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8.4 Limitation of voltage, current or energy
4 p3 y O c1 E4 B0 {8.4.2 ACCESSIBLE PARTS including APPLIED PARTS3 [& y6 H# m2 Q. E! P
..........................9 D% e) R" \4 T. J
b) * The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT
2 S: ?; _9 E! Z5 i6 JCONNECTIONS shall not exceed the limits for TOUCH CURRENT specified in 8.7.3 c) when
, Z1 t7 X' D2 [measured as specified in 8.7.4.0 p+ M! Z, ?" @4 I& _' w
c) * The limits specified in b) above do not apply to the following parts if the probability of a) Y$ V& |! b0 e0 q
connection to a PATIENT, either directly or through the body of the OPERATOR, through which
& U" w2 G5 O T( D6 {0 B: O9 Ba current exceeding the allowable TOUCH CURRENT could flow, is negligible in NORMAL USE,
; _* I6 Y6 ?5 y8 s" H+ q6 h( Yand the instructions for use instruct the OPERATOR not to touch the relevant part and the
+ t% t6 f% @% V0 H+ b9 \ \PATIENT simultaneously:/ l, J' t0 Q# {% m# d
4 t$ e( _% L; z; n
– accessible contacts of connectors;; j \7 n/ A. F. s* N& R
– contacts of fuseholders that are accessible during replacement of the fuse;$ q# M, I4 M" U
– contacts of lampholders that are accessible after removal of the lamp;. g/ N5 ]1 Q8 _/ n
– parts inside an ACCESS COVER that can be opened without the use of a TOOL, or where
' o( L( Y+ k3 v& o2 w/ Ea TOOL is needed but the instructions for use instruct any OPERATOR other than SERVICE
! Q& |2 H/ }0 DPERSONNEL to open the relevant ACCESS COVER.- y2 N- z7 M! r! C' O+ t4 @
' q. R4 R/ c9 N3 rEXAMPLE 1 Illuminated push-buttons8 U1 u8 b: }% Q, B& s
EXAMPLE 2 Indicator lamps
* k- u# i0 d* b8 u$ a }EXAMPLE 3 Recorder pens- q) b" Z& p! h$ y7 B0 L' V8 C
EXAMPLE 4 Parts of plug-in modules! h3 S+ C6 T3 X$ f' b4 e
EXAMPLE 5 Batteries
# ~4 k" T( S+ O. ~ X' Y) H
+ T( c9 X9 L4 {6 O& \For such parts, the voltage to earth or to other ACCESSIBLE PARTS shall not exceed& q7 d) p4 H4 j# O1 F! w8 B
42,4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. The d.c.
! W4 T) P7 Y6 h7 j& H; F d$ Blimit of 60 V applies to d.c. with not more than 10 % peak-to-peak ripple. If the ripple
2 {4 b7 q- ~. g% \+ wexceeds that amount, the 42,4 V peak limit applies. The energy shall not exceed 240 VA: w6 m2 w; Y' T7 e0 J
for longer than 60 s or the stored energy available shall not exceed 20 J at a potential up
4 C. H, E9 s" y2 Q7 Q1 Q, Yto 2 V.
, }. t9 G- Q' Y: W' s2 w0 I7 vNOTE If voltages higher than the limits specified in 8.4.2 c) are present, the LEAKAGE CURRENT limits referred
) e% L2 y* D) U/ Z C3 ?$ x& X& oto in 8.4.2 b) apply.
9 L3 P& l9 a+ _
) m: A" K: c' A9 z# q: J4 C( S7 LCompliance is checked by inspection of the RISK MANAGEMENT FILE, by reference to the1 S1 O0 z2 ]) ^ V, ~* B% i3 Q! D
instructions for use and by measurement.1 P" |* Z8 v( z5 Z
. {' a* \ y5 D' ^! X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
