|
|
8.4 Limitation of voltage, current or energy
9 Z& ]# k6 I' e3 {/ ?1 l, N8.4.2 ACCESSIBLE PARTS including APPLIED PARTS
5 d5 i* {7 o- h..........................
, Y/ H2 i$ Y$ t; Bb) * The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT3 F; O4 C8 q _
CONNECTIONS shall not exceed the limits for TOUCH CURRENT specified in 8.7.3 c) when
h) e% u3 p9 |. |0 t8 A! x8 w$ Emeasured as specified in 8.7.4.1 \" a- @9 `6 z/ _* d2 K
c) * The limits specified in b) above do not apply to the following parts if the probability of a) Z) S* h2 D& w8 _0 ?$ @$ ~$ j
connection to a PATIENT, either directly or through the body of the OPERATOR, through which* w! V) K" y) E" a$ d8 w
a current exceeding the allowable TOUCH CURRENT could flow, is negligible in NORMAL USE,
" D2 n8 S- C0 C; Kand the instructions for use instruct the OPERATOR not to touch the relevant part and the
5 u3 n+ t/ Z% N& nPATIENT simultaneously:
) w4 |, s5 U* S- B1 K8 V: _3 R* h, e, f7 \7 \/ T6 [7 R
– accessible contacts of connectors;5 a4 x/ V: R0 Q2 L/ n- g7 |- d
– contacts of fuseholders that are accessible during replacement of the fuse;
' Q0 Q! E; F5 c4 R% x0 J. `– contacts of lampholders that are accessible after removal of the lamp;: U+ i4 B, F, n' N$ V6 j- \
– parts inside an ACCESS COVER that can be opened without the use of a TOOL, or where
3 G* K0 s# ]$ c/ x/ c/ _$ ya TOOL is needed but the instructions for use instruct any OPERATOR other than SERVICE) C5 r# `" o, n9 M2 t0 z
PERSONNEL to open the relevant ACCESS COVER.
- d. ?0 E& }; d
. ?6 H) f0 y" u7 D/ O. hEXAMPLE 1 Illuminated push-buttons
) G4 @ v3 r8 C3 S9 {! z4 NEXAMPLE 2 Indicator lamps
( n: N2 e. g. m: M4 FEXAMPLE 3 Recorder pens, u, V+ ^4 L0 L" n; Z1 ]* `3 S
EXAMPLE 4 Parts of plug-in modules
3 J6 `) |& E' P3 I' `( qEXAMPLE 5 Batteries6 L0 S& M+ @) Q0 u
! e* e+ E1 }/ _) f
For such parts, the voltage to earth or to other ACCESSIBLE PARTS shall not exceed8 g$ R1 U; \# u7 i/ D9 M
42,4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. The d.c.9 A- A, j1 M3 X/ o
limit of 60 V applies to d.c. with not more than 10 % peak-to-peak ripple. If the ripple
( ~: a1 u/ J# m! jexceeds that amount, the 42,4 V peak limit applies. The energy shall not exceed 240 VA
- a, M& n4 [8 q+ o: c9 `for longer than 60 s or the stored energy available shall not exceed 20 J at a potential up
$ M+ i7 `/ f* E0 [! Sto 2 V.1 p1 W) `4 O5 p* g7 i2 F* q; P
NOTE If voltages higher than the limits specified in 8.4.2 c) are present, the LEAKAGE CURRENT limits referred* h2 `+ m3 K, @0 z( @
to in 8.4.2 b) apply.) s+ q0 a( S8 l. A
$ G2 c/ ?5 [& p
Compliance is checked by inspection of the RISK MANAGEMENT FILE, by reference to the
, F, x4 l5 e8 |) ^instructions for use and by measurement.# G6 D7 ?- T) \; V+ i# P3 R; u7 }
D- l: R6 q$ A$ b) W* B4 q* z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。 |
|
|关于安规|小黑屋|安规QQ群|Archiver|手机版|安规网
( 粤ICP13023453-10 )
窥视卡
雷达卡
楼主
显身卡
发表于 2008-10-30 17:35
