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" L+ C& D3 L6 Z$ b8 i* ~, h | Accompanying documents
4 J- @0 J9 R$ H1 B3 F2 u | 6.8.1
! z! M O i% x+ _$ Q4 u2 ? | 60601-1(ed.2);am1;am24 Q! S# u" K( l( ? u, \3 p& F2 E
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Standard(s)- (year and edition):
1 c+ F6 @8 |% i' A/ P, QIEC 60601-1:1988 Ed.2
# C6 |0 J; L D% c; L# _Am1+Am27 t" c" y6 T8 a' R; N
Sub clause(s):: J$ Y' y# L# C3 \, a' j
6.8.1
$ _3 x6 l9 \: ]7 O8 u2 [Sheet n°: 532
2 T5 F3 L: I$ _# D k3 nSubject:# N, p* C: l. t+ o3 }
Accompanying documents8 c5 V! I* k2 R) B
Key words:
+ J/ X, ]* R( C8 zManuals, CD-ROM, Accompanying& e$ \+ K% U- p1 S# H
documents
" p4 G8 x- n. t2 |, V( FDecision taken at the 40th
. f( n4 c* c, n& S4 ~meeting 2003
8 J/ B' G4 s! N) o# t3 g7 NQuestion:; U* _* F' x8 c: p1 [
1) Is it required that accompanying documents shall be provided as hard copy?. v, e( c- F! P0 c4 e: m
2) What if accompanying documents are provided either on CD-ROM or Electronic File Format ?4 o2 M! o2 i# f! r0 U: ]! k& e
Decision:
z+ U* W% V: q' m" |! r% T j, {, G1) Accompanying documents may be in electronic format if acceptable to the USER..* N- \4 K0 d) E, V3 f4 A
2) Please note that at least that part of documentation concerned with safety precautions shall be
, @2 t4 Q3 w8 i# }$ l3 N; J& w. Ereadable with the equipment in normal use and without interrupting a clinical procedure. A risk analysis
: k& K+ B" U, }1 W* O3 jwill indicate whether hard copy is necessary to cover emergency procedures e.g. resulting from power
8 y: G* n- [: G1 ]4 ?8 Q+ s3 Hfailures.+ v6 |3 N0 L! d5 N- {* S1 b1 m
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发表于 2012-9-19 15:52
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