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8.4 Limitation of voltage, current or energy
1 e( G- [) L/ g5 e( y( t8.4.2 ACCESSIBLE PARTS including APPLIED PARTS6 b" c Q2 J8 R- W2 u+ q
..........................8 _8 L$ Q o5 I0 F) H3 ]: b0 J/ B) U
b) * The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT. f+ a6 H$ I4 @$ K0 o- \
CONNECTIONS shall not exceed the limits for TOUCH CURRENT specified in 8.7.3 c) when
. S- W+ ^- D; J& xmeasured as specified in 8.7.4.
9 H' `9 X4 z, u' a0 N! ~c) * The limits specified in b) above do not apply to the following parts if the probability of a
% ~( f: H+ n' B [" x2 M7 \0 @connection to a PATIENT, either directly or through the body of the OPERATOR, through which: w2 Y* L% F5 \ `! {% U& i4 @8 `
a current exceeding the allowable TOUCH CURRENT could flow, is negligible in NORMAL USE,* ?# ?. x K" y; @
and the instructions for use instruct the OPERATOR not to touch the relevant part and the
* U5 p+ b! ~2 e$ \ I' k& PPATIENT simultaneously:) j# i6 k* q5 e& j% ] w( F: w+ r
* J6 {+ A" o( ~/ k
– accessible contacts of connectors;. k1 `9 t8 @5 ^
– contacts of fuseholders that are accessible during replacement of the fuse;& ~9 R( S- d7 B% e
– contacts of lampholders that are accessible after removal of the lamp;4 U2 [2 Q4 \) @# p' S
– parts inside an ACCESS COVER that can be opened without the use of a TOOL, or where' Y0 q0 T$ a# `! a9 E2 c
a TOOL is needed but the instructions for use instruct any OPERATOR other than SERVICE* Z7 {3 ` [ z9 M8 J
PERSONNEL to open the relevant ACCESS COVER.
+ I: ?9 w) o7 x+ V/ y8 F5 G3 E, P8 `, K; L0 M. W8 w
EXAMPLE 1 Illuminated push-buttons
! P, T4 s! ^# K$ h5 O4 z/ }EXAMPLE 2 Indicator lamps6 q" N) K0 E9 m2 z& e5 w
EXAMPLE 3 Recorder pens/ a" O+ N7 e* w" X" C
EXAMPLE 4 Parts of plug-in modules
2 |! T4 n4 l7 B) b2 J6 _EXAMPLE 5 Batteries- L# }0 n" @3 @2 j! }+ K W( h
( ^6 S2 F3 Z% T6 ^4 l) i+ M: G% k) k5 \; `
For such parts, the voltage to earth or to other ACCESSIBLE PARTS shall not exceed
( t) \. w$ ]) Y( e4 h0 C( G7 a5 ^ t42,4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. The d.c.
. v+ p( ]& j* e+ P+ Q" L' m+ Klimit of 60 V applies to d.c. with not more than 10 % peak-to-peak ripple. If the ripple
6 e" Z/ R! G# C+ B# Z1 P' Uexceeds that amount, the 42,4 V peak limit applies. The energy shall not exceed 240 VA
; ^( @) _5 y# q1 b+ vfor longer than 60 s or the stored energy available shall not exceed 20 J at a potential up
. w `2 ^3 l. L' A$ u- J9 I0 Hto 2 V.
* `; R. C! s5 |- rNOTE If voltages higher than the limits specified in 8.4.2 c) are present, the LEAKAGE CURRENT limits referred
. Y, ^6 d* ]9 \9 `8 @2 J; lto in 8.4.2 b) apply.
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( ^. F; S' P4 d5 G) o6 K! |Compliance is checked by inspection of the RISK MANAGEMENT FILE, by reference to the9 Z5 |4 g" E$ o) [' \; `* c$ `
instructions for use and by measurement.
4 Z0 a' w7 \6 o% X9 S& N0 p, s
0 N/ y' |9 B& n5 c* C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
