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8.4 Limitation of voltage, current or energy% M0 }- H. n5 z1 \+ V2 Q
8.4.2 ACCESSIBLE PARTS including APPLIED PARTS
5 P- I: Z7 H! {6 b0 Y..........................: Y* l2 ^" ? S
b) * The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT' b- J% r# q! L; q4 Z1 j
CONNECTIONS shall not exceed the limits for TOUCH CURRENT specified in 8.7.3 c) when5 q( B/ N; S W. d" z. j* J9 V
measured as specified in 8.7.4.7 p/ l) \. f) ~* F
c) * The limits specified in b) above do not apply to the following parts if the probability of a8 c( a! l) o0 Q: v2 _) h. t) ^
connection to a PATIENT, either directly or through the body of the OPERATOR, through which
4 k) q! ~# J! z1 B& pa current exceeding the allowable TOUCH CURRENT could flow, is negligible in NORMAL USE,
F. W$ r9 k1 m+ K: i4 q) L0 ?and the instructions for use instruct the OPERATOR not to touch the relevant part and the" @& @. {" T8 o. I. n# B8 l- Q
PATIENT simultaneously:
5 }! O0 {: W% i3 R. @9 I# E$ e1 {
7 J' ^2 _/ T; l2 f ?% o' P– accessible contacts of connectors;
( w7 o: A# h: R! k) |– contacts of fuseholders that are accessible during replacement of the fuse;* F* }5 U: i8 y7 o2 j
– contacts of lampholders that are accessible after removal of the lamp;
5 b8 j. Q8 `' y– parts inside an ACCESS COVER that can be opened without the use of a TOOL, or where
0 q: e3 E# H0 _$ x+ ha TOOL is needed but the instructions for use instruct any OPERATOR other than SERVICE9 v4 V5 `% |: h( s
PERSONNEL to open the relevant ACCESS COVER.4 p6 U* y" r1 A) ?
& {6 J5 ^* X4 Z& tEXAMPLE 1 Illuminated push-buttons2 Q) ~+ {; r# G
EXAMPLE 2 Indicator lamps/ v" r- R$ A: U+ D
EXAMPLE 3 Recorder pens5 ]: m+ C ^0 Q
EXAMPLE 4 Parts of plug-in modules S0 R0 d' w$ H9 t% f# ?$ e8 G
EXAMPLE 5 Batteries
; M6 w: O, h0 \: b" x1 R5 G! r$ r, _# ?! X+ D
For such parts, the voltage to earth or to other ACCESSIBLE PARTS shall not exceed
9 H6 n1 j" A& ?0 V7 N1 m5 P42,4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. The d.c.( q* D: j8 @8 _5 e* j
limit of 60 V applies to d.c. with not more than 10 % peak-to-peak ripple. If the ripple8 ^5 z: F6 \/ a, G
exceeds that amount, the 42,4 V peak limit applies. The energy shall not exceed 240 VA
' L! c) g8 L3 ^: pfor longer than 60 s or the stored energy available shall not exceed 20 J at a potential up
8 j' C8 i! q7 o: A T2 A: a0 cto 2 V.
: d0 w' g0 V; r7 n3 F3 PNOTE If voltages higher than the limits specified in 8.4.2 c) are present, the LEAKAGE CURRENT limits referred# X/ R8 k: a4 U. X: u+ J# p# n
to in 8.4.2 b) apply.# @$ R C% ~0 G- J: ]
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Compliance is checked by inspection of the RISK MANAGEMENT FILE, by reference to the
! t' ], ~& n x) `6 t2 Binstructions for use and by measurement.5 G) U# ?- v( B0 y# M
, I* C d2 B% 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
