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8.4 Limitation of voltage, current or energy
, ~5 i$ {$ d0 d3 x; d1 ?' t8.4.2 ACCESSIBLE PARTS including APPLIED PARTS
& x: e; u% Y- |1 B' ?! {..........................
" @* v" E5 l& H5 [7 z1 e- mb) * The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT; p4 S9 B8 ? b2 M
CONNECTIONS shall not exceed the limits for TOUCH CURRENT specified in 8.7.3 c) when
) Y' x7 e, N) \: tmeasured as specified in 8.7.4.0 }. j H; y& h4 s0 S' s! J3 O4 d9 v5 I
c) * The limits specified in b) above do not apply to the following parts if the probability of a
. y( R+ Y: n* s( cconnection to a PATIENT, either directly or through the body of the OPERATOR, through which' _/ k0 K, p5 q! c( m7 A
a current exceeding the allowable TOUCH CURRENT could flow, is negligible in NORMAL USE,
@8 `8 K4 x6 d% z" W( Nand the instructions for use instruct the OPERATOR not to touch the relevant part and the
* W8 G E5 \- h+ Z. |/ H8 SPATIENT simultaneously:
. y% g3 r) C& a5 ~) s& ~" W6 ]' R4 m9 A& o+ t3 z
– accessible contacts of connectors;* i% x$ |! ^! H% }/ Z
– contacts of fuseholders that are accessible during replacement of the fuse;
" h5 P3 N1 Y& H+ i) e– contacts of lampholders that are accessible after removal of the lamp;
9 N" F; }6 d# l: U3 M# T– parts inside an ACCESS COVER that can be opened without the use of a TOOL, or where
( f+ E$ r. z6 ?0 R# Z0 [) Ya TOOL is needed but the instructions for use instruct any OPERATOR other than SERVICE- w: U5 p( w! ]
PERSONNEL to open the relevant ACCESS COVER.) ?5 E! W% j: e
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EXAMPLE 1 Illuminated push-buttons9 z- R0 s6 x2 Z6 ]- i
EXAMPLE 2 Indicator lamps
0 o9 u% \5 W$ r6 C: z- {6 t$ A; wEXAMPLE 3 Recorder pens. M R; Z: p% ^
EXAMPLE 4 Parts of plug-in modules# K3 f6 ] W; {/ g# B
EXAMPLE 5 Batteries+ a& V) `2 ~, P+ U5 a0 \! Y
7 d0 G9 ~; v/ S8 Q
For such parts, the voltage to earth or to other ACCESSIBLE PARTS shall not exceed
1 s: F* G) O' Z+ d1 z% l42,4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. The d.c.
) P: Q6 U' Z& t$ w8 }limit of 60 V applies to d.c. with not more than 10 % peak-to-peak ripple. If the ripple% s- q- V6 X; z) `0 o2 }
exceeds that amount, the 42,4 V peak limit applies. The energy shall not exceed 240 VA
( Q3 P" Z5 B3 m- S( I# B& Z2 ofor longer than 60 s or the stored energy available shall not exceed 20 J at a potential up+ q; H w' _* Q
to 2 V.
8 S: R9 ^4 `& y9 k3 z. pNOTE If voltages higher than the limits specified in 8.4.2 c) are present, the LEAKAGE CURRENT limits referred
4 ]9 m8 T8 v# `) v$ ]2 nto in 8.4.2 b) apply.4 \8 C' Z. N9 K
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Compliance is checked by inspection of the RISK MANAGEMENT FILE, by reference to the
1 W1 L- O' v! ?5 Z8 @ U( p V% n0 Qinstructions for use and by measurement.% M' j6 Y* K6 [% Z4 N5 a# E! H
) p p/ }% n+ f. W5 U( T, u
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
