Chris,

As I recall Laser Notice 50 does not exempt you from the record keeping and
report of the CFR 21, only the qualification aspects.

Regards,
Josh


-----Original Message-----
From: Chris Maxwell [mailto:[email protected]]
Sent: Wednesday, June 19, 2002 1:24 PM
To: John Juhasz; Davis, Mike; Emc-Pstc (E-mail)
Subject: RE: Two Questions concerning the subject of Laser Safety 



As a follow up to John's reply below:

If you are considering taking some kind of class or hiring a consultant for
laser safety; you may want to consider buying a copy of the latest version
of EN 60825-1.  The standard is very thorough, providing methods to
determine the class of laser devices either by measurement or calculation.
It also has tables of requirements for labeling, manual information,
interlocking...requirements for different classes of lasers.

The good thing is, the CDRH has issued Laser Notice 50 which essentially
states that you can use EN 60825-1 to meet the technical aspects (laser
classification, labeling...) of the CDRH requirements.  This greatly
simplifies the technical aspects of laser compliance.  It also means that
your copy of EN 60825 will help you with foreign and US laser safety
compliance. 

Chris Maxwell | Design Engineer - Optical Division
email [email protected] | dir +1 315 266 5128 | fax +1 315 797 8024

NetTest | 6 Rhoads Drive, Utica, NY 13502 | USA
web www.nettest.com | tel +1 315 797 4449 | 



> -----Original Message-----
> From: John Juhasz [SMTP:[email protected]]
> Sent: Wednesday, June 19, 2002 12:57 PM
> To:   'Davis, Mike'; Emc-Pstc (E-mail)
> Subject:      RE: Two Questions concerning the subject of Laser Safety 
> 
> 
> Mike,
> 
> Go to the following link of the CDRH (Center for Devices and Radiological
> Health). They're the ones to whom the
> reports will be sent. There are further links to information that will be
> very useful to you and should answer most
> of the questions you posed below.
> 
> http://www.fda.gov/cdrh/radhlth/index.html
> 
> Simply put, at this moment in the US LEDs are not regulated. But the CDRH
> will be aligning the regs with Europe (EN 60825) where
> verification that the LEDs are safe is required.
> 
> GE Interlogix
> 
> John A. Juhasz
> 
> Fiber Options Div.
> Bohemia, NY 
> 
> 
> 
> 

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