COMPLIANCE
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Compliance
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Center for Devices and Radiological Health (CDRH) requirements.
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Federal Communications Commission (FCC) requirements.
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European Union (EU) requirements.
NOVANTA® 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 32-1 lasers must comply are
identified and described in the following paragraphs.
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, NOVANTA 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 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. NOVANTA 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 requirements are
integrated as panel controls or indicators, internal circuit elements, or input/output signal interfaces.
Specifically, these features include a 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). 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 processing systems.
As supplied by NOVANTA, 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 components is solely responsible for the
assurance that the laser processing system sold to an end user complies with all laser safety requirements
before the actual sale of the system. Under CDRH regulations, the Buyer must submit a report to the CDRH
prior to shipping the system. In jurisdictions outside the U.S., It is the sole responsibility of the OEM
Buyer/end-user to integrate the laser so that it complies with all applicable laser safety standards as set
forth above.
Summary of Contents for 32-1 Laser
Page 1: ...ENGINEERED BY SYNRAD 32 1 Laser User Manual...
Page 19: ...32 1 LABEL LOCATIONS PAGE 19 32 1 label locations Figure 2 3 38 1 Hazard label locations...
Page 25: ...ELECTROMAGNETIC INTERFERENCE STANDARDS PAGE 25 Figure 2 1 32 1 Declaration Document...
Page 26: ...ELECTROMAGNETIC INTERFERENCE STANDARDS PAGE 26 Figure 2 5 continued 32 1 Declaration Document...
Page 41: ...I O FAULT DIAGRAMS PAGE 41 I O Fault Diagrams Table 4 6 DB 9 pin assignments...
Page 57: ...INDEX PAGE 1...
