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8.4 Limitation of voltage, current or energy( a4 X& @( D, M" f& z
8.4.2 ACCESSIBLE PARTS including APPLIED PARTS9 o5 D9 N# V" ]/ o
..........................
6 ~2 z3 B# ^! k3 R5 Cb) * The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT
2 J/ A% o) c( i* nCONNECTIONS shall not exceed the limits for TOUCH CURRENT specified in 8.7.3 c) when
% v7 V: e7 C6 u5 ?3 O+ N. Rmeasured as specified in 8.7.4.
: n7 r+ w! ]' ~c) * The limits specified in b) above do not apply to the following parts if the probability of a3 {- W# Q7 A0 b7 q3 u
connection to a PATIENT, either directly or through the body of the OPERATOR, through which
/ @6 j3 r1 s4 `3 Ra current exceeding the allowable TOUCH CURRENT could flow, is negligible in NORMAL USE,9 @1 N K7 v3 R' X$ W
and the instructions for use instruct the OPERATOR not to touch the relevant part and the: N! _3 z: X- _$ t0 P# a
PATIENT simultaneously:( r& E" }' C! V2 {
& Q* Y. l u8 A
– accessible contacts of connectors;' N8 W V( j+ H" H! f/ g% F
– contacts of fuseholders that are accessible during replacement of the fuse;
! H8 @4 x, m3 Y( _ P& h– contacts of lampholders that are accessible after removal of the lamp;/ }! U8 u6 \# a0 p
– parts inside an ACCESS COVER that can be opened without the use of a TOOL, or where
# F% W* G: Q% Z9 w# m- B8 P8 _a TOOL is needed but the instructions for use instruct any OPERATOR other than SERVICE6 k$ a. C& u5 B) L: A
PERSONNEL to open the relevant ACCESS COVER.
% O1 S, Z7 Q6 O4 [3 H
) e3 d7 l- l! g( a; l4 iEXAMPLE 1 Illuminated push-buttons
. ?3 t; @8 t- M' o4 K2 u2 xEXAMPLE 2 Indicator lamps; b: i5 c( `& {* T: G, W
EXAMPLE 3 Recorder pens1 R1 H2 _& ^ a; E; k; \4 D
EXAMPLE 4 Parts of plug-in modules
, h0 t, U% q( gEXAMPLE 5 Batteries
# K+ O+ ~1 ^& \# A" \) _
3 [; Y6 [* ?7 t sFor such parts, the voltage to earth or to other ACCESSIBLE PARTS shall not exceed2 _' J* s7 ~) Y# @6 f6 Q& m
42,4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. The d.c.
# j0 a8 Q! n2 T8 i( [6 Y+ c# V/ Blimit of 60 V applies to d.c. with not more than 10 % peak-to-peak ripple. If the ripple
' m2 _! O- {, _exceeds that amount, the 42,4 V peak limit applies. The energy shall not exceed 240 VA0 @+ u# A" }* I5 |: {' l
for longer than 60 s or the stored energy available shall not exceed 20 J at a potential up5 |) Y2 @/ `7 N u: t" g- N4 d+ W% R6 E
to 2 V.
6 H2 k1 O. @& XNOTE If voltages higher than the limits specified in 8.4.2 c) are present, the LEAKAGE CURRENT limits referred# E' J8 a) K$ {- t, `0 U
to in 8.4.2 b) apply.1 N) F: ^8 A$ D( C+ e
, j+ E7 u9 z- `% A# W. i dCompliance is checked by inspection of the RISK MANAGEMENT FILE, by reference to the
' g- |; ]1 A1 S+ C5 m. tinstructions for use and by measurement.
# A1 M8 G! }& n$ c$ g( [! u
: k) y, [6 T" J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
