Jeff

In response the second part of your question on who enforces EN60825
within Europe. If the laser device is used on a product that falls under
on of the CE (or New Approach Directives ) eg. The LVD. Then the
enforcement will be like any other CE marked goods. Which varies from
country to country, bt for the UK the CE mark is watched over by the
Depeartment of Trade and Industy and the The Office of Trading
Standards. 

Now complaice to a CE marking directive carries penalities ranging from
Finess, porduct recal and worst case upto 2 years jail time for the
person signing the DOC. The enforcement is made agaist the perosn, not
the company.

Starngely though, if your Laser porduct does not fall under a CE
directive, there is no piece of European legistation saying it needs to
meet EN60825, beyond the old Product Safety Directive (Which does not
require a CE mark).

In your case, if you are incororating an already CDRH registered Class 1
device into your product without alteration. Then you do not need to re
register your overall product. This is covered by a CDRH notice to the
laser industry No. 42.

Andrew Carson - Senior Compliance Engineer, Xyratex, UK

Phone: +44 (0)23 9249 6855 Fax: +44 (0)23 9249 6014


-----Original Message-----
From: Chris Maxwell [mailto:chris.maxw...@nettest.com] 
Sent: 12 March 2002 13:22
To: Collins, Jeffrey; emc-p...@ieee.org
Subject: RE: ( More) Laser Safety Questions


I believe that OSHA enforces the CDRH laser safety guidelines in the
workplace.  I'm not sure about consumer goods...Possibly the Consumer
Product Safety Commission?

Penalties for non-compliance would be the typical fines, recalls ...
handed out by OSHA or CPSC.

> -----Original Message-----
> From: Collins, Jeffrey [SMTP:jcoll...@ciena.com]
> Sent: Monday, March 11, 2002 10:32 PM
> To:   'emc-p...@ieee.org'
> Subject:      ( More)  Laser Safety Questions
> 
> 
> 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
> Sr. HW Engineering Manager 
> EMC/ NEBS/ Safety/ Reliability
> CIENA  Core Switching Division
> 10480 Ridgeview Court, Cupertino, CA. 95014
> (408) 366-4806, Fax (408) 366-4866
> jcoll...@ciena.com
> http://www.ciena.com
> 
> 
> 
> 
> 
> 
> 
> 
> 
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