DSH 532 Accompanying documents

小米

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

6.8.1 9 [$ P+ Y; U. a: g# r

60601-1(ed.2);am1;am2 $ A" H3 n* k1 B; m0 z7 M

Standard(s)- (year and edition):
IEC 60601-1:1988 Ed.2
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Sub clause(s):
6.8.1
Sheet n°: 532
1 U" ]1 m7 Q% L- i$ X7 e6 T9 tSubject:
$ k3 E5 U6 _  p# FAccompanying documents
0 p% u6 \' [& i# V4 }Key words:
Manuals, CD-ROM, Accompanying
( l) M2 C! h3 w- J6 o9 Odocuments
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 ?
! w1 X8 T" |* N5 }Decision:
$ k5 I4 `  C- h/ B2 i8 g0 L1) Accompanying documents may be in electronic format if acceptable to the USER..
/ n0 c8 B  r9 M+ O9 {$ y* X( \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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