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;
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:
Protective housing warning labels and logotype labels
Remote interlock connector
Specification on control locations
Viewing optic limitations
Scanning beam safeguards
Manual reset on beam cutoff
The laser manufacturer establishes the required specifications, and is responsible for compliance with federal CDRH laser product requirements. The laser product will encompass one of the following categories:
Internally developed by a organization within a company.
Obtained from an organization within a company.
Obtained from an outside manufacturer and repackaged for resale.
Obtained from an outside manufacturer, incorporated into another product and repackaged for resale.
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.
Guidelines for Laser Safety and Hazard Assessment
Source: Occupational Safety & Health Administration, Guidelines for Laser Safety and Hazard Assessment PUB 8-1.7 (tablular data and equation illustrations have been omitted).