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Each medical laser product shall comply with all of the applicable requirements of 1040.10 for laser products of its class. The FDA standard 21 CFR 1040.10 and 1040.11) requires a warning label on Class IIIa and IIIb products. Class IIIb products must also have a key switch and connector for remote interlock for safety. The products are also required to have identifying and certifying labels and instructions for safe use.[1]

State laws

Several states have registration requirements and annual registration fees for operators of Class IIIb lasers. Check with the Department of Health in your state for additional information.

The American National Standards Institute (ANSI) publishes standards for the Safe Use of Lasers2:

  • Z136.1 American National Standard for the Safe Use of Lasers: 2000
  • Z136.5 American National Standard for the Safe Use of Lasers in Educational Institutions: 2000
  • Z136.6 American National Standard for the Safe Use of Lasers Outdoors: 2000[2]

The ANSI standards contain procedures for avoiding exposure to laser light, designation of a Laser Safety Officer, training of operators, and the posting of warning signs in laser operating areas for Class IIIb lasers. People who operate Class IIIb lasers should be familiar with these standards to ensure the laser is used safely. In cases where a laser pointer is misused and results in an injury or alleged injury, authorities may refer to these standards as criteria for appropriate use and safety precautions.

Reference

  1. International Electrotechnical Commission (IEC) Standard 60825-1, Ed. 1.2: 2001-08
  2. ANSI Z136 standards are available from the Laser Institute of America (www.laserinstitute.org)

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