Specifications

Safety
3
Your
Compliance
Responsibilities
A “purchaser” is the end user, or one who receives the product for
purposes other than resale. If you have purchased the laser to inte-
grate into a system, it is important to note that a given manufacturer
and a given purchaser may be part of the same company. This can
occur when the product is subject to interstate commerce, or when it
can be shown that one entity has the “manufacturer’s” role and the
other the “purchaser’s” role; also inter-division transfer pricing may
be considered “for value”). It’s especially important to note these
requirements when dealing with a foreign subsidiary, parent or divi-
sion bringing laser products into the U.S.
The text of the Federal Law is available from the Government
printing office as well as directly through the Office of the Center for
Devices and Radiological Health. There are also guideline docu-
ments and “A Guide To Preparing Product Reports For Lasers And
Products Containing Lasers” (dated September 1995). You may
request this material from:
U.S. Department of Health and Human Services
Public Health Service, Food and Drug Administration
Center for Devices and Radiological Health
Division of Small Manufacturers’ Assistance
Rockville, Maryland 20857
www.fda.gov/cdrh
[phone]
Material
Processing
Lasers
Coherent Diamond lasers are predominantly used in material
processing applications (operations in which there is sufficient laser
energy to cause a phase change in the incident material). An impor-
tant resource standard for integrating laser processing machines is
American National Standards Institute (ANSI) B11.21.
The ANSI B11.21 Standard encompasses the appropriate design,
construction, care and use of laser processing machines, and
includes references to other requirements, such as electrical
construction, noise, vibration and mechanical hazards, and so on.
The B11.21 also contains the appropriate references to ANSI Z
136.1, which is the User standard for laser radiation safety (used as
a basis for OSHA compliance).
You can obtain the ANSI B11.21 information from:
Association for Manufacturing Technology
7901 Westpark Drive
McLean VA 22102
www.mfgtech.org