laser safety
7
Synrad
Series 48Series 48
Series 48Series 48
Series 48 operator’s manual
Agency compliance
The Agency compliance section includes subsections:
■ Center for Devices and Radiological Health (CDRH) requirements
■ Federal Communications Commission (FCC) requirements
■ European Union (EU) requirements
SYNRAD lasers are designed, tested, and certified to comply with certain United States (U.S.) and
European Union (EU) regulations. These regulations impose product performance requirements related
to electromagnetic compatibility (EMC) and product safety characteristics for industrial, scientific, and
medical (ISM) equipment. The specific provisions to which systems containing Series 48 lasers must
comply are identified and described in the following paragraphs. Note that compliance to CDRH, FCC,
and EU requirements depends in part on the laser version selected – Keyswitch or OEM.
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 radiated emission
standards fall under the jurisdiction of the U.S. Federal Communications Commission (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, Inc. assumes no responsibility for the compli-
ance 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 processing system,
they do not meet all of the Standards for complete laser processing systems as specified by 21 CFR, Part
1040 or EN 60825-1. SYNRAD, Inc. assumes no responsibility for the compliance of the system into
which OEM laser products are integrated.
Center for Devices and Radiological
Health (CDRH) requirements
Keyswitch models
Series 48 Keyswitch model lasers comply with requirements for Class IV laser products imposed by the
Radiation Control for Health and Safety Act of 1968. Under this Act, the U.S. Food and Drug Adminis-
tration (FDA) issued a performance standard in the Code of Federal Regulations (CFR) for laser products.
This performance standard, (21 CFR, Subchapter J, Part 1040.10) was developed to protect public health
and safety by imposing requirements upon manufacturers of laser products to provide an indication of the
presence of laser radiation, to provide the user with certain means to control radiation, and to assure that
all personnel are adequately warned of potential hazards through the use of product labels and instruc-
tions.
Product features incorporated into the design of Series 48 lasers to comply with CDRH requirements are
integrated as panel controls or indicators, internal circuit elements, or input/output signal interfaces.
Specifically, these features include a keyswitch (Keyswitch versions), lase and laser ready indicators,
remote interlock for power on/off, a laser aperture shutter switch, and a five-second delay between power
on and lasing. Incorporation of certain features is dependent on the laser version (Keyswitch or OEM).
Table 1, Class IV safety features, indicates which features are available on Series 48 lasers, the type and
description of the feature, and if the feature is required by CDRH regulations.
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