Greetings Richard,
In (Sept) 1995 the FDA revised the " Guide for Preparing Annual Reports on
Safety Testing of Laser and Laser Light Show Products. And issued
amendments to the regulations.
For updated info, contact the FDA CDRH at (phone) 301-443-6597 or (Fax)
301-443-8818.
Their mailing address is:
Center for Devices and Radiological Health
Office of Compliance (HFZ-307)
ATTN: Electronics Product Reports
2098 Gaither Road
Rockville, MD 20850
The European standard for laser product safety is IEC 825-1, -2 1993.
The techincal requirements are virtually the same, however, IEC 825 covers
LED devices as well.
At the present time, self declaration is accepted. Some European
customers/resellers may require product certification to this standard by a
third party. I have used CSA's photonics laboratory in Toronto, Canada.
Feel free to give me a call if you have any further questions.
Sincerely,
George Sparacino - PSE
UB Networks
508-691-4635
Hello all,
Way back when, there was some discussion on laser products
classifications.
Right now, we are new to the use of lasers and their regulations. I have
some basic knowledge of the regulations, due to long ago testing of them,
and my gray matter is not what it used to be.
I would appreciate some assistance in the following:
1) Where do I get the latest copy of the CDRH report?
Name, contact, address, tel., etc.
2) Filing procedures. I suspect it will be in the CDRH report that must
be filled out. As I remember it, it was every year and I had to note the
vendors model name, quantity and what product we were using the laser
for.
3) Labeling format will be in 21 CFR section 1040????
4) Any European document detailing who tests the laser for proper
usage/application in a larger product, labeling requirements (multiple
language????)
Any addition information would be most appreciated, as it is sometimes
difficult to ask the right questions.
Richard Georgerian
Product Compliance Eng.
Exabyte
tel.: 303-417-7537 fax: 303-417-7829 e-mail: richa...@exabyte.com
