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
[email protected]


> -----Original Message-----
> From: [email protected] [mailto:[email protected]]
> 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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