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8.4 Limitation of voltage, current or energy
# p& |" f0 J: O6 B' |$ l9 d8.4.2 ACCESSIBLE PARTS including APPLIED PARTS
' f7 {" s6 {" Q `" ]) l5 a..........................
* t0 {8 l' w, n0 S& rb) * The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT4 d: \4 G; T, v# H$ Y x
CONNECTIONS shall not exceed the limits for TOUCH CURRENT specified in 8.7.3 c) when
1 U9 \$ S) m; @& X2 \9 cmeasured as specified in 8.7.4.' F. ^' I$ p% Y
c) * The limits specified in b) above do not apply to the following parts if the probability of a ^7 V: { i0 c! P8 g _
connection to a PATIENT, either directly or through the body of the OPERATOR, through which
4 h; r+ }) U$ d% u9 W" R. ua current exceeding the allowable TOUCH CURRENT could flow, is negligible in NORMAL USE,
$ G4 c, Z" y( v# F# _. d8 _and the instructions for use instruct the OPERATOR not to touch the relevant part and the7 J, n" {$ Z: s9 c
PATIENT simultaneously:
) g6 \! d! W. `' d
0 l$ n- G' a3 v8 |+ l– accessible contacts of connectors;
" Z/ a+ v- Y A8 C" @$ C4 I4 q– contacts of fuseholders that are accessible during replacement of the fuse;/ U# V3 y( ] ` z6 e
– contacts of lampholders that are accessible after removal of the lamp;
7 {6 O1 |% T* s) Z1 z- P1 r+ F– parts inside an ACCESS COVER that can be opened without the use of a TOOL, or where
5 m. j* E% H5 m; }% Ka TOOL is needed but the instructions for use instruct any OPERATOR other than SERVICE
, t0 h) X% L5 F9 Z# YPERSONNEL to open the relevant ACCESS COVER.8 V: Y, o3 U; S% M
( [$ {8 K4 a' e# v KEXAMPLE 1 Illuminated push-buttons
5 F9 v( O. [; i* ?) NEXAMPLE 2 Indicator lamps% z2 \9 N( B; R$ W! ^; J
EXAMPLE 3 Recorder pens- E. A' G0 E, E1 M( F
EXAMPLE 4 Parts of plug-in modules
# G! t7 M4 @. A& ?) hEXAMPLE 5 Batteries
2 [% I0 H, i$ c% I1 j8 f; R7 D+ q+ s6 q' P k2 i% p" I y
For such parts, the voltage to earth or to other ACCESSIBLE PARTS shall not exceed/ W. T0 a4 h& q
42,4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. The d.c.. L" {+ I6 s5 |$ [* v
limit of 60 V applies to d.c. with not more than 10 % peak-to-peak ripple. If the ripple
5 d6 A2 f* ~3 Q* hexceeds that amount, the 42,4 V peak limit applies. The energy shall not exceed 240 VA
# a( ~1 D) J6 ifor longer than 60 s or the stored energy available shall not exceed 20 J at a potential up
/ g- e& N2 p& p- @# ^1 c* |to 2 V.1 P3 L- l+ u3 E! @! J1 K
NOTE If voltages higher than the limits specified in 8.4.2 c) are present, the LEAKAGE CURRENT limits referred
" Z1 R8 G3 { W+ |to in 8.4.2 b) apply.
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Compliance is checked by inspection of the RISK MANAGEMENT FILE, by reference to the6 d" x, I. h. v# @- _! B
instructions for use and by measurement.
# U! s: M* @% q! D( y
6 k$ D4 {2 d! |! j% }2 _! g, e- o; L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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