OSHA Hazard Information Bulletins
Laser Systems.
 OSHA Safety and Health Information Bulletins - Table of Contents
- Information Date: 19880429
- Record Type: Hazard Information Bulletin
- Subject: Laser Systems.
April 29, 1988
| MEMORANDUM FOR: |
REGIONAL ADMINISTRATORS |
| THRU: |
LEO CAREY
Director
Office of Field Programs
TOM SHEPICH
Director
Directorate of Compliance |
| FROM: |
EDWARD BAIER
Director
Directorate of Technical Support |
| SUBJECT: |
Hazard Information Bulletin on Laser Systems |
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:
a) Compliance with the FDA's Laser Products Performance Standards,
21 CFR 1040.10 and 1040.11.
b) Compliance with ANSI Z136.1-1986.
c) Ability of the direct laser beam or reflected beam to cause
injuries to the eyes and skin during use.
d) Associated hazards such as electrical, noise, fire, and health.
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.
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