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标题: DSH 532 Accompanying documents [打印本页]
作者: 小米    时间: 2012-9-19 15:52
标题: DSH 532 Accompanying documents
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DSH 532; i0 A" G1 B# r, l- T' C* P; e2 h
Accompanying documents8 V1 O  f( Y4 `7 G$ Q5 @% B& ~
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60601-1(ed.2);am1;am2+ P( M3 A8 ?- \4 b
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Standard(s)- (year and edition):
" a  \. r8 Q+ r+ t9 r/ ]1 `8 ZIEC 60601-1:1988 Ed.2
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Sub clause(s):+ c. R. B; g* a
6.8.1
9 B3 Y- u/ k4 K) ?" G3 PSheet n°: 532
' l$ D$ H5 l& aSubject:  x* W- C9 z: v9 E5 a. K* X2 i
Accompanying documents
! f/ j3 k. ?- h/ T9 MKey words:
, Y! S: R! M7 O8 ~3 I: rManuals, CD-ROM, Accompanying
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1 t% f3 Y  H$ z# S( K9 ~7 J# q; G& PDecision taken at the 40th! ^- q" g8 R0 U9 G
meeting 2003
8 L8 O1 ]* w+ q& _Question:
+ T+ l3 {3 Q; }# E$ J. G1) Is it required that accompanying documents shall be provided as hard copy?
! G+ {+ j1 y6 {  V2) What if accompanying documents are provided either on CD-ROM or Electronic File Format ?
7 D: N- q  o! gDecision:9 O/ {( \) @, P- [! X
1) Accompanying documents may be in electronic format if acceptable to the USER..7 W; ~5 P8 l9 x+ }) N& x& z
2) Please note that at least that part of documentation concerned with safety precautions shall be
1 w4 j7 O" ?4 _5 X  Hreadable with the equipment in normal use and without interrupting a clinical procedure. A risk analysis+ l5 ?1 R- S! v8 v" X9 l! [
will indicate whether hard copy is necessary to cover emergency procedures e.g. resulting from power6 E" b: j' G/ j  Y# c9 w
failures.
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2 S0 m( s# I" h/ z; L* E[attach]76263[/attach]
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