Z386-01

This Canadian Standard is based on ANSI Z136.3-1996, Second Edition, 1996-02-07. 1.1 Scope This Standard provides guidance for the safe use of lasers for diagnostic, therapeutic, and medical research applications in health care facilities. Lasers used in health care applications are incorporated into an apparatus which includes a delivery system to direct the output of the laser, a power supply with control and calibration functions, mechanical housing with interlocks, and associated fluids and gases required for the operation of the laser. This document pertains to the safe use of this entire apparatus, which is referred to as a Health Care Laser System (HCLS). This standard is intended for use by all persons associated with the installation, operation, maintenance and service of Health Care Laser Systems. This standard includes engineering, procedural and administrative controls necessary for the safety of patients and health care professionals. These controls are based upon: evaluation of potential hazards from laser radiation: unique problems related to operating rooms, outpatient clinics, mobile laser units, and private medical and dental offices: and exposure risks to patients and professional staff. Included are engineering and administrative controls, personnel protective equipment, and laser safety training. Suggestions for safe use of specific types of HCLS and use of HCLS in various subspecialties are included in the appendixes. The Federal performance standard for laser products (21 CFR 1040.10 and 1040.11) requires that the operating manuals for HCLS contain adequate instructions for assembly, operation and maintenance, including clear warning concerning precautions to avoid possible exposure to hazardous levels of laser and/or collateral radiation. (See Appendix E). Users of HCLS should obtain information or direct questions on suitable eyewear, the Nominal Hazard Zone (NHZ), calibration procedures, as well as adequate instructions for safe use from the manuals or the manufacturers of the HCLS. If manufacturers labeling safety information does not exist and cannot be obtained from the manufacturer of the distributor of the laser system, the Laser Safety Officer (LSO) shall provide alternative safety instructions which shall be kept on file. See 1.3 for LSO definition and responsibilities. The control measures contained herein are not intended to restrict or limit in any way the use of laser radiation, of any type, which may be intentionally administered to an individual for diagnostic, therapeutic, or medical/dental research purposes, by or under the direction of qualified professionals engaged in health care. These qualified professionals retain the ultimate responsibility for the safe use of lasers and laser systems in health care facilities.