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FDA recognition of Edition 2:1988 (A1:1991+A2:1995) of IEC 60601-1 is hereby superseded by recognition of ANSI/AAMI ES60601-1:2005, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance. FDA will accept declarations of conformity, in support of premarket submissions, to Edition 2:1988 (A1:1991+A2:1995) of IEC 60601-1 until June 30, 2013. After this transitional period, declarations of conformity to Edition 2:1988(A1:1991+A2:1995) of the standard will not be accepted.+ d. G$ S- c! }( ^3 _
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: _2 s$ h; \4 v# aFDA明年要强制ANSI/AAMI ES60601-1:2005了，谁有相关的标准或资料啊，能分享着一下吗？ |
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发表于 2012-11-14 11:09
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发表于 2012-11-14 13:52
