DS/EN 60601-2-39/A11-2011

Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment


 

 

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标准号
DS/EN 60601-2-39/A11-2011
发布日期
2011年12月03日
实施日期
2011年12月03日
废止日期
国际标准分类号
11.040.20
发布单位
DK-DS
代替标准
DIN 52099-2013
适用范围
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PERITONEAL DIALYSIS ME EQUIPMENT as defined in 201.3.208, hereafter referred to as ME EQUIPMENT. It applies to ME EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including ME EQUIPMENT operated by the PATIENT, regardless of whether the ME EQUIPMENT is used in a hospital or domestic environment.If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both




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