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8.4 Limitation of voltage, current or energy* j |: |4 I! Z$ u6 m: x
8.4.2 ACCESSIBLE PARTS including APPLIED PARTS/ l- @% y3 w$ ]2 ~
..........................
& Y. R* _& R/ k+ s- D! m( @b) * The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT4 ^8 q: l% v1 ]0 W. I
CONNECTIONS shall not exceed the limits for TOUCH CURRENT specified in 8.7.3 c) when
5 ~: w2 a1 u) o" pmeasured as specified in 8.7.4.5 B$ m1 w* p Z) g) H
c) * The limits specified in b) above do not apply to the following parts if the probability of a# H5 v" Y& N v4 d6 }. }# X
connection to a PATIENT, either directly or through the body of the OPERATOR, through which
) R- [- V' f* G* L8 }+ }9 Z5 D% A0 va current exceeding the allowable TOUCH CURRENT could flow, is negligible in NORMAL USE,
! B3 T( I8 w# band the instructions for use instruct the OPERATOR not to touch the relevant part and the, C1 ^1 [2 G) m/ X" \5 V# R( L
PATIENT simultaneously:
" P4 S4 u' z" g7 L! r8 N% ^* A6 |
– accessible contacts of connectors;6 l4 h# p* W1 ^
– contacts of fuseholders that are accessible during replacement of the fuse;: E. _2 l0 C! D! U" h9 r
– contacts of lampholders that are accessible after removal of the lamp;
3 h% i( { J7 \6 v; q– parts inside an ACCESS COVER that can be opened without the use of a TOOL, or where! F/ p. i* f$ ?/ E
a TOOL is needed but the instructions for use instruct any OPERATOR other than SERVICE
, h( G; p s( j8 C/ o; \: APERSONNEL to open the relevant ACCESS COVER.& K4 p \# \* F1 k' D# I
/ N% r1 H' A8 G1 L! t
EXAMPLE 1 Illuminated push-buttons
$ k( O( r0 L& f6 h2 i$ REXAMPLE 2 Indicator lamps
8 y% J* U" e' j$ P: q0 A/ yEXAMPLE 3 Recorder pens9 l4 { K* c; x
EXAMPLE 4 Parts of plug-in modules& b7 X- ^1 s/ g$ Z& R$ E
EXAMPLE 5 Batteries; \( Q8 I( ~4 L8 Q W
" |6 G2 {% A+ @# J' n& b( z! jFor such parts, the voltage to earth or to other ACCESSIBLE PARTS shall not exceed5 X: {7 P! S6 u2 z' G/ B1 r
42,4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. The d.c.' f" G* L7 i8 w5 I% E/ m
limit of 60 V applies to d.c. with not more than 10 % peak-to-peak ripple. If the ripple% ~3 G, d5 M; H/ ]
exceeds that amount, the 42,4 V peak limit applies. The energy shall not exceed 240 VA7 u2 Q- s9 G( K
for longer than 60 s or the stored energy available shall not exceed 20 J at a potential up, W/ }/ X" c7 w3 R( N9 R* @
to 2 V.5 D0 N5 w3 X5 s. ?. o
NOTE If voltages higher than the limits specified in 8.4.2 c) are present, the LEAKAGE CURRENT limits referred0 t, p4 C+ Z/ H s+ }! I
to in 8.4.2 b) apply.
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) X1 `! W9 E c, j& v2 @) {Compliance is checked by inspection of the RISK MANAGEMENT FILE, by reference to the$ t ?" Z( |: v5 a& D2 i
instructions for use and by measurement.
H0 _8 l& |+ |4 g' A8 P0 M4 ?1 i% J3 z4 Y* q
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。 |
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发表于 2008-10-30 17:35
