|
|
8.4 Limitation of voltage, current or energy* V7 W4 H4 y. E! ?3 _% i
8.4.2 ACCESSIBLE PARTS including APPLIED PARTS) E# z7 E/ [$ n. }& ~# Q) f
..........................
9 Q/ F) v* P L1 d! Y6 Xb) * The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT. t: A" V+ _ v p- g. R
CONNECTIONS shall not exceed the limits for TOUCH CURRENT specified in 8.7.3 c) when& P C9 t3 u* o/ R ]
measured as specified in 8.7.4.5 W) d1 F Q: I. g% k4 Y7 g
c) * The limits specified in b) above do not apply to the following parts if the probability of a& J: c$ x9 j: d: L: Y
connection to a PATIENT, either directly or through the body of the OPERATOR, through which
0 i1 `( L5 c6 la current exceeding the allowable TOUCH CURRENT could flow, is negligible in NORMAL USE,5 O) J I! ~" A; T7 @4 D2 ?2 s' O6 E, L
and the instructions for use instruct the OPERATOR not to touch the relevant part and the6 p, g, Z- q2 [9 A5 z l
PATIENT simultaneously:
& C+ ~& v- Z$ `+ }% w3 a) q
7 R* e9 P. q$ z: X' s– accessible contacts of connectors;
5 Y* S0 h+ _$ f" R- s* d– contacts of fuseholders that are accessible during replacement of the fuse;1 ~6 t3 B* \# q/ b1 W+ E
– contacts of lampholders that are accessible after removal of the lamp;+ S8 N1 o: \- f5 Z
– parts inside an ACCESS COVER that can be opened without the use of a TOOL, or where
7 u% T* b/ n/ e$ j; ^7 ra TOOL is needed but the instructions for use instruct any OPERATOR other than SERVICE
# ^& i5 R* b# d$ S5 e) n% wPERSONNEL to open the relevant ACCESS COVER." _( k/ Q. M$ W2 L( [0 C. ]
+ I7 R& z- G1 T+ S) p; xEXAMPLE 1 Illuminated push-buttons: Y& ^3 q/ [3 G- K5 r' `' s
EXAMPLE 2 Indicator lamps4 Z. \/ I+ C& Q8 G" C) H/ I
EXAMPLE 3 Recorder pens |& a2 i0 N5 Z! X+ A; ~+ L: `7 w
EXAMPLE 4 Parts of plug-in modules
$ f6 g# v4 @9 b! E: uEXAMPLE 5 Batteries, p. Z& G, u0 n2 A0 P
_2 {7 @! t/ O6 g! L
For such parts, the voltage to earth or to other ACCESSIBLE PARTS shall not exceed
2 o0 X4 q* g }" L+ Z$ C42,4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. The d.c.! D% y2 o, a0 {. ~& U9 C
limit of 60 V applies to d.c. with not more than 10 % peak-to-peak ripple. If the ripple
) ]5 c' Z$ c; R) A- qexceeds that amount, the 42,4 V peak limit applies. The energy shall not exceed 240 VA
" P. v" X: @2 P6 ofor longer than 60 s or the stored energy available shall not exceed 20 J at a potential up. E9 |# d8 k: O& t _3 o1 H; l
to 2 V.9 [2 o6 l; @3 D, I6 L
NOTE If voltages higher than the limits specified in 8.4.2 c) are present, the LEAKAGE CURRENT limits referred4 \- m" w6 Y5 S( v
to in 8.4.2 b) apply.
) _) o( a( s" b1 v! p* w, P3 B; }0 ?/ K# l4 Q& e
Compliance is checked by inspection of the RISK MANAGEMENT FILE, by reference to the# g( e7 c1 _" |9 N6 d T7 p
instructions for use and by measurement.
4 s {( ]! O, k4 \, G/ m
1 I7 r+ H- k; q) m% 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。 |
|