|
|
( {! H! h+ ^7 Z7 B* r* r
0 G A- Z4 s: L5 B | Accompanying documents
0 S3 p5 ~8 M/ v5 Q" X | 6.8.1% @0 u8 v* s+ x; W
| 60601-1(ed.2);am1;am2- P! S$ E2 @9 X2 b; j8 t
|
f3 S' ?1 ?! J' S& N: T# {2 C# l: V( j* r, @
Standard(s)- (year and edition):
" J- T# F) J U( ^+ v9 ]; |IEC 60601-1:1988 Ed.2$ m" u" Y0 P+ C3 Z; A5 R) h
Am1+Am2
9 P2 k6 P& v! R5 k8 a( C- USub clause(s):/ }0 A5 D: I' t& P$ k
6.8.15 \# a( U# F D V
Sheet n°: 532% W, ?$ b+ a8 h; R0 y( u
Subject:1 ]8 W$ m* ^. b1 q0 k4 L: R
Accompanying documents- N, g! ~# v8 k5 J2 |
Key words:, H8 L7 W2 U5 ]( W# q' b
Manuals, CD-ROM, Accompanying v5 W I" _; i# ~
documents6 _& O" }; F4 G& H' u4 z( e
Decision taken at the 40th. [' }' G m6 N8 i/ q
meeting 20036 B1 w- i7 L. z1 d- r
Question:/ W; W6 e9 w& s
1) Is it required that accompanying documents shall be provided as hard copy?( v/ J' c0 g* R# m6 G
2) What if accompanying documents are provided either on CD-ROM or Electronic File Format ?' J2 o5 u6 D* J, s
Decision:
, u, P8 e7 _0 _: ]' \' P1) Accompanying documents may be in electronic format if acceptable to the USER..7 s3 ^" }. T. V
2) Please note that at least that part of documentation concerned with safety precautions shall be4 K+ c8 L9 H& n# x
readable with the equipment in normal use and without interrupting a clinical procedure. A risk analysis
! ~; [" W2 k1 Pwill indicate whether hard copy is necessary to cover emergency procedures e.g. resulting from power
2 C9 j) L9 Y: Q1 F9 ?failures.' M6 o {6 e; W+ P% H& K
, |/ z1 T/ x" ?8 | _0 m. L; T: X, a6 Q/ G
0 V, K! w) H" I4 B0 E. d" p
|
本帖子中包含更多资源
您需要 登录 才可以下载或查看，没有帐号？注册安规
x
|
/2 
|关于安规|小黑屋|安规QQ群|Archiver|手机版|安规网
( 粤ICP13023453-10 ) 
窥视卡
雷达卡
发表于 2012-9-19 15:52
收藏
分享
好帖
鸡蛋
提升卡
置顶卡
沉默卡
喧嚣卡
变色卡
抢沙发
千斤顶
显身卡