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8.4 Limitation of voltage, current or energy5 H. Z- b) r" p) N+ i% h
8.4.2 ACCESSIBLE PARTS including APPLIED PARTS
& u8 ]5 T( V7 P& s( r+ ?% \$ s, `..........................
2 n4 l4 t' t; F5 nb) * The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT
* w% A" B7 E0 @, m- G5 _8 O2 [CONNECTIONS shall not exceed the limits for TOUCH CURRENT specified in 8.7.3 c) when
: m+ N# K: {- s) ^- @4 C$ j! [$ nmeasured as specified in 8.7.4.$ P! n& p7 i. \' a
c) * The limits specified in b) above do not apply to the following parts if the probability of a6 L4 [' N4 O6 r4 A
connection to a PATIENT, either directly or through the body of the OPERATOR, through which# z* h4 ~4 Q) [4 q6 [/ Z
a current exceeding the allowable TOUCH CURRENT could flow, is negligible in NORMAL USE,
7 F4 H9 C. j: d( z& q$ rand the instructions for use instruct the OPERATOR not to touch the relevant part and the
: |5 \6 W5 X. MPATIENT simultaneously:, j3 |/ {, Q- I# H1 Z8 I
3 {; O% ?- M. I) y4 M, _
– accessible contacts of connectors;4 [1 ?! ^" C. }5 {8 `
– contacts of fuseholders that are accessible during replacement of the fuse;0 Y! E: v1 v+ P f8 ~5 q
– contacts of lampholders that are accessible after removal of the lamp;
* s5 @* ?% N( ^$ I/ P) Y* y1 z% j; Y– parts inside an ACCESS COVER that can be opened without the use of a TOOL, or where4 S1 l1 H+ x2 M1 t+ k
a TOOL is needed but the instructions for use instruct any OPERATOR other than SERVICE
) ?1 i0 ]+ W/ l& r$ lPERSONNEL to open the relevant ACCESS COVER.8 O- c L( Y, s
) K S4 W: f$ _$ X+ lEXAMPLE 1 Illuminated push-buttons
) h3 Z* m) r% |4 d5 pEXAMPLE 2 Indicator lamps7 L. i( L% N1 ?5 K5 Y( b# r: J
EXAMPLE 3 Recorder pens
2 q6 v6 O: n$ X; I% ]) `EXAMPLE 4 Parts of plug-in modules
& m1 X5 v" z: Y: lEXAMPLE 5 Batteries
! Q1 h; Q6 t4 E
$ [. k8 z9 P9 W) ~* \For such parts, the voltage to earth or to other ACCESSIBLE PARTS shall not exceed( U/ D# f# L# E* X1 j( W& ?
42,4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. The d.c.5 P. B0 h, D- K) i
limit of 60 V applies to d.c. with not more than 10 % peak-to-peak ripple. If the ripple
( L/ R5 e% E$ R% N1 jexceeds that amount, the 42,4 V peak limit applies. The energy shall not exceed 240 VA
* o3 h7 |) F9 d, ~2 E& Rfor longer than 60 s or the stored energy available shall not exceed 20 J at a potential up$ l+ z# y3 f$ b! l) }
to 2 V.$ ~' e+ c) M5 G
NOTE If voltages higher than the limits specified in 8.4.2 c) are present, the LEAKAGE CURRENT limits referred
$ {* I# Z- B6 n, zto in 8.4.2 b) apply.
- Z0 l; V/ o0 B1 u3 b/ @! |5 ?9 O- O9 b v h& d$ Z9 h
Compliance is checked by inspection of the RISK MANAGEMENT FILE, by reference to the
" L1 G/ \4 X9 Q5 minstructions for use and by measurement.* a1 s! ]* I& t5 G5 }
; x( i0 |1 a$ z; q( D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
