DSH 532 Accompanying documents

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广东安规检测
有限公司提供：

小型摆管淋雨试验机

IPX5X6X7喷水试验机

1000L恒温恒湿箱

各种试验指现货

可程式恒温恒湿试验箱

水平垂直燃烧机

自动卷线器试验机

耐划痕试验机

各种灯头量规现货

灼热丝试验机现货

GB1002插头量规

IPX1-X7淋雨现货

IEC61347/UL935镇流器热试验箱

灯具防风罩

IK冲击试验机

UL498插头插座量规

VDE0620插头插座量规

稳定性试验台

家电温升测试角

针焰试验机现货

热电偶焊机现货

家电125mm试验指

E12灯头量规

无绳壶无绳电熨斗插拔寿命试验机

IEC60335试验指甲

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DSH 532

Accompanying documents * x3 X9 V, a+ n; R

6.8.1 6 x$ `+ N& F. Q6 @6 F" i2 l

60601-1(ed.2);am1;am2 5 A- s; V1 X) w3 {

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Standard(s)- (year and edition):
IEC 60601-1:1988 Ed.2
Am1+Am2
4 @; }7 K3 b& ISub clause(s):
4 G+ D/ `4 i8 \  F* u6.8.1
Sheet n°: 532
Subject:
1 [; Z5 W8 F6 t9 B2 l) p) N% ]Accompanying documents
Key words:
2 D- K. {: f3 i) K/ j, TManuals, CD-ROM, Accompanying
documents
Decision taken at the 40th
meeting 2003
Question:
1) Is it required that accompanying documents shall be provided as hard copy?
2) What if accompanying documents are provided either on CD-ROM or Electronic File Format ?
; x* I3 o8 }. P# x" eDecision:
1) Accompanying documents may be in electronic format if acceptable to the USER..
: I7 a4 [8 c1 |( X1 v) N2 [2) Please note that at least that part of documentation concerned with safety precautions shall be
readable with the equipment in normal use and without interrupting a clinical procedure. A risk analysis
will indicate whether hard copy is necessary to cover emergency procedures e.g. resulting from power
failures.

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