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8.4 Limitation of voltage, current or energy/ q9 [/ w6 W- n. G& H' t0 ^0 t
8.4.2 ACCESSIBLE PARTS including APPLIED PARTS
7 R2 s1 y6 w" q# a..........................
. r# u5 \* W t- `# \# Ib) * The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT
7 {: u; C6 ^' w2 T* c+ sCONNECTIONS shall not exceed the limits for TOUCH CURRENT specified in 8.7.3 c) when
, S/ ?8 N2 k4 } f" Fmeasured as specified in 8.7.4., w: _; L: V* D% F, w# K4 J
c) * The limits specified in b) above do not apply to the following parts if the probability of a4 y( t e" O& B% _- _; k
connection to a PATIENT, either directly or through the body of the OPERATOR, through which
3 A% T0 o( O% Z) y7 I5 Ra current exceeding the allowable TOUCH CURRENT could flow, is negligible in NORMAL USE,' U8 g' u4 C B5 W' s+ V% _
and the instructions for use instruct the OPERATOR not to touch the relevant part and the' n2 Y" w* f$ @6 v% Y. X; R7 ?
PATIENT simultaneously:6 W4 H5 }, @; N% I
$ p; U# r Y9 l
– accessible contacts of connectors;8 }. y9 A# W1 c7 E' `$ X
– contacts of fuseholders that are accessible during replacement of the fuse;- ]; A) z! T8 X$ U& v2 ?3 v
– contacts of lampholders that are accessible after removal of the lamp;+ e. D1 _: W# B: D* B3 z+ N
– parts inside an ACCESS COVER that can be opened without the use of a TOOL, or where
- w0 b. M& A( S1 T8 P$ T5 e1 Ka TOOL is needed but the instructions for use instruct any OPERATOR other than SERVICE1 A0 O8 w: [2 K/ j% @8 N
PERSONNEL to open the relevant ACCESS COVER.
% [0 \$ G: ]" o
\; g2 i: U. | YEXAMPLE 1 Illuminated push-buttons
6 d+ k% ^: @( [ s: nEXAMPLE 2 Indicator lamps
% M/ ]) B# d* {2 W& x7 CEXAMPLE 3 Recorder pens$ `' A: j. @" J9 h5 d
EXAMPLE 4 Parts of plug-in modules
! l# V9 I2 C4 _4 S7 z8 PEXAMPLE 5 Batteries
6 U* M4 n, {' N" h1 J: o0 L' w0 n- X# j" z* f& Z
For such parts, the voltage to earth or to other ACCESSIBLE PARTS shall not exceed6 I5 B% t0 O8 a2 L* g2 Q6 n9 A
42,4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. The d.c. }" z% r$ v- @! b' ?3 W
limit of 60 V applies to d.c. with not more than 10 % peak-to-peak ripple. If the ripple
$ W# b$ M+ O: dexceeds that amount, the 42,4 V peak limit applies. The energy shall not exceed 240 VA
. y+ b$ K5 K* m+ X2 t( efor longer than 60 s or the stored energy available shall not exceed 20 J at a potential up. d8 z# \7 O) k4 [* \2 o
to 2 V.
; A7 u5 k7 V) E9 ONOTE If voltages higher than the limits specified in 8.4.2 c) are present, the LEAKAGE CURRENT limits referred& A p( t9 ` {
to in 8.4.2 b) apply.
8 k5 m0 b* ?# N V, i& A. F+ ~( Y, q* q \, n- p* _
Compliance is checked by inspection of the RISK MANAGEMENT FILE, by reference to the
% K h" l* y6 D' x1 cinstructions for use and by measurement.
( i% ?+ N4 E" a
7 c$ {5 X1 F& P& |1 R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
