|
|
8.4 Limitation of voltage, current or energy4 A" H8 m- i+ p/ h
8.4.2 ACCESSIBLE PARTS including APPLIED PARTS
- z$ x c$ ?- t( z9 ]# U..........................
# P& D4 T U% D: y! @b) * The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT4 H8 L: l6 A$ ^7 F5 C' X2 L2 D
CONNECTIONS shall not exceed the limits for TOUCH CURRENT specified in 8.7.3 c) when
9 i* Z5 X& W$ y; c( ]3 ~. m6 Lmeasured as specified in 8.7.4." n, g0 {5 {1 }1 K6 n
c) * The limits specified in b) above do not apply to the following parts if the probability of a
/ {' w8 m* L# i6 I" q/ Uconnection to a PATIENT, either directly or through the body of the OPERATOR, through which6 A) `, \+ o8 z7 a( o
a current exceeding the allowable TOUCH CURRENT could flow, is negligible in NORMAL USE,
$ t* Q- z9 {4 E& _6 }and the instructions for use instruct the OPERATOR not to touch the relevant part and the5 r" A# n: \$ i! b0 l
PATIENT simultaneously:
& f0 s" s# G$ V* q& I) W+ I: d; \! t, c/ p! e
– accessible contacts of connectors;
( H% |+ {- m1 V' C9 f0 M– contacts of fuseholders that are accessible during replacement of the fuse;. E5 S- I% ]9 M4 i
– contacts of lampholders that are accessible after removal of the lamp;
0 x8 Y" q& p$ @ a4 O: K– parts inside an ACCESS COVER that can be opened without the use of a TOOL, or where
* C, S2 M# ^) ]# Oa TOOL is needed but the instructions for use instruct any OPERATOR other than SERVICE
! g8 X1 `! o8 \+ p6 D8 fPERSONNEL to open the relevant ACCESS COVER.9 ?7 _) W3 e) a0 t O
6 m$ M/ n+ m. ?- F+ C5 q: @
EXAMPLE 1 Illuminated push-buttons
- U1 z# f7 o, m/ r% _EXAMPLE 2 Indicator lamps; j# E& b2 b1 J* E }4 O, `3 v
EXAMPLE 3 Recorder pens, T9 {# u- q. y5 t' j2 ^
EXAMPLE 4 Parts of plug-in modules* h1 h5 b( R9 j4 o) T
EXAMPLE 5 Batteries
4 F! \1 J# t; u) t1 M% H% S. H* }+ @9 @2 ?+ p+ u: g
For such parts, the voltage to earth or to other ACCESSIBLE PARTS shall not exceed0 Y( q# D% U/ E$ C* t& m+ \! e
42,4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. The d.c.5 }3 H' ^9 i- S" o5 P0 `7 W
limit of 60 V applies to d.c. with not more than 10 % peak-to-peak ripple. If the ripple# Y: X- g8 r) g( d8 ~
exceeds that amount, the 42,4 V peak limit applies. The energy shall not exceed 240 VA2 t. ` M! l; Q: E2 }+ v, y
for longer than 60 s or the stored energy available shall not exceed 20 J at a potential up
. G: t& x" m, r4 N8 Bto 2 V.! H; \1 N- E) R
NOTE If voltages higher than the limits specified in 8.4.2 c) are present, the LEAKAGE CURRENT limits referred& z/ ^+ ^, n$ x
to in 8.4.2 b) apply.
- t0 a6 l: s7 c0 {. G: y& O3 O: x, N! I7 W2 a2 N
Compliance is checked by inspection of the RISK MANAGEMENT FILE, by reference to the, m0 X0 {) W! f; C
instructions for use and by measurement.
3 L# ~% Q c& d
' j; S! ?" L& P1 Y2 R) U我觉得新版本的IEC 60601-1:2006写的最明白了，只要在说明书中说明操作者在接触电池的时候不同时接触患者，电池部位的接触电流的限制是可以豁免的。当然风险分析还是要做一下的。 |
|
/1 
|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
楼主
显身卡
发表于 2008-10-30 17:35
