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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。. R+ q+ b2 b4 }0 Z
3.101 RESPONSIBLE ORGANIZATION' |! h) I4 |% m+ Z4 |
entity accountable for the use and maintenance of an ME EQUIPMENT or an ME SYSTEM
/ F0 H9 l, G* `8 A: h* ~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.' @ V" o {( |0 d: l( h
NOTE 2 Education and training is included in “use.”; B1 z, S Q' q4 Q5 H3 Y
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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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