
Medical electrical equipment Part 1: General requirements for safety
出版:Japanese Standards Association

专家解读视频
This Standard applies to the safety of MEDICAL ELECTRICAL EQUIPMENT (as defined in Sub-clause 2.2.15). Although this Standard is primarily concerned with safety, it contains some requirements regarding reliable operation where this is connected with safety. SAFETY HAZARDS resulting from the intended physiological function of EQUIPMENT covered by this Standard are not considered. Appendices in this Standard are not mandatory unless made so by an explicit statement in the main text.
IEC 60601-1 Ed. 3.0 - Equivalent