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最近开始看IEC60601-1第三版的标准,看到一个概念理解的比较模糊,希望大侠们给予指点。
$ M* w# z- C. t4 J# ^, N3.101 RESPONSIBLE ORGANIZATION
" T: ~" [1 S1 q+ K# Xentity accountable for the use and maintenance of an ME EQUIPMENT or an ME SYSTEM+ B) U8 S. Z1 l6 l8 F/ g. E
NOTE 1 The accountable entity can be, for example, a hospital, an individual clinician or a layperson. In home use applications, the PATIENT, OPERATOR and RESPONSIBLE ORGANIZATION can be one and the same person.
4 y3 i) L N2 jNOTE 2 Education and training is included in “use.”
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% C* I/ f i q- P" ]% c我想知道RESPONSIBLE ORGANIZATION是需要制造商定义的么?怎么确定具体产品对应的RESPONSIBLE ORGANIZATION。定义这个RESPONSIBLE ORGANIZATION的目的是什么?会在什么地方用到的比较多?谢谢。 |
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