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8.4 Limitation of voltage, current or energy
1 t; v2 G- N/ {2 v9 f3 H* M8.4.2 ACCESSIBLE PARTS including APPLIED PARTS
& ?, e/ w- s" l" O, ?6 P. n/ r( I( t..........................: P& \3 P0 N: _1 T& c
b) * The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT
, F, j' @" o: a; q* y& }5 ZCONNECTIONS shall not exceed the limits for TOUCH CURRENT specified in 8.7.3 c) when, V9 }/ ~6 h6 I9 Z2 a$ N6 I
measured as specified in 8.7.4.
. Q9 _& W* S4 |, e+ S1 W8 G) @/ Mc) * The limits specified in b) above do not apply to the following parts if the probability of a
7 f' B8 W5 ?* v- l8 p7 P" t; V. wconnection to a PATIENT, either directly or through the body of the OPERATOR, through which% B& [9 e( L* p% V* h
a current exceeding the allowable TOUCH CURRENT could flow, is negligible in NORMAL USE,7 ~+ s2 a: c; i U! }0 b1 |0 I
and the instructions for use instruct the OPERATOR not to touch the relevant part and the
$ e5 O9 \6 I8 P' F2 A* E+ k/ ZPATIENT simultaneously:
! i- ~3 y- J( L' Y
/ a B9 r% h9 X9 Z0 w# D– accessible contacts of connectors;6 w6 T, W# a& }
– contacts of fuseholders that are accessible during replacement of the fuse;
5 d% ]# Y" \) G/ Z+ L– contacts of lampholders that are accessible after removal of the lamp;5 t1 y' b) ~) U% f
– parts inside an ACCESS COVER that can be opened without the use of a TOOL, or where
9 e, F( B7 n9 K" i \$ x6 J* }a TOOL is needed but the instructions for use instruct any OPERATOR other than SERVICE: @3 \0 s# Z7 ]1 c! X& _
PERSONNEL to open the relevant ACCESS COVER.0 z- y% k9 K& j4 u
- X5 j8 u3 C9 C1 ?3 A vEXAMPLE 1 Illuminated push-buttons
- [- O o7 H- K# q5 }7 CEXAMPLE 2 Indicator lamps L W' L5 C k" O, G# K
EXAMPLE 3 Recorder pens
, d3 I8 X6 M, V* p ]- J+ yEXAMPLE 4 Parts of plug-in modules
/ r# b% ~9 n& Q( }$ eEXAMPLE 5 Batteries# u. T4 v2 h" _
4 Q- Y) T' z! w s4 Y
For such parts, the voltage to earth or to other ACCESSIBLE PARTS shall not exceed
, w0 i* C; J" ~4 V! T2 w( U42,4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. The d.c.
7 u3 f5 i5 \# w$ L4 E5 klimit of 60 V applies to d.c. with not more than 10 % peak-to-peak ripple. If the ripple9 R- Q4 @7 I, @# l: {
exceeds that amount, the 42,4 V peak limit applies. The energy shall not exceed 240 VA! n% f! T! g" ~( ?
for longer than 60 s or the stored energy available shall not exceed 20 J at a potential up
1 u" a# b4 g; X1 Vto 2 V.# ]" D" W3 `) }
NOTE If voltages higher than the limits specified in 8.4.2 c) are present, the LEAKAGE CURRENT limits referred& p% q; F3 u, A- l' b" f+ K
to in 8.4.2 b) apply.
0 X: t4 N, c- [4 {5 {1 y
, E0 L0 @! L! H2 D3 w5 Y9 CCompliance is checked by inspection of the RISK MANAGEMENT FILE, by reference to the
- u2 ?8 B6 S# G$ B3 a$ Binstructions for use and by measurement.
2 Z6 m3 C) Q6 [# c7 Z! b% ]( p7 ]2 I# `; t: E
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
