecom networks.
> Some NRTL's and CAB's do not require or do not
> enforce their clients doing a
> submittal ( To the FDA ) for installing these
> types of laser products in
> your equipment. Their decision was based on your
> company using a class 1
> laser that carries a current NRTL / CAB safety
> certification which was not
> modified from it's original design when installed
> into your products.
>
> Thanks in advance,
>
> Jeffrey Collins


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