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" _. T3 v$ C9 u# g | Accompanying documents
% |: d; B, J6 ]* i5 X7 Y | 6.8.1
/ ~$ q; I S3 |6 k4 n2 l% e' B | 60601-1(ed.2);am1;am2
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4 E( i7 I0 @, d" bStandard(s)- (year and edition):
" C8 Y8 v/ Z# B; S1 ]- zIEC 60601-1:1988 Ed.2* ?2 {. h! G" T$ m% }) B
Am1+Am2
9 S+ C# f5 k* R* r6 L/ |5 |Sub clause(s):
. ^' k4 t7 V, O1 A6.8.1
# n+ r) U8 t/ N& N5 M' BSheet n°: 532
+ e( |* f# D3 S- |9 `Subject:
2 C$ \ f9 t7 v8 J+ N* A2 tAccompanying documents
) c a# o0 f9 lKey words:- c) ^ n# s; ]$ O; u% c
Manuals, CD-ROM, Accompanying
# s( Q5 J2 i1 o) _$ i6 s: r9 j, Rdocuments
' J, {* Z$ d9 ZDecision taken at the 40th
Q3 e* w' D* w7 X+ Zmeeting 2003
/ M8 h" G0 X# [; M( S1 ?Question:' e- e$ T7 I2 S6 C, J3 }
1) Is it required that accompanying documents shall be provided as hard copy?
( W7 b. a& n# e) f2) What if accompanying documents are provided either on CD-ROM or Electronic File Format ?
8 J' P6 }! ~6 h" C0 tDecision:# ]9 G d" l ]: u8 }9 D6 |
1) Accompanying documents may be in electronic format if acceptable to the USER..+ Z2 |( K! M u* Y# I5 Y
2) Please note that at least that part of documentation concerned with safety precautions shall be, a4 o4 g/ G' K2 I9 y
readable with the equipment in normal use and without interrupting a clinical procedure. A risk analysis( m1 G3 `' z+ h" D* c7 }
will indicate whether hard copy is necessary to cover emergency procedures e.g. resulting from power# T' E, r1 n; k
failures.) m q, L2 e9 z1 R1 r ^
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发表于 2012-9-19 15:52
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