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8.4 Limitation of voltage, current or energy+ @9 A5 S. X& o/ S% A
8.4.2 ACCESSIBLE PARTS including APPLIED PARTS$ W: u* D% `" `* W/ [
..........................
5 w, O' U2 k. p+ |: lb) * The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT) R% x0 `( \/ M& b# c% U
CONNECTIONS shall not exceed the limits for TOUCH CURRENT specified in 8.7.3 c) when6 Y( i, ^, E0 ] j
measured as specified in 8.7.4.
" ]5 t% Q* C4 D3 |- U% }$ O% Rc) * The limits specified in b) above do not apply to the following parts if the probability of a
! B* {6 P# C. A* s. X& u" B5 E+ c# Zconnection to a PATIENT, either directly or through the body of the OPERATOR, through which
5 v2 P1 s+ v- f& v: k R6 ja current exceeding the allowable TOUCH CURRENT could flow, is negligible in NORMAL USE,
& l2 j; x& ?) n8 k/ `" Y' Fand the instructions for use instruct the OPERATOR not to touch the relevant part and the
0 ~7 ^+ ^5 b# x6 Q, GPATIENT simultaneously:% X; z, C+ o( B! ^* @
$ X5 x0 Y& G, q( R8 B. i
– accessible contacts of connectors;
6 D7 \/ o( s5 Q. l# G+ x N/ J– contacts of fuseholders that are accessible during replacement of the fuse;
6 d- K# j" a8 o9 j* z& o– contacts of lampholders that are accessible after removal of the lamp;2 D7 q1 {' B- h* m% t
– parts inside an ACCESS COVER that can be opened without the use of a TOOL, or where$ {8 h w) }1 Y( U0 c- G8 T
a TOOL is needed but the instructions for use instruct any OPERATOR other than SERVICE$ u" x9 H/ d, X7 k5 L' ~8 K: w
PERSONNEL to open the relevant ACCESS COVER.+ S7 h7 L+ m, K# {: o4 a
. l d( s3 D! |( _! W' \
EXAMPLE 1 Illuminated push-buttons
. _* \, R* }: J( fEXAMPLE 2 Indicator lamps4 _$ t- K1 H" [$ {: @# t% Q
EXAMPLE 3 Recorder pens
0 d! T# v- R& ~EXAMPLE 4 Parts of plug-in modules: g* \5 J4 h/ `
EXAMPLE 5 Batteries1 i6 p8 z) N5 D) j# r% Y' p
) O8 K0 q& C6 ~& \- `/ ?; ~
For such parts, the voltage to earth or to other ACCESSIBLE PARTS shall not exceed* ?8 W+ f; H9 t5 l# e7 G% m
42,4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. The d.c.
, Z h5 `% `6 T! Jlimit of 60 V applies to d.c. with not more than 10 % peak-to-peak ripple. If the ripple, z5 T; g8 O$ n2 Q5 x
exceeds that amount, the 42,4 V peak limit applies. The energy shall not exceed 240 VA/ { `8 S+ Q& \( t7 o
for longer than 60 s or the stored energy available shall not exceed 20 J at a potential up* L) m- |/ z- D* J" Y3 E# t x
to 2 V.8 s: R( p# S# ~
NOTE If voltages higher than the limits specified in 8.4.2 c) are present, the LEAKAGE CURRENT limits referred5 @0 A' s+ {, Q0 y8 q; e. l
to in 8.4.2 b) apply.
+ ]1 w8 N- ]! H% z/ @8 x0 }$ a! `+ M" ]$ C0 N1 z
Compliance is checked by inspection of the RISK MANAGEMENT FILE, by reference to the
! h$ o+ u, w/ y4 c5 O# Einstructions for use and by measurement.0 |0 b j) K2 d0 r+ J7 |, o* X
% |1 f+ ?8 u1 E$ K
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
