PubMed · 4077675
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D J McIntyre. 1985. Safe and efficacious?. https://doi.org/10.1016/s0146-2776(85)80141-5
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Lasers are a key component of the vision practitioner's arsenal of care, and provide a wonderful new frontier of diagnostic and therapeutic options. In light of their expanded utilization, it is crucial that eye care practitioners have a thorough understanding of potential laser hazards and the regulations that establish guidelines for their safe application. This review describes the American National Standards Institute (ANSI) standards applicable to the safe use of lasers (Z 136.1) and the safe use of lasers in health care facilities (Z 136.3). Laser hazard classification, the organization of a laser safety program, and administrative and procedural controls are included.
On January 1, 1995 the law concerning medical products (Medizinproduktgesetz-MPG) came into force. It essentially regulates the production, circulation, and the putting into service of medical products as well as equipment. Among other things, the so-called active medical products include medical X-ray equipment whose aspects concerning atomic law remain covered by the radiation protection regulation for X-ray sources (RöV). Parallel to the coming into force of the MPG, the RöV was modified (Section 50, MPG), which in future might result in considerable consequences for the manufacturer, the operator, and the authorities.
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