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* [( x! Q: r" ?$ | | Accompanying documents
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2 \: b$ \; W$ ~6 F8 l | 60601-1(ed.2);am1;am2
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9 E+ ~9 m/ ?- m% e' hStandard(s)- (year and edition):
3 O' b0 t9 J. g0 a5 oIEC 60601-1:1988 Ed.2
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. I8 G; I* |* f! r$ y- d5 F1 cSub clause(s):' ^: d" ?1 K- e. a% N7 g
6.8.1/ v# G5 D% I5 [3 a' n& X4 \
Sheet n°: 532
" u6 W9 C, Q6 G5 e: O% zSubject:1 X; k& ]$ N8 ^' _ O9 _
Accompanying documents" b$ W b6 {! h, E6 ~
Key words:! d6 c2 Y) r3 X$ q
Manuals, CD-ROM, Accompanying
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Decision taken at the 40th
$ Y" n- ]1 X# y7 y( l$ J; ]meeting 2003
( d6 Q+ `( Q* G5 ~Question:
* l% c( d8 L( V ~3 Q: m8 V1) Is it required that accompanying documents shall be provided as hard copy?
9 f8 X$ {, E4 y4 o [2) What if accompanying documents are provided either on CD-ROM or Electronic File Format ?
# ~ F& x Y2 ]- u2 yDecision:6 [2 V) @/ ]% _. @6 W
1) Accompanying documents may be in electronic format if acceptable to the USER..: H2 n4 e1 [! I( u9 Q( ]4 T
2) Please note that at least that part of documentation concerned with safety precautions shall be+ w% @2 v% B" o7 `1 M+ u( O. N
readable with the equipment in normal use and without interrupting a clinical procedure. A risk analysis
3 l2 \& ^ z5 \. O4 x' _. W Z# pwill indicate whether hard copy is necessary to cover emergency procedures e.g. resulting from power
1 w0 h0 t0 [) j. J9 n4 u+ ofailures.
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发表于 2012-9-19 15:52
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