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$ `, Q5 s3 v8 s9 ?
0 c4 V) n% _& o+ T" @) H$ B | Accompanying documents# [6 }3 O8 I2 E7 X2 J; H
| 6.8.1$ Y8 Q6 b3 _& F8 M7 {0 W( a: p1 u. v
| 60601-1(ed.2);am1;am2
% ]& L& b6 \- [ |
0 B3 N/ u( ~- _5 P- ^) D' F( ~8 S' `
Standard(s)- (year and edition):
6 c- v. _; Y$ f' C( _. F; GIEC 60601-1:1988 Ed.2; A& b" o2 `! i* A. H8 v( @1 w
Am1+Am2+ z* `$ m! Z8 t# d- [
Sub clause(s):6 R2 O+ Z/ a6 U, T) y, V, _
6.8.1$ o# ]3 X. v: y, v J
Sheet n°: 532
+ t: K- n5 O- n: J/ QSubject:
1 Z0 ], Y( W$ R `, Y4 t3 ~" `Accompanying documents1 c2 j2 }9 {* }9 L/ p( h, r- P+ h
Key words:8 J- ^, r' X( c' G0 f/ v
Manuals, CD-ROM, Accompanying! i$ [9 S4 x2 ?& s' q! j. a
documents# C7 S% D8 [' Y4 p9 R& f5 d
Decision taken at the 40th$ {0 `* ?! V' i$ h+ f/ N
meeting 2003
% v+ O/ E2 q/ P" ~% Q* O2 bQuestion:
3 O4 E( X& ]" |/ l# v( b1) Is it required that accompanying documents shall be provided as hard copy?: [4 J! n8 j; \1 i. g' b
2) What if accompanying documents are provided either on CD-ROM or Electronic File Format ?
; w t0 `$ _( X1 u5 {# G6 V/ ]Decision:8 l: H) C: b/ b5 A$ }/ ?" Y. q
1) Accompanying documents may be in electronic format if acceptable to the USER..
: F/ ]0 y+ @. j2) Please note that at least that part of documentation concerned with safety precautions shall be$ _( `5 s# z+ M, r
readable with the equipment in normal use and without interrupting a clinical procedure. A risk analysis
' @+ S$ Z2 X8 `" H3 Ywill indicate whether hard copy is necessary to cover emergency procedures e.g. resulting from power
! b7 z0 R+ a3 D: O* tfailures.
, P% y \% b' q R# j
3 o, O- b( I/ a( V
: M' l; s& a: g9 F g( I* D6 Y* Q$ ^; r- k6 T2 ~/ s; j+ `
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发表于 2012-9-19 15:52
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