Safety Standard and Their Trend Relating to Lights and Lasers

Abstract

This report explains the international and Japanese safety standards about the medical laser equipment. Basic standard is “IEC 60825-1 Safety of laser products” , correspond to JIS C6802. The related standard is “IEC 60601-2-22 Medical electrical equipment - Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment”. These standards provide the following clause: terms and definitions, general requirements, label, classified class, MPE “Maximum Permissible Exposure” and user’s guide. Accident and incident reports are important for making standard. The new standard of “IEC 60601-2-57 Medical electrical equipment: Particular requirements for the safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use” is established on Intense Pulsed Light (IPL) soon. Standardization work hit upon regulatory science.