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8.4 Limitation of voltage, current or energy. N5 Z+ f5 w" M" a" [8 r, s" ^
8.4.2 ACCESSIBLE PARTS including APPLIED PARTS4 A, R* K/ s9 W" n& F5 b
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! K5 f9 E# _7 `% ^b) * The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT# G% G. _2 j: [; n0 m; M8 a+ _
CONNECTIONS shall not exceed the limits for TOUCH CURRENT specified in 8.7.3 c) when4 d9 X6 r# D. k
measured as specified in 8.7.4.
9 r3 t4 I" i7 h4 S jc) * The limits specified in b) above do not apply to the following parts if the probability of a
/ p+ _: Q ~, Z, ]+ f' V! y! uconnection to a PATIENT, either directly or through the body of the OPERATOR, through which; m3 S. t6 d1 ~3 X4 X' Z: ]
a current exceeding the allowable TOUCH CURRENT could flow, is negligible in NORMAL USE,
; \, k7 g6 D3 g+ hand the instructions for use instruct the OPERATOR not to touch the relevant part and the6 R" V+ d2 X2 x( d$ p0 q
PATIENT simultaneously:
6 e9 o5 g( t0 g7 H0 t6 \6 c
! t3 x. V$ G: g' |2 Y" N– accessible contacts of connectors;
8 ?* o3 F9 ]6 w* h. h– contacts of fuseholders that are accessible during replacement of the fuse;; I1 ^) n. l% D$ o8 ^" W
– contacts of lampholders that are accessible after removal of the lamp;7 I9 M) y U. e4 C- o
– parts inside an ACCESS COVER that can be opened without the use of a TOOL, or where; c. t! T. U( c3 k1 i. _4 v
a TOOL is needed but the instructions for use instruct any OPERATOR other than SERVICE% {: j0 z+ I# I! z5 A
PERSONNEL to open the relevant ACCESS COVER.
6 x$ l$ Q% ^- I& l2 l) b& c6 V: o
0 i. G. F% F# GEXAMPLE 1 Illuminated push-buttons
' P7 e$ u3 `9 A8 V. z f. s9 MEXAMPLE 2 Indicator lamps
! }4 L( I2 Q8 c6 Q7 b' f8 uEXAMPLE 3 Recorder pens$ R9 p: a6 b# Z3 Z' x
EXAMPLE 4 Parts of plug-in modules6 M5 Q4 u2 t7 {
EXAMPLE 5 Batteries3 ]! _0 ~2 Q7 q, j9 e- _& r! z
+ b8 b) f" F- O9 |( U0 s2 x, F& r1 p7 ^For such parts, the voltage to earth or to other ACCESSIBLE PARTS shall not exceed
/ q1 B' V" U9 R$ q& a42,4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. The d.c. R d& t) G% [2 J" D r+ a
limit of 60 V applies to d.c. with not more than 10 % peak-to-peak ripple. If the ripple' l% U' H1 a2 r: p
exceeds that amount, the 42,4 V peak limit applies. The energy shall not exceed 240 VA
( J6 r" J7 z* Y% Y$ M; H% U8 Afor longer than 60 s or the stored energy available shall not exceed 20 J at a potential up
/ A8 J( R5 k9 l! m% Ato 2 V.
1 Z* O6 ]) x dNOTE If voltages higher than the limits specified in 8.4.2 c) are present, the LEAKAGE CURRENT limits referred6 v/ R; F" N c8 i0 T4 S& s E; m, x0 v
to in 8.4.2 b) apply.
) X3 j: d; s4 M: t, R* r9 R( z% _- j( R6 M
Compliance is checked by inspection of the RISK MANAGEMENT FILE, by reference to the) [+ _' f# j, E% c
instructions for use and by measurement.
+ h9 ]) a0 g! V: p" H( X2 d, g
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
