Hi, KB.

It is incorrect that IEC825 does not apply to components.  In the case of
components, the worst case emissions, based on power supply and any other
factors that affect output power/energy must be considered.

The FDA requirements in 21CFR requires all laser sources, devices or
products to be certified.

Regards,

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


> -----Original Message-----
> From: k...@i-data.com [mailto:k...@i-data.com]
> Sent: Tuesday, January 09, 2001 11:58 PM
> 
> Hi all,
> 
> I have been asked if a laser which will be sold as a 
> component will have to
> be FDA approved. IEC 825 does not include lasers which are 
> components, only
> end-user products.
> 
> I can't understand the FDA requirements concerning components.
> 
> The laser is a Class 3B laser
> 
> Please send me a clear simple answer, if anybody can.
> 
> K. B. Jensen
> 

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