Synrad 32-1 - Center for Devices and Radiological Health (CDRH) Requirements; Compliance

SYNRAD® 32-1 Operator’s Manual Version 2.2
21
Laser Safety
Compliance
Center for Devices and Radiological Health (CDRH) requirements.
Federal Communications Commission (FCC) requirements.
European Union (EU) requirements.
SYNRAD® lasers are designed, tested, and certied to comply with certain United States (U.S.)
and European Union (EU) regulations. These regulations impose product performance re-
quirements related to electromagnetic compatibility (EMC) and product safety characteristics
for industrial, scientic, and medical (ISM) equipment. The specic provisions to which sys-
tems containing 32-1 lasers must comply are identied and described in the following para-
graphs.
In the U.S., laser safety requirements are governed by the Center for Devices and Radiological
Health (CDRH) under the auspices of the U.S. Food and Drug Administration (FDA) while radi-
ated emission standards fall under the jurisdiction of the U.S. Federal Communications Com-
mission (FCC). Outside the U.S., laser safety and emissions are governed by European Union
(EU) Directives and Standards.
In the matter of CE-compliant laser products, SYNRAD assumes no responsibility for the
compliance of the system into which the product is integrated, other than to supply and/or
recommend laser components that are CE marked for compliance with applicable European
Union Directives.
Because OEM laser products are intended for incorporation as components in a laser pro-
cessing system, they do not meet all of the Standards for complete laser processing systems
as specied by 21 CFR, Part 1040 or EN 60825-1. SYNRAD assumes no responsibility for the
compliance of the system into which OEM laser products are integrated.
Center for Devices and Radiological
Health (CDRH) requirements
Product features incorporated into the design of 32-1 lasers to comply with CDRH require-
ments are integrated as panel controls or indicators, internal circuit elements, or input/output
signal interfaces. Specically, these features include a lase and laser ready indicators, remote
interlock for power on/o, a laser aperture shutter switch, and a ve-second delay between
power on and lasing. Incorporation of certain features is dependent on the laser version (Key-
switch or OEM). See the Class 4 safety features, located in the following table, that indicate
which features are available on 32-1 lasers, the type and description of the feature, and if the
feature is required by CDRH regulations.
OEM models
32-1 OEM lasers are OEM products intended for incorporation as components in laser process-
ing systems. As supplied by SYNRAD, these lasers do not meet the requirements of 21 CFR,
Subchapter J without additional safeguards. In the U.S., the Buyer of these OEM laser