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8.4 Limitation of voltage, current or energy
& }" G, I0 p8 |8 h5 P/ O8 y0 f, O8.4.2 ACCESSIBLE PARTS including APPLIED PARTS- A5 a- p) j5 C) u5 }
..........................5 \4 `* o% N; R1 R. z
b) * The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT
% ]4 S! p! w/ Z g- M' v* m2 FCONNECTIONS shall not exceed the limits for TOUCH CURRENT specified in 8.7.3 c) when$ y& N2 W2 P) b! |. r/ y/ S
measured as specified in 8.7.4.
5 d" J4 ` c6 hc) * The limits specified in b) above do not apply to the following parts if the probability of a
$ L: k: V) W* ? L% u/ d$ \% lconnection to a PATIENT, either directly or through the body of the OPERATOR, through which
' u* m2 k$ e Oa current exceeding the allowable TOUCH CURRENT could flow, is negligible in NORMAL USE,. Y6 Y9 ^0 u. C" V
and the instructions for use instruct the OPERATOR not to touch the relevant part and the
% @2 u/ o" N1 K; M$ `+ Y; k8 }* I$ mPATIENT simultaneously:- I" n) W9 U3 \: _
+ `: I" f( ~8 i+ ^– accessible contacts of connectors;/ i$ ]# d. s; M' f0 U* H2 ]0 V+ b: S
– contacts of fuseholders that are accessible during replacement of the fuse;* g- L) `( `( ~- k- I
– contacts of lampholders that are accessible after removal of the lamp;( z+ u8 V% P. ]8 Z/ E% d" U/ P
– parts inside an ACCESS COVER that can be opened without the use of a TOOL, or where' Y, {* Y+ S: [! V$ l
a TOOL is needed but the instructions for use instruct any OPERATOR other than SERVICE+ O# h" z, v ^, S5 C4 R
PERSONNEL to open the relevant ACCESS COVER.
6 ^1 p3 O- i% h3 G( y' m0 n6 p5 e
( y+ G6 p4 J4 EEXAMPLE 1 Illuminated push-buttons
# g9 M( [0 d9 _! ?5 KEXAMPLE 2 Indicator lamps
" j& n9 v2 ]; r: Z: vEXAMPLE 3 Recorder pens
! ^9 b1 `) c9 V% L8 EEXAMPLE 4 Parts of plug-in modules0 ]4 ^6 i7 D, s2 ^* @8 k1 v
EXAMPLE 5 Batteries
9 D* F* n! K) C0 `9 W8 a' E$ x0 {& E
For such parts, the voltage to earth or to other ACCESSIBLE PARTS shall not exceed
4 |1 C! d" o' C" `! V42,4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. The d.c.
+ u+ N- Y3 |( q7 {limit of 60 V applies to d.c. with not more than 10 % peak-to-peak ripple. If the ripple, F# G" e' [7 T: G, U* v2 n
exceeds that amount, the 42,4 V peak limit applies. The energy shall not exceed 240 VA3 N0 J0 e4 c3 J
for longer than 60 s or the stored energy available shall not exceed 20 J at a potential up* p" p% J. ~6 d( L1 g, U
to 2 V.
# h# T+ V" o8 MNOTE If voltages higher than the limits specified in 8.4.2 c) are present, the LEAKAGE CURRENT limits referred- d+ }! H- y7 B" R1 d" e! ^! v
to in 8.4.2 b) apply.. n( i3 T, z8 ~0 A; k& Y6 F& w
7 C. \2 Q* B" }" q. ^
Compliance is checked by inspection of the RISK MANAGEMENT FILE, by reference to the
" s3 }: f- ~5 Sinstructions for use and by measurement.
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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
