Dave,
I use laser's a lot and have not run into that problem with the
European stuff, at least from a US manufacturer's perspective. Of all of the
companies with which I have dealt all have reported to the , FDA and CDRH as
required, along with getting a TUV or VDE cert to the IEC 825/EN60825 stuff.
Two small companies have given me some grief on the UL portion. One, because
quite frankly they didn't' understand what they were submitting to UL, and
the second claiming that they didn't' need to because they have the IEC
certificates through TUV and their requirements are more stringent.
Unfortunately, UL doesn't accept the TUV marks for compliance of the
laser. Whether they should or not certainly is its own debate, but at the
moment they don't. The first vendor is fixing the problem after a little
foot stamping. The second vendor still isn't going to have the part
recognized because they are miffed about UL's non-acceptance of TUV stuff,
but they are sending UL the UL engineer doing my report the CDRH report. UL
can use that to qualify the laser for use in my product and they won't share
the contents of the report with me. That is to protect anything the
manufacturer feels is proprietary from getting out.
The problem is, if you want to use this same laser, you are going to
have to chase the vendor down and have him resend the report to your UL
engineer. (UL can't release anything out of my file to anyone).
Considering them manufacturer has already done the hard part,
preparation of the CDRH, I don't understand the reluctance on their part,
but that's up to them. If there were more than two vendors of what I need in
a laser they wouldn't be part of my equipment, and eventually they won't be.
You can search UL's database and find lots of vendors for class 1
laser's as a starting data point. Unfortunately, you can't go to a similar
pool of data for EN60825 - at least to my knowledge. If you hit HP or
Agilent's site you can find a fairly large database of already approved
lasers in lots of packages and wavelengths. Probably are others but this one
is done very well and easy to access. While I don't want to sound like a
shill for Agilent (but I can be bought for the price of a polo shirt if
they're listening) they just make this part of the job so easy and I wish
others would adopt the web based certificates.
Gary
-----Original Message-----
From: Dave Wilson [mailto:[email protected]]
Sent: Monday, November 20, 2000 5:01 PM
To: 'Kenneth McCormick'; [email protected]
Subject: RE: Lasers in ITE Equipment
We had to supply accession numbers for all of the lasers used in our
equipment and submit a copy of our FDA report to satisfy UL. For CB, we have
to provide certificates for each laser against EN60825 - this is more
difficult, as some European component manufacturers are self-declaring,
meaning a full assessment of the component is required.
Dave Wilson
-----Original Message-----
From: Kenneth McCormick [mailto:[email protected]]
Sent: Monday, November 20, 2000 3:08 PM
To: [email protected]
Subject: Lasers in ITE Equipment
I am working with a client who has posed a question that I am not sure that
I can accurately answer.
What are the NRTLs (and for that matter, other test laboratories) requiring
for Laser Certifications. Annex NAE of UL1950/CSA C22.2 No 950 is an
INFORMATIVE annex(and mentions the regultory requirements of a CDRH Report
in US and a REDR in Canada), however Clause 4.3.12 leads me to believe that
proof of compliance with these regulatory requirements is REQUIRED by the
standard. With EN60950, compliance with IEC825 is required by clause 4.3.12.
Are the certifying laboratories witholding certification until the
manufacturer can show compliance with the applicable requirements, or are
they simply stating that compliance with the applicable laser requirements
is the responsibility of the manufacturer? If they are holding
certification, what proof will typically meet their requirements? Will
documentation showing that the application has been submitted to the CDRH
suffice, or do they typically require the final reports and approval issued
by CDRH? What laser markings, if any, are these laboratories requiring in
their compliance reports?
Is anyone aware of some documents that summarize the requirements of the CFR
& IEC825?
Thank you in advance,
Kenneth
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