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8.4 Limitation of voltage, current or energy
# B" ]5 @% a! U: F; \3 P+ P8.4.2 ACCESSIBLE PARTS including APPLIED PARTS
5 h+ k/ i/ L- D& c..........................* I3 u* D. D6 y& v- N% G
b) * The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT
1 v- d( W# O5 H \CONNECTIONS shall not exceed the limits for TOUCH CURRENT specified in 8.7.3 c) when
( I% Q4 s& ]6 {( {" Y* Fmeasured as specified in 8.7.4.
+ L$ W" @# ~* i" H4 m. _( p% Lc) * The limits specified in b) above do not apply to the following parts if the probability of a
- p* V# S3 p4 O" n* \connection to a PATIENT, either directly or through the body of the OPERATOR, through which
6 s- H% u( L# E0 j. Da current exceeding the allowable TOUCH CURRENT could flow, is negligible in NORMAL USE,' J C) G4 b+ R! J! A* r3 L2 y
and the instructions for use instruct the OPERATOR not to touch the relevant part and the
2 j; y, X. n! ]! _* s4 kPATIENT simultaneously:
5 F3 I, @ J4 P4 A9 C. K- I0 d8 c/ D
K* x2 Z# _4 n- J. k6 ^( |– accessible contacts of connectors;
; Q2 U5 r, T# H( p9 g– contacts of fuseholders that are accessible during replacement of the fuse;
8 ]6 Y% ?4 }: p( l! O– contacts of lampholders that are accessible after removal of the lamp;% A/ W5 N5 l$ q9 |. M
– parts inside an ACCESS COVER that can be opened without the use of a TOOL, or where7 M. z2 v2 W* ~6 Z* b' ]8 Q% E4 b
a TOOL is needed but the instructions for use instruct any OPERATOR other than SERVICE
8 n( H3 }; J- P7 p; Z. S, `PERSONNEL to open the relevant ACCESS COVER.
5 H3 P3 r- w4 @/ b8 W/ x# b' A+ A; {+ J$ i4 C' h
EXAMPLE 1 Illuminated push-buttons# P8 k" z) j, X- p
EXAMPLE 2 Indicator lamps5 w+ |: i8 S. S
EXAMPLE 3 Recorder pens
+ c! b8 I, h) m- M4 G1 X" JEXAMPLE 4 Parts of plug-in modules0 }* @: }* r O8 g2 _
EXAMPLE 5 Batteries& l7 ~/ j/ e$ n' j/ b& C
( X( [% B3 \0 g( h+ J% `% BFor such parts, the voltage to earth or to other ACCESSIBLE PARTS shall not exceed2 o+ w5 A* |2 f W8 @
42,4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. The d.c. d( g& v% R- i# D$ v% ~8 ]
limit of 60 V applies to d.c. with not more than 10 % peak-to-peak ripple. If the ripple2 }: f8 S/ H- s( p# |
exceeds that amount, the 42,4 V peak limit applies. The energy shall not exceed 240 VA" |9 Y: [: @* C# u; Y- ?( _
for longer than 60 s or the stored energy available shall not exceed 20 J at a potential up
) p: K9 h' ^1 z2 M5 w/ B% Ito 2 V.2 x/ g2 F8 p2 V7 ^; d0 |. T
NOTE If voltages higher than the limits specified in 8.4.2 c) are present, the LEAKAGE CURRENT limits referred
, x2 t# @4 I2 {3 [to in 8.4.2 b) apply.& p4 H) p8 b$ |
1 n/ F5 a% o' t% D0 OCompliance is checked by inspection of the RISK MANAGEMENT FILE, by reference to the
9 |3 S# k4 _0 y' ?! Q& g0 Vinstructions for use and by measurement.. V1 f' v- z! [$ _& N. G. P
6 l; p* J( h2 Z" Q
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
