The component is marked, "does not comply...?"
I haven't seen that one yet.
Regards,
Peter L. Tarver, PE
Product Safety Manager
Sanmina Homologation Services
peter.tar...@sanmina.com
> -Original Message-
> From: acar...@uk.xyratex.com [mailto:acar...@uk.xyratex.com]
> Sent: Wednesday,
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
I need to add the following to clarify my below statements regarding FDA
certification.
21CFR, Chapter I, Section 1002.1(b) allows exemption for components intended
for sale exclusively to other manufacturers for use in other products. The
implication is that, if the component might be sold throu
...@majordomo.ieee.org
Subject: Laser approval
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
We use a class 3B component laser in one of our products. It has a FDA
accession number as a component and bears a big label stating
"Does not comply with 21CFR Ch1, 1040.10(f). For use in a Class 1 system only"
So my advice is yes, FDA registration as a component is required. At the end
of the
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
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