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# ^! y( z/ \0 _, r: Z1 v) L( B3 o | Accompanying documents
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( m% M8 o& E8 G5 \- A5 Y7 @. a8 D | 60601-1(ed.2);am1;am2
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Standard(s)- (year and edition):
& M0 I" ^1 C- O/ BIEC 60601-1:1988 Ed.2
/ l8 k# J0 }0 S$ LAm1+Am2
$ g( P9 S0 [ O0 v: y2 X( \Sub clause(s):
2 r" g7 x+ I2 {2 J6.8.1
1 u8 ~$ t$ Q6 ISheet n°: 532
% ] h% A8 e; X4 ~( i, F4 g& ^Subject:
7 L, z) f2 {# m8 V0 QAccompanying documents
$ r' d7 S/ i' u5 h3 ^Key words:
. t- i# l3 t' l, `Manuals, CD-ROM, Accompanying
, s( V8 r( K& J1 \# Ydocuments
' ~- Q3 @7 B3 M) k/ UDecision taken at the 40th# q% j! W, b0 `3 ?( s0 F$ o- Z
meeting 2003$ [% j' H0 g/ f; q i
Question:# K# `- S0 Q# K0 n6 C$ W
1) Is it required that accompanying documents shall be provided as hard copy?
/ G7 [+ k3 Z: V8 V2) What if accompanying documents are provided either on CD-ROM or Electronic File Format ?
) y) e& `% k7 {" p( a m: wDecision:
2 c: C& t8 V, ?8 q4 }7 I5 |1) Accompanying documents may be in electronic format if acceptable to the USER..4 V4 s/ V2 t& f; B+ g
2) Please note that at least that part of documentation concerned with safety precautions shall be
0 O; x0 S7 T+ f; Wreadable with the equipment in normal use and without interrupting a clinical procedure. A risk analysis
9 {9 c9 `; P* K5 v$ c+ Q M: Gwill indicate whether hard copy is necessary to cover emergency procedures e.g. resulting from power
! I% F/ b3 k2 k5 _& Ofailures.2 W, x# ^/ K; K* N- n# @) {
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