In the United States there 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.
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-136.1 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.
Under the requirements of the Federal Laser Product Performance Standard: Title
21 of the Code of Federal Regulations; Part 1000; [parts: 1040.10 and 1040.11],
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. Lasers and laser
systems received from manufacturers shall be classified and appropriately labeled
by the manufacturer. However, the classification may change whenever the laser
or laser system is modified to accomplish a given task.
It is the responsibility of the owner/operator of a laser to effect the classification
designation in cases where the laser or laser system classification is not provided
or where the class level has changed because of alterations to the laser or laser
system.
