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8.4 Limitation of voltage, current or energy
+ H& H% W: I: q, J i o. Q# G8.4.2 ACCESSIBLE PARTS including APPLIED PARTS
! f8 X! A; b/ H/ q..........................! h5 v9 ~ |1 v6 ^
b) * The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT* p7 Q7 \# W# U* w
CONNECTIONS shall not exceed the limits for TOUCH CURRENT specified in 8.7.3 c) when' }8 }" O* d* V- I7 ~
measured as specified in 8.7.4.$ A# U- v' c8 f7 r
c) * The limits specified in b) above do not apply to the following parts if the probability of a# K }6 e. _' c- I I/ |, ~
connection to a PATIENT, either directly or through the body of the OPERATOR, through which8 `1 U" _9 T! V0 b Q) s6 a
a current exceeding the allowable TOUCH CURRENT could flow, is negligible in NORMAL USE,
: T# x! f4 ^; ?$ e+ X: h; y# wand the instructions for use instruct the OPERATOR not to touch the relevant part and the
: g% ~8 j5 Z! F* hPATIENT simultaneously:; w$ ^. M( y* p+ G( U
* b0 R( U5 Q! }' y
– accessible contacts of connectors;
: L# [7 j& S& R( P! @$ `: G– contacts of fuseholders that are accessible during replacement of the fuse;4 ^ A p9 y- z5 ]
– contacts of lampholders that are accessible after removal of the lamp;3 s0 O) q9 a1 f+ W7 {
– parts inside an ACCESS COVER that can be opened without the use of a TOOL, or where
; j: z& p1 o9 r) \a TOOL is needed but the instructions for use instruct any OPERATOR other than SERVICE7 j- R7 j# h- K5 S5 P# v7 {
PERSONNEL to open the relevant ACCESS COVER.
4 L; x8 q- l, E2 ]# `
+ L; v3 ]# ?1 l9 iEXAMPLE 1 Illuminated push-buttons+ L z' o9 I; [5 x b" R" h7 ]) _
EXAMPLE 2 Indicator lamps& N2 D7 F% t7 a+ F" y; j) ?3 }# A
EXAMPLE 3 Recorder pens
3 W8 k& |5 L$ r. u1 h" T# HEXAMPLE 4 Parts of plug-in modules
: w& H7 x3 D( M( h6 z' DEXAMPLE 5 Batteries% s+ i& Y& J) c3 n6 t. i. v
4 w* q Q- p2 ]+ N7 VFor such parts, the voltage to earth or to other ACCESSIBLE PARTS shall not exceed
' R$ K! O* Y R+ Q/ m0 G0 d2 v5 S42,4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. The d.c.
! o. B9 t7 h! V" S0 D) mlimit of 60 V applies to d.c. with not more than 10 % peak-to-peak ripple. If the ripple8 o) w5 j; o1 u e2 J0 t
exceeds that amount, the 42,4 V peak limit applies. The energy shall not exceed 240 VA
" ?6 N# x0 D; E/ r- lfor longer than 60 s or the stored energy available shall not exceed 20 J at a potential up
3 a; y# s1 W9 pto 2 V.! l# y8 |5 I! u/ f
NOTE If voltages higher than the limits specified in 8.4.2 c) are present, the LEAKAGE CURRENT limits referred
# h2 s U& h- n& _' }. v" k0 lto in 8.4.2 b) apply.! X) }8 Y7 ^+ n
+ @8 g) [/ J7 n1 Y/ e9 e4 nCompliance is checked by inspection of the RISK MANAGEMENT FILE, by reference to the
. s( z) V2 |( o- B9 e( r0 F2 m+ Einstructions for use and by measurement.& z! P6 }, v$ d
1 V% `- n; b- R; E! M
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
