Specifications

Diamond™ GEM, G, & K, Integrator’s Guide

SAFETY

General Laser

Safety

Requirements

The information presented in this section is provided to give the

System integrator some recommendations on safety requirements

when incorporating a laser into an end product. It is by no means

complete. The System integrator is responsible for insuring that their

system will meet all of the necessary safety regulations and require-

ments.

The manufacture of laser products is Federally regulated, in the U.S.

and the exportation of laser products into Europe also requires

conformance to new EC Directives, laws and standards.

All Laser Products are subject to regulation under the Radiation

Control for Health and Safety Act of 1968 (Public Law 90-602,

hereinafter “the Act”). The Regulations for the Administration and

Enforcement of the Act, Title 21 Code of Federal Regulation

(21 CFR), require adherence to the Federal Laser Performance Stan-

dard contained in 21 CFR §1040, as well as compliance to other

reporting, record keeping and administrative requirements

contained in 21 CFR Sub-chapter J.

System

Integrators

A “laser manufacturer” is anyone who supplies (or modifies) a laser

product. The definition of a laser product, as presented in 21 CFR

includes “. . . any manufactured product or assemblage of compo-

nents which constitutes, incorporates or is intended to incorporate a

laser or laser system. . .”

This means no matter what relative percentage of your product is

laser related, if the product is intended to incorporate a laser, it

becomes a laser product. A “manufacturer,” according to 21 CFR, is

“any person engaged in the business of manufacturing, assembling

or importing” of (the subject laser) electronic product.

Manufacturers have certain compliance responsibilities “before

entering commerce”. Commerce is defined, for the purpose of the

regulation, as any Interstate commerce and includes exchange “for

value” or as a prize or award. “Entering commerce” may include

shipping to a beta test site, a trade show, or even (in some circum-

stances) transferring the product to another part of the company.