Z386-08 (R2013)

This CSA Standard is based on ANSI Z136.3-2005. 1.1 Scope This standard provides guidance for the safe use of lasers for diagnostic, cosmetic, preventive, and therapeutic applications in health care facilities (HCF) (see definition, page 5). Lasers used in these applications are incorporated into an apparatus, which includes: (1) a delivery system to direct the output of the laser, (2) a power supply with laser control and calibration functions, (3) mechanical housing with interlocks, and (4) associated liquids and gases if required for the operation of the laser. This document pertains to the safe use of the entire apparatus, which is referred to as a health care laser system (HCLS). This standard is intended for use by all personnel associated with the installation, operation, calibration, and maintenance and service of HCLS. This standard includes engineering, procedural and administrative controls, and laser safety training 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, or any HCF where the laser is being used to treat people. The control measures of this standard apply to all facilities where laser radiation is applied to individuals for recognized health care procedures or for claimed salutary or aesthetic beneficial effect. Suggestions for safe use of specific types of HCLSs, as well as their use in various subspecialties are included in the Appendixes. The Federal Laser Product Performance Standard (FLPPS) for laser products (21 CFR 1040.10 and 1040.11) requires that the operating manuals for HCLSs contain adequate instructions for assembly, calibration (Class 3 and Class 4 laser products), operation and maintenance, including clear warnings concerning precautions to avoid possible exposure to hazardous levels of laser and/or collateral radiation (see Appendix G). Users of HCLSs should obtain information from the operator's manual or direct questions to the manufacturer on suitable eyewear, the nominal hazard zone (NHZ), calibration procedures, or adequate instructions for safe use. If manufacturer's labeling safety information does not exist and cannot be obtained from the manufacturer or the distributor of the laser system, the laser safety officer (LSO) shall provide safety instructions, which shall be incorporated into the standard operating procedure (SOP) for the HCLS, and the LSO shall maintain a copy on file. See Section 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, cosmetic, preventative, therapeutic, or medical/dental research purposes, by or under the direction of qualified professionals engaged in health care.