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本帖最后由 lxxcumt 于 2015-10-22 14:09 编辑
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9 D% N0 j1 q4 b) C属于可拆卸部件。6 K: |; t% {, {( h& p
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instruction for use →使用说明书 → 用户1 Z- _" N, o) B+ j( _: Y: b
说明书中提供了拆卸步骤,说明用户可以自己拆卸和安装。
0 E1 f5 ^- H3 a2 f' e6 B" s从用户安全角度来说可以供用户拆开区域的电气防护应该和器具外部accessible的部分相同。+ j. b3 P5 Z) n
既然你允许我拆,还教我如何拆,你就得对我负责到底!
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1 b# V- N# j3 L: @0 P" R4 X4 nIEC 60335-1中好像更喜欢用operation
, n% Z, a6 R5 A0 P, `0 M. O4 Rintended use (operation)! z& [: E7 |2 T j3 f- @+ G
normal use (operation)
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Instructions for use 显然包含intended use and normal use,暂时这样理解% r# j# J% R3 H! k
' Q" b* m2 k: ^/ m! y他山之石可以攻玉/ }2 ?& s# j0 m4 c& A
从IEC 60601-1:2012中可以看出:' C, I9 z; K9 Y$ b0 K
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* INTENDED USE
9 R8 h" ? x' @# ~3 W' fINTENDED PURPOSE
8 ^8 P a d+ k- ~4 _$ ]. W6 ruse of for which a product, PROCESS or service in accordance with is intended according to the
2 i/ h( Q8 n" `& x( [: cspecifications, instructions and information provided by the MANUFACTURER [ISO 14971:20002007, definition 2.5] ( v$ M9 b$ m! e" @! g
NOTE INTENDED USE should not be confused with NORMAL USE. While both include the concept of use as intended by the MANUFACTURER, INTENDED USE focuses on the medical purpose while NORMAL USE incorporates not only the medical purpose, but maintenance, service, transport, etc. as well., x3 B n d. l o G! W0 V$ }
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NORMAL USE
( |3 X( s( u1 i& {2 Zoperation, including routine inspection and adjustments by any OPERATOR, and stand-by,
$ @' U* V, J! m# \4 X( x' X1 haccording to the instructions for use \' V1 {5 h* g0 g6 e1 {
NOTE NORMAL USE should not be confused with INTENDED USE. While both include the concept of use as$ ? `3 M; q6 X% G4 t0 t7 m
intended by the MANUFACTURER, INTENDED USE focuses on the medical purpose while NORMAL USE incorporates not
+ h8 A% w3 N. h6 _: `only the medical purpose, but maintenance, service, transport, etc. as well.1 i6 x' p( U' g: e6 x4 a
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