CHAPTER 6 REGULATORY REQUIREMENTS
Introduction
The sections that follow describe the integration, documentation, and labeling requirements for Class 1 and
Class 2 laser products.
Required Documentation for Class 1 Laser Products
The documentation accompanying the end product should contain the following:
•
"Complies with 21CFR1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated
June 24, 2007. "
•
"EN60825-1:2007"
•
"IEC 60825-1 (Ed. 2.0)"
•
"Class 1 Laser devices are not considered to be hazardous when used for their intended purpose. The
following statement is required to comply with US and international regulations:
CAUTION
A label such as the one below should appear in the product documentation, depending on the end product.
Refer to the current applicable laser safety standards for the end product or specific requirements.
Example of Class 1 Laser Warning Label
Figure 6-1
Use of controls, adjustments or performance of procedures other than those specified herein may
result in hazardous laser light exposure.
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