The Federal Laser Products Performance Standard became effective on August 2, 1976. The standard affords users of laser products safety from radiation exposure through containment of the radiation or through indication of graduated degrees of hazard from radiation that cannot be contained. To provide the graduated levels of hazards of radiation, the standard establishes four classes of product based on biological data. A greater number of safety features and warning labels are required according to the increasing classification assigned to products.

The Federal laser products performance standard requires that graduated degrees of protection be available based upon human access to the collateral and laser radiation produced by a product. Protective housings are required to preclude access to radiation whenever and wherever it is not required for the intended purpose of the product. If human access can not be reasonably prevented, then the safety related performance features and warning labels required by the standard depend upon the product classification. This classification is based on a graded risk of biological injury.

The Federal Performance Standards for Laser Products require that laser products incorporate means to provide warnings and control for laser radiation. The requirements are graded according to the levels of radiation and include protective housings, safety interlocks, remote control connector, key control, laser radiation emission indicator and beam attenuator. In addition, there are performance requirements that apply to the location of controls, viewing optics and scanning laser products. A brief explanation of the requirements is presented with a discussion of some of the general approaches taken by manufacturers in meeting the requirements and our reaction to these approaches.

The laser standard prescribes certain warning labels that must be attached to the product and certain radiation safety information that must be provided to the user, the potential buyer, and the service person to warn these people about the existence of hazardous levels of radiation associated with the laser product. This information is provided to permit persons working with the product to take the necessary protective measures to avoid hazardous radiation exposure. The individual requirements will be discussed in detail with some examples to clarify the rationale for each one. Some of the more commonly seen compliance errors will also be pointed out.

A basic understanding of FDA/BRH organization and administrative procedures can be of great value to those who must deal with the Bureau. In addition, the procedures whereby any manufacturer or interested party can petition the Bureau for advice, request a policy statement, suggest amendments to standards, request exemptions, variances and other procedures are also discussed.

Documenting conformance with Federal requirements and establishing test procedures and distribution records are a normal part of a manufacturing business. The purpose of this paper is to demonstrate that Federal requirements in these areas can be met easily, and, if complied with to the fullest, can actually be of benefit to the company. Problem areas encountered by manufacturers are investigated.

The Laser Product Performance Standard reouires interlocks on the protective housing. The standard leaf spring electrical switch commonly used as an interlock is not acceptable. under all conditions imposed in the standard. This paper describes three types of interlocks which meet the requirements of the standard and are commercially available and can be adapted to most products.

Classification of laser products according to the Federal Laser Product Performance Standard depends, in part, on the measurement of laser radiation. The parameters of interest, namely power, energy, irradiance, radiant exposure, and radiance, are discussed. The accessible emission limits for each class of laser product are presented for selected products The measurement requirements of the Laser Product Performance Standard are discussed, namely, power and energy measured in an 80 mm aperture, irradiance and radiant exposure within a 7 mm aperture, and radiance and integrated radiance within a 7 mm aperture and 10-5 steradians. The Bureau of Radiological Health's instrumentation kit is discussed along with a brief description of some of the instruments and their use. Finally, a discussion of instrument calibration procedures and recordkeeping is presented.

Many commercial laser products emit accessible laser radiation that forms spatial patterns. Making measurements of these radiation patterns for Federal laser product classification purposes requires a knowledge of how the patterns are produced, how the Federal laser product standard is interpreted for measurement purposes, and how the limitations of the measurement instrumentation may affect the results. This paper discusses radiation classification measurements for laser radiation in patterns produced by static fan beams as well as dynamic scanning beams.

Exemptions from Federal performance standards for certain laser products for the U.S. Department of Defense and the U.S. Department of Energy have been granted by the Bureau of Radiological Health. A summary of the criteria and requirements for use of these exemptions is presented. A summary is also presented of the criteria and procedures for obtaining an exemption for electronic products intended for U.S. government use that are subject to Public Law 90-602, the Radiation Control for Health and Safety Act of 1968 (42 U.S.C. 263 d-n).

In July 1976 an exemption from the Federal laser performance standards on tactical military laser systems was issued by the Bureau of Radiological Health (BRH). The exemption had an immediate impact upon tactical lasers then in production. The intent of the exemption was to assure some system safety features in tactical lasers while recognizing the military requirements which necessitated a stronger reliance on operational safety measures.

Many questions have arisen prior to and since the effective date of the Federal Performance Standards for Laser Products. The Bureau of Radiological Health has responded with written statements of interpretation or policy that have been distributed to the entire industry. This presentation gives a synopsis of the statements issued to date and covers a variety of subjects ranging from the enforcement policy for laser light shows to the intensity requirements for visibility of emission indicators.

Compliance with the Bureau of Radiological Health's Laser Performance Standard requires that a manufacturer have a thorough knowledge of the standard, that the knowledge be communicated to those parts of the organization that are affected by the standard, and that the compliance efforts of the involved functions be integrated into a well-coordinated and tightly scheduled program. Consideration should be given to delegating responsibility to one individual for acquiring a comprehensive understanding of the standard and for maintaining a current awareness in laser regulatory matters. This individual also would be responsible for defining required tasks for each department and integrating completion dates into a program schedule to meet product delivery commitments. Compliance of both hardware and software should be evaluated at a design review meeting. Preparation of the certification report is a time-consuming task and requires close coordination of effort. The report coordinator should assign tasks, collect information and data and assure that the finished report meets BRH guidance specifications. The manufacturer should anticipate an inspection visit to his plant by a team from the BRH Compliance Division some time after the certification report has been filed. The inspectors will make measurements to verify proper classification of the product, and compliance with performance and labeling requirements will be checked. Quality control and production measurement programs will be reviewed and instrument calibration records examined. Product distribution records will be scrutinized. Compliance with the laser standard involves the manufacturer in a considerable expenditure of time and funds for tasks that would otherwise not be necessary. As an aid to budgeting, a check list of cost elements involved in the compliance program is provided. Important factors involved in exemptions for certain DOD laser products are considered.

The costs of compliance to the BRH Regulations can be minimized by carefully choosing the approach. The paper discusses specific examples used to cut costs. It also outlines the steps for compliance to assist in budgeting for the effort. Companies building lasers into products can take advantage of the safety features built into the purchased laser to satisfy many of the performance features required. Reference can be made to the tests conducted and the reports filed by the laser manufacturer which minimizes the reporting effort. Safety interlocks may be avoided through the use of simple internal shields or by careful definition of the maintenance and service functions. Tests may be eliminated through analysis and the use of vendor data.

The regulations implemented by the Bureau of Radiological Health concerning laser safety have been in force for about a year and a half now. They have had a substantial impact on manufacturer and user alike. Various companies have had various experiences under the regulations, and this paper discusses one company's motivations and experience in marketing the standard and improved safety to the users.

The Federal Performance Standards for Laser Products pose a challenge for the smaller manufacturing companies producing laser products. However, the effects of the Standards can be greatly minimized by thorough interpretation of the Standards, communication with the Bureau of Radiological Health personnel in areas of question, careful product design, and organized implementation of systems. This paper will describe the economic effects of the Standards on a smaller company. I will go into detail of how we at LEXEL Corporation approached the problems of interpretation of the Standards, design of safety labels and features into the product, report writing, and the systems we adopted to assure continued compliance.

The impact of the BRH requirements on a large company are rather significant. As one of our major objectives is the production of a product which is both safe and reliable we have much in common with the BRH Compliance Regulations. The specific manner and the very. detailed procedures impose some problems. To meet the present regulations a very substantial amount of information must be developed. This information requires a set of well organized factual data. In a large company no one person has direct control of or ready access to the amount of information required. This paper will present one company's approach to complying with the requirements, briefly discuss some of the more important problems; and make some recommendations for simplifying and improving the method of reporting. It is our belief that both BRH and all manufacturers will benefit from these proposals without impacting the overall safety of our products.

Laser Images Inc. has been in the planetarium laser light show business for over four years and in that time has had over 5 million patrons experience our show LASERIUM without one laser safety incident. In this paper I will describe the safety measures Laser Images Inc. used to set this record and the impact the recent BRH rulings have had upon Laser Images Inc. operation.

Recent policies of the Bureau of Radiological Health of the Food and Drug Administration on the manufacture and use of laser equipment for light shows are summarized. Specific points covered include determination that laser light shows are products subject to the Radiation Control for Health and Safety Act of 1968, reporting and variance requirements, and criteria for safe design and operation of a laser light show.

There are no binding requirements for manufacturers found in the ANSI Z136.1. The Bureau of Radiological Health (BRH) laser performance standard was patterned after the ANSI Z136 standard and the two standards are reasonably compatible. On the international scene both the World Health Organization (WHO) manual and the International Electrotechnical Commission (IEC) draft standard follow present US standards.

OSHA has been working on the development of an occupational laser radiation exposure standard. Difficulties were encountered in this development process. These included the evaluation of the basic approach used in the laser standard to the anticipated compliance procedures.

Of increasing interest to manufacturers and users of lasers are the laser safety regulations set forth by the various states. These are of particular import since they impact users of laser equipment, in contrast to the Federal BRH Regulations which primarily affect manufacturers. This paper briefly summarizes the state regulations currently in effect, discusses same proposed state regulations, and describes the comprehensive regulations from two states. The Appendix presents a listing of references for gaining detailed requirements from the various states.

Late in 1971, the Conference of Radiation Control Program Directors foresaw the need to consider recommend-ing Suggested State Regulations for Lasers (SSRL) for uniform adoption by all states. This was occasioned by requests from many states who were finding an increased usage of lasers without commensurate effective controls. The committee orignally consisted of F. J. Bradley, New York; William Bryan, Colorado; Joseph F. Thiel, Texas; and Jack C. Rogers, California. Following Wm. Bryan's retirement he asked to be dropped from the committee. The committee's task was to develop a conceptual draft for the Conference to accept and submit to the states for consideration as their regulatory requirements on laser usage. Because of the interest of other agencies in this issue (Federal and other) contact was maintained with such agencies as OSHA, NIOSH, FDA-Bureau of Radiological Health, ANSI Committee Z136.1, as well as with individuals and interested organizations.

I'd like to keep this discussion as informal as possible, but, also orderly and relaxed. First, I'm going to ask members of the panel if they have any comments on what has transpired in the past few days; they might want to make a few preliminary remarks. Then we are going to answer the submitted written questions. Finally, I'll open the questions to the floor.