UL takes it upon themselves to verify that the laser product they are
certifying complies with the applicable FDA requirements. This can be
anything from a simple check of the CDRH report to a complete evaluation and
measurements of the laser. I believe at least some of their offices have
the proper test equipment.
Generally, these laser transceivers in question are complete laser products
in themselves and are separately certified by their respective
manufacturer's. As long as the manufacturer gets UL Recognition also, you
should expect that UL has already verified FDA compliance, and thus in the
end product, the transceiver should be treated just like a CD ROM used in
PC. Of course if you have a non UL Recognized transceiver, they'll most
likely want to see the CDRH report.
Glenn
-----Original Message-----
From: [email protected] [mailto:[email protected]]
Sent: Tuesday, March 23, 1999 8:01 AM
To: [email protected]
Subject: Re: RE: FDA Reports for Laser Transceivers
In the past I have had my problems with UL and lasers.
The FDA does not measure laser energy. The CDRH (part of the
FDA) collects
reports of laser products from manufacturers. These reports
are 25 pages
long and filled with technical information about the
product. There are
usually a significant number of attachments to each report.
The CDRH
reviews these reports. If there are questions about
completeness or
accuracy, the CDRH will ask for further information. If they
have no
questions about the submitted data, the report is simply
filed for future
use. Each report is assigned an ACCESSION number. Also, CDRH
does not
evaluate laser systems or laser product with an eye toward
"product
safety" of the EN 60950 type, they only look at laser light
issues.
My question is, has UL added standards or other expertise
that they can
use to evaluate lasers, laser safety and accuracy of the
CDRH reports?
That was my question a decade ago and I see it comes to
light once again.
BTW, obtaining CDRH reports for any given laser product or
laser system is
best done by contacting the manufacturer. They are
interested in selling
their products and if that is a condition of the sale, they
will usually
comply. However, don't expect to get these reports on laser
diodes as a
component, only on laser systems or laser products.
>
Scott
[email protected]
[email protected] writes:
>Have the vendor send the letter of ascension or whatever
the FDA calls it
>directly to UL. If the vendor doesn't have it yet, be
prepared for a
>lengthy
>delay. The FDA isn't too quick about these things for
resource reasons, I
>suppose. UL has to have that information because they do
not have the
>equipment to measure the light intensity. They just accept
the FDA
>measurements.
> Having danced around this issue myself, and
understanding the number
>of vendors that typically can provide the laser and do have
the necessary
>agency stuff out of the way I routinely reject those lasers
that haven't
>completed the process. The ones that I have accepted I had
better need
>pretty badly.
> You didn't ask but the IEC-825 requirements and the
UL requirements
>are not fully aligned. I don't know what the difference is
but I know
>that I
>have trouble getting TUV to buy off on a laser than is just
recognized and
>not yet certified.
> Gary
>
> -----Original Message-----
> From: [email protected] [SMTP:[email protected]]
> Sent: Monday, March 22, 1999 12:15 PM
> To: EMC-PST
> Subject: FDA Reports for Laser Transceivers
>
> Dear All,
>
> Many of my ITE customers have usually up to six
alternate Class I
> laser transceivers which they can use in any one
product. Some of
> these are UL Recognized, others are not. In the
latter case, our
> client strives to get the FDA Reports prior to
submitting their
> products for a formal Listing investigation. UL then
reviews these
> FDA reports for completeness and accuracy and issues
their
> Listing.
>
> 1. It seems to take a very long time until my client
does finally
> succeed in getting the FDA Reports for the laser
transceivers.
> Does anyone know of any shortcut?
>
> 2. Does UL archive the unrecognized FDA laser
reports for use
> when products are submitted for Listing?
>
> Any help on the above will be much appreciated.
> PETER S. MERGUERIAN
> MANAGING DIRECTOR
> PRODUCT TESTING DIVISION
> I.T.L. (PRODUCT TESTING) LTD.
> HACHAROSHET 26, P.O.B. 211
> OR YEHUDA 60251, ISRAEL
>
> TEL: 972-3-5339022
> FAX: 972-3-5339019
> E-MAIL: [email protected]
> Visit our Website: http://www.itl.co.il
>
>
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