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9 p/ R. `: ~, l5 ~& ^0 S
' o) I# J2 X$ I; x9 l4 f4 R DSH 532
+ j2 s# p% R, P: p& J2 I+ r | Accompanying documents
* h8 V2 t# \ V/ y | 6.8.1
! K: [/ D* K6 G! ~2 F( ?1 U" C | 60601-1(ed.2);am1;am24 q- R1 [; h. l+ ?/ t5 q! x' z
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" m( L% ~8 `# X7 |+ K: J# E. {Standard(s)- (year and edition):
" x7 ]9 g) s- E8 Q4 q. kIEC 60601-1:1988 Ed.2
# P" `! v. \. [0 J! R5 `! u n+ d# IAm1+Am2' Q) X& N+ Q8 d: t0 B) e
Sub clause(s):
' d: S: D" H5 m5 }) a7 x6.8.13 [+ ]* I6 a8 e, F# D
Sheet n°: 5328 g6 L$ ?( U3 I" g8 G; u1 V9 U# W2 B
Subject:8 T3 }0 v" S% e) b2 u/ u4 L$ W
Accompanying documents
: x& f0 \6 t% K) {Key words:
; [; A& c+ v% }: v( UManuals, CD-ROM, Accompanying
9 X- n. N6 S, \& R+ U9 [& Rdocuments* h, }" S' B, t% @3 Z( _
Decision taken at the 40th; s3 h2 ~3 t' {: i3 A
meeting 2003 K F) t- [) h/ W
Question:
5 r8 C2 R- {: b1) Is it required that accompanying documents shall be provided as hard copy?% P B4 b* g5 W
2) What if accompanying documents are provided either on CD-ROM or Electronic File Format ?3 B6 q5 l# o! }5 u% H/ a
Decision:" w6 c" t6 H) Y# k0 k) b
1) Accompanying documents may be in electronic format if acceptable to the USER..
$ k3 b- w! Z9 V/ @3 A2) Please note that at least that part of documentation concerned with safety precautions shall be
; s1 p" G! ^- R0 ureadable with the equipment in normal use and without interrupting a clinical procedure. A risk analysis3 [0 z& \0 L8 C* ? o# A
will indicate whether hard copy is necessary to cover emergency procedures e.g. resulting from power. l6 J# q& E( p1 a$ e
failures.
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" D; W: x3 o1 v" E$ \, b) D
7 ^1 x# ~1 o$ j5 ^+ }) `$ x1 {7 \* G* D* z5 }: _: @* @3 c2 ]
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发表于 2012-9-19 15:52
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