Global laser/LED Product Safety Regulations

Europe and International laser/LED product safety regulations*: 

1. IEC 60825-1:1993+A1:1997+A2:2001 and IEC 60825-1:2007 and AS/NZS 2211.1, Safety of laser products. This is the base standard. All laser and LED (depending on the LED application) products must be tested, classified and brought in compliance with the base standard.

2. IEC 60825-2 (2004), Safety of optical fibre communication systems. This standard applies to completely installed, end to end optical networks, and, it also applies to optical network telecom servers, routers, amplifiers, and subassemblies sold separately. Both the base standard and this standard apply to this type of equipment.

3. IEC 60825-4:1997+A1:2002+A2:2003, Safety of laser guards. This standard applies to laser guards that enclose the process zone of laser processing machines and equipment. Products containing a laser or an LED that employs a laser guard that encloses the process zone must meet both the base standard and this standard.

4. IEC 60825-6(1999-07), Safety of products with optical sources, used exclusively for visible information transmission to human eye. Products containing a laser or an LED that are exclusively used for transmission of information to the human eye must meet both the base standard and this standard.

5. IEC 60825-7(2000-06), Safety of products emitting infrared optical radiation, exclusively for wireless "free air" data transmission and surveillance. Products containing an infrared laser or an LED that are exclusively used for wireless free air data transmission and surveillance must meet both the base standard
and this standard.

6. IEC 60825-12(2004-02), Safety of free space optical communication systems used for transmission of information. Products containing a laser or an LED that transmits information through free space must meet the base standard and this standard.

7. IEC 601-2-22(1995-11), Safety of diagnostic and therapeutic laser equipment. Medical equipment containing a laser or an LED used for diagnostic and therapeutic treatment must meet both the base standard and this standard.

8. IEC 62471 Ed. 1 and CIE S 009/E:2002, International Standard for Photobiological Safety for Lamps & Lamp Systems - General Requirements. This standard covers the evaluation and control of optical radiation hazards from all electrically powered sources of optical radiation such as LEDs, UV and IR lamps, lamp devices, etc.

United States laser product safety regulations:

1. US FDA 21Code of Federal Regulations Subchapter J - Radiological Health (21CFR). Products that contain a laser must be tested and classified to 21CFR. A Product Report must then be compiled detailing construction and performance compliance to 21CFR and filed with the US FDA Center for Devices and Radiological Health (CDRH). The CDRH will issue an Accession number to the product allowing the product to be introduced into US commerce.

2. US FDA CDRH Laser Notices. These are CDRH published bulletins to industry further clarifying 21CFR. They provide the CDRH’s position and interpretations of the 21CFR requirements.

3. ANSI Z136.1-2000, American National Standard for safe use of lasers. This standard is a guide for the safe use of stand alone lasers and products that incorporate a laser or lasers and the facility they are used in.

4. ANSI Z136.2-1997, American National Standard for safe use of optical fiber communication systems utilizing laser diodes and LED sources. This standard is a guide for the safe use of optical networks.

5. ANSI Z136.3-2005, American National Standard for safe use of lasers in health care facilities. This standard is a guide for the safe use of lasers for diagnostic and therapeutic uses in health care facilities.

6. ANSI Z136.4-2005, American National Standard Recommended Practice for Laser Safety Measurements for Hazard Evaluation. This recommended practice provides adequate, practical guidance for necessary measurement procedures used for classification and hazard evaluation of lasers. The information provided in this recommended practice is intended to assist users who are entrusted with the responsibility of conducting laser hazard evaluations to ensure that appropriate control measures are implemented.

7. ANSI Z136.5 – 2000, American National Standard for Safe Use of Lasers in Educational Institutions. This standard applies the requirements of the latest revision of the ANSI Z136.1 to the unique environments associated with educational institutions, including teaching laboratories, classrooms, and lecture halls, science fairs as well as projects, and science museums, when they incorporate lasers into their educational process.

8. ANSI Z136.6 – 2000, American National Standard for Safe Use of Lasers Outdoors. This standard provides guidance for the safe use of potentially hazardous laser and laser systems (0.18 µm to 1 mm), in an outdoor environment. It also provides guidance to control disabling glare from exposure to non-injurious levels of visible laser light, e.g., when it might interfere with sensitive or critical tasks, and guidance for the manufacturers of these open-beam laser systems. 

9. ASNI/IESNA RP-27.1-96, American National Standard for Photobiological Safety for Lamps & Lamp Systems - General Requirements. This standard covers the evaluation and control of optical radiation hazards from all electrically powered sources of optical radiation such as UV lamps, LED devices, etc.

Note: The ANSI laser standards are primarily user safety standards. Requirements for products are applicable to products that are not introduced into commerce. That is, products that are used by parties who manufacture them or modify commercial products for their own use. Otherwise the US FDA CDRH standard, 21CFR, has precedence as a legal requirement for laser products in the United States.

Canadian laser product safety regulations:

1. Radiation Emitting Devices Act Chapter R-1:2001(RED),  issued by Department of Justice Canada, An Act respecting the sale and importation of certain radiation emitting devices. This Act refers to both 21CFR and IEC 60825 as the prescribed regulations for the purpose of radiation protection to persons. Depending on the particular Canadian province and the Canadian authority having jurisdiction, either 21CFR or IEC 60825 compliance is required by Canada.

*Note: EN standards are the IEC standards adopted by the countries of the European community and each country may add various national deviations particular to their country. EN stands for "European Norm". Currently, there are no European national deviations to the IEC 60825, safety of laser products standard.

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