Laser Standards:
A. OVERVIEW OF STANDARDS:
In the United States the are four major activities concerned with
regulations regarding safety of laser systems. These organizations
are the American National Standards Institute (ANSI), the Center
for Devices and Radiological Health (CDRH), the Occupational Safety
and Health Administration (OSHA), and the various state governments.
ANSI is an organization for which expert volunteers participate
on committees to set industry consensus standards in various fields.
ANSI has provided the basis for numerous existing federal standards
as-well-as the more recent Suggested State Regulations for Lasers
(SSRL). The ANSI-Z-136.1 (1986) standard provides requirements
and recommendations for the safe use of lasers with which the
personnel who operate, maintain and service lasers must be familiar.
The CDRH is a regulatory bureau within the Federal Food and Drug
Administration of the Department of Human Services. It has been
chartered by Congress to standardize the manufacture of laser
products. The laser products manufactured after August 2, 1976
which have been entered into interstate commerce must comply with
these regulations.
In addition, CDRH also has the responsibility for enforcing compliance
with the Medical Devices Legislation. All medical laser manufacturers
must obtain either pre-market approval (PMA) or clearance (510K)
of their laser surgical devices through the CDRH. It should also
be noted that FDA sanctions the exploratory use of lasers for
specific procedures through a process known as an Investigational
Device Exemption (IDE). Approval of an IDE permits the limited
use of a laser expressly for the purpose of conducting an investigation
of the laser's "safety and effectiveness." Once an IDE
has been done and the CDRH clears the device, the manufacturer
may then actively market the laser for that specific medical/surgical
procedure.
Laser regulations within the various states vary considerably
from state to state and are generally concerned with the registration
of lasers and the licensing of operators and institutions. This
is summarized in Table IV-1. At present, physicians and medical
lasers generally are exempt from most state requirements.
The complexity of state laser regulations may change in the future
pending adoption by states of the "Suggested State Regulation
for Lasers" which is currently being promulgated by the Conference
of Radiation Control Program Directors.
The regulatory administration of the U.S. Department of Labor
with the responsibility of assuring a safe work place is vested
in the Occupational Safety and Health Administration (OSHA). At
this time, OSHA does not have an all encompassing and comprehensive
laser standard. There is an OSHA standard which covers the use
of lasers in the construction field only (29 CFR 1910).
However, there have been OSHA citations issued relative to lasers
using the authority vested under the "general duty clause"
of Public Law 91-596; the Occupational Safety and Health Act of
1970. In these cases, the OSHA inspectors have asked the employers
to revise their reportedly unsafe work-place using the recommendations
and requirements of such industry consensus standards as the ANSI
Z-136.1 Standard.
B. Background of Laser Standards:
The initial development of laser safety standards began during
the mid-1960's as new biological data was made available. Revisions
occurred and the various standards reached their present state
during the period of 1973-1986. In 1972 two primary group in the
United States were developing laser standards. One was a consensus
group of industry, university and governmental experts on lasers,
laser biological effects and safety, who developed standard Z-136.1
(1973) under the auspices of the American National Standards Institute
(ANSI) in New York City. This committee created the concept of
classifying lasers according to a scheme of graded risk of exposure
and risk of injury evolved.
Due to the large variety of lasers, difficulties of laser measurements,
and the complexities of laser hazard evaluation, the committee
felt that the scheme of not more than five classes of graded risk
would help laser users to determine hazards. If hazards were known,
then proper safety controls could be applied according to the
classification. The different control measures were also graded
according to this classification scheme. Hence, a user with a
high risk laser (Class IV) would follow more stringent control
measures than would apply to a low risk laser (Class II).
During this same period the Bureau of Radiological Health within
the Food and Drug Administration developed regulations limited
to performance requirements that apply to manufacturers. In 1982,
the Bureau of Radiological Health was merged with the Bureau of
Medical Devices and renamed the National Center of Devices and
Radiological Health (NCDRH). The name was shortened soon thereafter
to simply the Center of Devices and Radiological Health (CDRH).
In addition to lasers, the CDRH also has regulatory responsibility
for the Medical Devices Legislation.
The basic law under which gave the CDRH regulatory authority
over lasers was the Radiation Control for Health and Safety Act
of 1968 (PL-90-602). The act empowered the CDRH to set standards
of performance for electronic products that emitted radiation.
This is the same public law that applies to X-rays, ultrasonic
devices, microwave ovens, etc.
Most of the CDRH's regulations pertains to very specific applications
of a particular type of source of electromagnetic radiation. For
instance, they do not have a standard for all microwave devices,
but they do have a standard for microwave cooking ovens. Similarly,
they have specific standards for X-ray emission from your color
TV sets, X-ray emission from diagnostic X-ray units, etc.
In the case of lasers, however because of the precedent of the
ANSI approach (which included all possible laser applications),
the CDRH chose to try to adapt the basic concept of ANSI and formulate
a set of performance and labeling requirements based on a classification
scheme according to the level of laser radiation accessible during
operation.
This was obviously a bold approach to undertake for a large class
of products which were relatively new or unknown at the time that
the standard was written. It is, therefore, not surprising that
there have been some difficulties both in basic concepts and in
interpretation of the standard since many have evolved since the
standard was initially written. The standard has been amended
twice since its initial issuance.
To summarize then, the CDRH Laser Product Performance regulates
the manufacturer and the commercial laser products, not the user.
The standard does not contain specific design specifications,
but is a conceptual, performance standard which the designer of
laser product must consider. The intent is to insure laser product
safety from the manufacturer's standpoint only, as the CDRH does
not "regulate the user" of electronic products. In addition,
the CDRH laser standard applies to all laser products that are
sold or otherwise transferred to users.
The ANSI-Z-136 standard is "For the Safe Use of Lasers"
and is available for voluntary adoption by users of equipment.
Although the Z-136.1 Standard in not "a law" it has
had direct impact on all laser standards worldwide.
C. Standards Versus Reality:
When the potential hazard from any real product is considered,
there is always a distinction between the real hazard and that
which may be implied by the regulations and standards. The writers
of standards and regulations are always forced to make general
statements which will inevitably have exceptions. Complete accuracy
is often sacrificed for simplicity. For example, notwithstanding
the complexity of the CDRH regulations, the classification limits
still do not, in all cases, fit the reality of current biological
knowledge.
For example, corrections for repetitively pulsed lasers have
not been incorporated into the CDRH standard although this has
been a part of the ANSI and other international standards for
more than a decade.
This may be related to the elaborate requirements for the review
and comment revision process for CDRH regulation which is slow
and cumbersome or to the lack of sufficient biological data to
support the issue.
In contrast, the revision process for an ANSI Standard is considerably
less cumbersome, which is reflected in the fact that a massive
revision was adopted and published in 1976, only two years after
the original publication. A second massive revision was completed
in 1980 by the ANSI committee to correct previous difficulties,
particularly in organization as well as compatibility with the
CDRH standard. A third complete revision was finished in 1986
and led to the publication of the fourth edition (ANSI Z-136.1-1986)
in the early part of 1986. Work is now underway for major revisions
and a new edition for 1991-1992 period.
The CDRH laser standard has undergone only two minor revisions
since it was first released. Some changes were proposed in November,
1980 and finally approved in August, 1985 to become effective,
in most part, by September 1986.
At present, the manufacturer of a laser product is faced with
two concerns:
1. Assurance that the laser products that are manufactured are
indeed reasonably safe both from an ethical standpoint and also
to avoid legal liability.
2. The compliance requirements of the Federal Laser Product Performance
Standard.
To some extent, in certain cases, there is a third consideration.
The necessity to avoid unwarranted fear and concern by the user
about the safety of the product.
D. U.S. Federal Laser Product Performance Standard (FLPPS):
A requirement of compliance with U.S. regulations is required
by organizations/personnel involved in the design, fabrication
and manufacture of laser products. This is applicable to lasers
or laser systems to be sold by a company within or imported inside
the U.S. It can also apply in some cases when a laser or laser
system is transferred within a company for internal use within
the U.S.
The compliance procedure requires implementation of the procedures
and requirements as set forth in the U.S. Federal Laser Product
Performance Standard: Title 21 of the Code of Federal Regulations;
Part 1000; [parts: 1040.10 and 1040.11].
This also pertains to commercial laser products that are placed
into commerce by a company either directly, after modification,
and/or after being incorporated into a laser product.
The FLPPS regulates the manufacturer and the performance of the
product by specifying performance features:
Under the requirements of the FLPPS, the manufacturer is required
to classify the laser as either a Class I, Class II, Class IIA,
Class IIIA, Class IIIB or Class IV laser product certify by means
of a label on the product, and submit an initial report demonstrating
compliance with all requirements (performance features) of the
standard.
E. Reporting Guidelines (FLPPS):
The Compliance Guide for Laser Products, which is available from
CDRH, summarizes the requirements of the U.S. Federal Laser Product
Performance Standard which a Manufacturer should use to ensure
that the laser product complies with the CDRH regulations (performance
requirements, labeling, reporting, classification, etc.) The Compliance
Guide is available from The Center for Devices and Radiological
Health (CDRH), Food and Drug Administration (FDA).
This guide should also be consulted prior to the completion of
Initial, Model Change, or Annual Reports by personnel responsible
for these reports (product engineers, designers, developers, etc.)
An Initial or Model Change Report shall be prepared, for each
laser product or product family, by the responsible personnel
for the location which is manufacturing the product and submitted
to the FDA prior to introducing the laser product into commerce.
An Annual Report for all manufactured laser products is also
required by the FDA. All locations which manufacture lasers that
are introduced directly into commerce must report to FDA/CDRH
all lasers manufactured from July 1 of any year to June 30 of
the next.
top