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8.4 Limitation of voltage, current or energy8 n6 Y a p- r+ N7 ?+ `3 a
8.4.2 ACCESSIBLE PARTS including APPLIED PARTS6 @! b* N- l) Y& x) M/ Y/ \ H; b1 x
..........................; \) W t, a& d. D' r- d' n
b) * The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT
1 u, P$ l4 N* `) p1 V8 F; pCONNECTIONS shall not exceed the limits for TOUCH CURRENT specified in 8.7.3 c) when4 u4 q* Z' `# |
measured as specified in 8.7.4.
4 C4 p' R3 V* W$ z3 t! {. n, oc) * The limits specified in b) above do not apply to the following parts if the probability of a
( j* V2 X \7 e% Oconnection to a PATIENT, either directly or through the body of the OPERATOR, through which& P9 a3 w7 A, n
a current exceeding the allowable TOUCH CURRENT could flow, is negligible in NORMAL USE,# Y* m+ t8 F( s4 _
and the instructions for use instruct the OPERATOR not to touch the relevant part and the5 C6 q* L2 x% j/ c# A
PATIENT simultaneously:
4 c; b9 l* C7 Z, K
% r4 h$ r" \6 w6 ?( x– accessible contacts of connectors;
! h$ |6 i' Y1 T! _– contacts of fuseholders that are accessible during replacement of the fuse;7 I0 T$ m+ ~( G
– contacts of lampholders that are accessible after removal of the lamp;
! N$ r1 z% }9 v7 d. M– parts inside an ACCESS COVER that can be opened without the use of a TOOL, or where/ } [+ n" p& ~2 M6 Q* f
a TOOL is needed but the instructions for use instruct any OPERATOR other than SERVICE2 ~7 G5 V! j& |: q$ [+ i& D; _2 ]
PERSONNEL to open the relevant ACCESS COVER., i1 g# \- f2 A# T! ]4 r
$ g7 I0 z3 ^; V
EXAMPLE 1 Illuminated push-buttons) w9 v7 K- h" e& \- B
EXAMPLE 2 Indicator lamps
' I; `* F0 h' }8 V( c* S A CEXAMPLE 3 Recorder pens. B# c& f! L. H. ?7 H: X/ W ^- A2 x
EXAMPLE 4 Parts of plug-in modules
$ o; l ^! I$ d; c4 g) {EXAMPLE 5 Batteries* g' [3 b! W% e u* S$ o" c
9 s9 {9 ^, t6 Y0 w4 FFor such parts, the voltage to earth or to other ACCESSIBLE PARTS shall not exceed$ P! m3 f9 u+ y8 ^3 L/ h4 u
42,4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. The d.c." S9 m3 C: z; M' o3 A; c7 m
limit of 60 V applies to d.c. with not more than 10 % peak-to-peak ripple. If the ripple4 g& y( @0 e& m2 f& ~+ Y/ ]
exceeds that amount, the 42,4 V peak limit applies. The energy shall not exceed 240 VA
4 v( c- B# _ ]1 A) e0 ffor longer than 60 s or the stored energy available shall not exceed 20 J at a potential up8 V& t0 P% L0 f: A+ o* h' ?
to 2 V.+ } z4 Q: m* n. h3 r. e. X
NOTE If voltages higher than the limits specified in 8.4.2 c) are present, the LEAKAGE CURRENT limits referred
; |, c q, U) P- L" {) O2 jto in 8.4.2 b) apply.( ]+ V( {1 T5 [7 X5 X
& }" A7 o5 v6 E/ b4 Z8 d) n$ X/ Z
Compliance is checked by inspection of the RISK MANAGEMENT FILE, by reference to the
, }: Q8 j9 v7 c6 u! ]2 o/ I6 finstructions for use and by measurement.
- e$ x' u8 h/ ^" Y& b0 n7 k
& c8 D+ Q& W+ @" k# f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
