April 29, 1988
The purpose of this bulletin is to alert field compliance and consultation personnel to the importance of careful evaluation of laser systems, the environment in which the laser is used and the possible exposure of workers to laser radiation. OSHA's Nonionizing Radiation standard, 29 CFR 1926.54, provides general requirements for lasers used on construction sites and is not appropriate for other applications such as medical and industrial laser products.
Since 1960, the laser has found many applications in the engineering, biological, and industrial fields. To name a few, lasers have been used in communication, tracking and ranging systems, surveying, mechanical measurements, drilling, welding, neurosurgery and endobronchial surgeries, dentistry, and automotive industry. Lasers produce monochromatic high intensity light beams, frequently capable of causing significant eye damage and body burns.
The Food and Drug Administration (FDA) issued a performance standard in 1976 for all manufacturers of laser products (21 CFR 1040.10 and 11). The performance standard was issued under the authority of the Radiation Control for Health and Safety Act of 1968 to protect the public form the hazards associated with laser products. The standard requires that all laser products manufactured on or after August 2, 1976, be certified to comply with the FDA performance criteria. The manufacturer must demonstrate that the product is in compliance with the standard and the associated quality control program prior to certification or introduction into commerce by furnishing necessary reports and documentation to FDA, Center for Devices and Radiological Health. Also annual reports must be submitted which summarize the records required to be maintained. Further, 21 CFR 1010.2 requires that all manufacturers of laser products must have a certification label on the product stating either "Complies with 21 CFR Chapter I, Subchapter J" or "Complies with 21 CFR 1040.10 and 1040.11." FDA defines a "manufacturer" as any person or organization in the business of making, assembling, or importing laser products.
ANSI Z136.1-1986, "American National Standard for the Safe Use of Lasers" provides guidance for the qualitative and quantitative hazard evaluation, classification, and control of laser systems. Tables 5, 6 and 7 of ANSI Z136.1 provide maximum permissible exposure (MPE) limits for eyes and skin exposure to laser beams. These values are identical to the TLV's recommended by ACGIH for the same wave length and exposure time. Table 10 or ANSI Z 136.1 provides a concise summary of recommended engineering and administrative controls for different classes of laser devices.
A comprehensive evaluation of a laser system must include the following:
Control measure programs for limiting access to laser radiation must include the engineering controls required by ANSI and FDA. Administrative controls and personal protective equipment must also be considered to supplement engineering controls. additionally, the conditions under which the laser is used, the level of safety training of individuals using the lasers, results of medical surveillance, service and maintenance procedures, and other environmental factors are important considerations in determining the effectiveness of a safety control measure. Section 4 of ANSI Z136.1 addresses control measures necessary to reduce the probability of exposure to harmful laser radiation and other hazards associated with the operation of laser devices.
We recommend that evaluation of laser systems be conducted only by those who are trained in this area and are familiar with ANSI and FDA requirements. Requirements such as laser certification in accordance with FDA standards, assigning laser safety officers, proper classification of lasers, warning signs and labels, medical surveillance, administrative controls, engineering controls, and personal protective equipment shall be verified. Violations of ANSI Z136.1 standard may be cited under Section 5(a)(1) after consultation with the Regional Solicitor. If non-compliance with the FDA certification requirements is noted, pertinent information should b reported to the Laser Product Section of FDA at FTS 427-8228.
Please disseminate this information to Area Offices, State plan States and consultation projects.Back to Top
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