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9 M$ B2 \% \$ U4 b. o% F
+ q- v" z Z2 @, W# h4 A& F
| Accompanying documents" D4 C& P& [2 t$ X8 h
| 6.8.1) W) I4 a2 M7 f9 ^: t( J' q1 s
| 60601-1(ed.2);am1;am2+ ?, Y! {0 W! U/ }6 R" X$ M
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Standard(s)- (year and edition):
; Y- o! v$ i3 X. d5 D6 H9 q @& AIEC 60601-1:1988 Ed.2' g; O, n, ^: ^8 {: s
Am1+Am2
) ]: B7 }* y0 sSub clause(s):
! N. @) f2 _2 K. p6.8.1
, D" I3 q' l) O& z3 o6 ^! @Sheet n°: 532, u I" ~( O$ z7 u7 n4 k3 I
Subject:2 W: ?. G; Z) R5 n* |; A
Accompanying documents
1 x, \: c. J0 {/ x$ y8 W8 @Key words:
O ^4 y- ]/ I+ v1 V" ?. CManuals, CD-ROM, Accompanying; S, O7 {3 f# Y9 O! ]& j3 C: A: ?; @
documents
8 j' ^# n5 c5 G6 a: h7 ]! }2 P/ r, e" dDecision taken at the 40th
4 b" [9 ?" n9 L2 t, E" Lmeeting 2003& t5 F1 I& h' S4 O
Question:
9 g J; O/ Z5 W) F0 w0 \" C% a1) Is it required that accompanying documents shall be provided as hard copy?
$ S! j2 I9 b' Z$ Y$ v/ ~/ C; g2) What if accompanying documents are provided either on CD-ROM or Electronic File Format ?1 m4 ^. e6 S9 r- v# M
Decision:
. r5 F7 U! C( V, X1) Accompanying documents may be in electronic format if acceptable to the USER..
4 }0 a; g' M! b. O2) Please note that at least that part of documentation concerned with safety precautions shall be
: |% P6 o1 q+ [readable with the equipment in normal use and without interrupting a clinical procedure. A risk analysis
* c7 E3 p# @, lwill indicate whether hard copy is necessary to cover emergency procedures e.g. resulting from power" i" s0 h% d7 ~8 h& N
failures.
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