My experience with labeling is as long as all the required information is
available you can use a single label.  In fact on my product I have two
labels the first indicates the opening with "AVOID EXPOSURE - Laser Light
Emitted From This Aperture".  The second has the IEC label information, FDA
information, model number, date code, address, and other useless
information.




-----Original Message-----
From: Davis, Mike [mailto:mda...@c-cor.net]
Sent: Wednesday, March 06, 2002 6:26 AM
To: 'Doug Mckean'; 'John Juhasz'; 'Mark Schmidt';
emc-p...@majordomo.ieee.org
Subject: RE: Laser Safety


I agree with Doug and with John but, I have the same question. And I will
add, Doug is speaking of the FDA-CDRH requirement for the US. But, to
ascertain what the European mode is, this requires a single-fault condition
for classification as described by John Juhasz. That, I understand. John, is
there a free downloadable copy of ANSI Z136.1 and .2 specs?

I have used the calculations to determine the classification of a laser
based on the no fault and a single fault mode. These lasers are operating in
a pulsed mode at a 50% duty cycle. I have attached a sample calculation of a
1310nmn and a 1550nm laser that I used to determine that the lasers either
do or do not fall within the Class 1 laser classification. Another
question...

Can the same label be used for FDA as for IEC? Has anyone had any feedback
or problems with laser labels that deviated from recommended markings by the
21 CFR or IEC 825-1?


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