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8.4 Limitation of voltage, current or energy
; }8 {1 @( t4 p" z3 L4 H3 m8.4.2 ACCESSIBLE PARTS including APPLIED PARTS
9 c6 Z9 ]) w7 ^# @5 }+ ^..........................
$ \" G6 h/ }& f1 H* Bb) * The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT
& O' Y& }( f" FCONNECTIONS shall not exceed the limits for TOUCH CURRENT specified in 8.7.3 c) when2 }" d& O5 {( S6 |- {+ w3 f2 k. D
measured as specified in 8.7.4.
2 k2 a' h& K9 |2 o. [" cc) * The limits specified in b) above do not apply to the following parts if the probability of a
- T) M, F: S/ p9 H# Q* Mconnection to a PATIENT, either directly or through the body of the OPERATOR, through which
S8 Z" {( P0 e5 n u! B5 ?, {a current exceeding the allowable TOUCH CURRENT could flow, is negligible in NORMAL USE,
( i2 F7 B) o' |/ X7 Xand the instructions for use instruct the OPERATOR not to touch the relevant part and the
) X! ^0 @$ V6 XPATIENT simultaneously:
, {6 a* `- s& L8 J. `% Z4 ]( w: m* p1 c: V
– accessible contacts of connectors;
1 _0 t, k& t: {$ o0 w; z: \5 [– contacts of fuseholders that are accessible during replacement of the fuse;
9 h$ Q5 Z' F6 I0 i6 C4 Q* n% u% @( e0 X– contacts of lampholders that are accessible after removal of the lamp;
$ x9 Z+ _, @# t/ G$ q- ]– parts inside an ACCESS COVER that can be opened without the use of a TOOL, or where
% a: F% s! F) A+ qa TOOL is needed but the instructions for use instruct any OPERATOR other than SERVICE
$ n; L- a4 m7 M! q TPERSONNEL to open the relevant ACCESS COVER.
+ c9 X* x( M) ]: m+ |8 Q) Y7 u! I
, ]) n# ~3 Y0 w+ G4 E9 t& R/ {EXAMPLE 1 Illuminated push-buttons
. S4 M: w2 b' |EXAMPLE 2 Indicator lamps% u1 s* @% U+ x
EXAMPLE 3 Recorder pens
9 E/ D9 A9 F+ J6 \/ w L: dEXAMPLE 4 Parts of plug-in modules4 e( E! }( M# Q, m( s$ h
EXAMPLE 5 Batteries% a1 f: U4 V# o5 }
+ e, d* w& R% f9 n4 K
For such parts, the voltage to earth or to other ACCESSIBLE PARTS shall not exceed9 v( n( a2 A, f- ^; e
42,4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. The d.c.
' g' E8 o$ l, M: mlimit of 60 V applies to d.c. with not more than 10 % peak-to-peak ripple. If the ripple7 R7 d0 l# r Q' ^1 @2 n2 S
exceeds that amount, the 42,4 V peak limit applies. The energy shall not exceed 240 VA) m, j/ H3 N; Y( w) W- S4 d$ p. U+ ~
for longer than 60 s or the stored energy available shall not exceed 20 J at a potential up L+ ?$ e8 I0 o. }0 a" Q* o
to 2 V.5 ?/ Y# X; j! c3 M, O' q6 D; ^
NOTE If voltages higher than the limits specified in 8.4.2 c) are present, the LEAKAGE CURRENT limits referred
+ v8 z5 e% @4 pto in 8.4.2 b) apply.
7 f1 V5 w/ L' }( Y1 N" `
% l/ W' f- }9 x, K# w+ `! |! ECompliance is checked by inspection of the RISK MANAGEMENT FILE, by reference to the
/ s, h2 j$ J$ {" j7 Sinstructions for use and by measurement.
. A, T2 u6 l. M) N
/ B0 v1 K/ \* @% z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
