|
|
8.4 Limitation of voltage, current or energy9 f, _! N: K5 R' o. s
8.4.2 ACCESSIBLE PARTS including APPLIED PARTS
2 E) [# f+ I( A: J.........................." N$ f7 z x$ @6 o8 Z0 p( k' i
b) * The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT
6 D; c* I7 S0 d# _+ z# OCONNECTIONS shall not exceed the limits for TOUCH CURRENT specified in 8.7.3 c) when
, d& \; S3 r, ymeasured as specified in 8.7.4.
' m5 V, x4 Q. D7 ic) * The limits specified in b) above do not apply to the following parts if the probability of a+ _( u0 {; r, b5 R5 T
connection to a PATIENT, either directly or through the body of the OPERATOR, through which
) B0 U! ]/ D# t5 u8 E5 ~4 D" D& ^a current exceeding the allowable TOUCH CURRENT could flow, is negligible in NORMAL USE,( z0 j0 }0 i; B- e! ]% |
and the instructions for use instruct the OPERATOR not to touch the relevant part and the
- U! @+ V+ ~ J. r" ~! Y, JPATIENT simultaneously:$ P( m# V' \; w6 `
) c! _, _" U$ O) f
– accessible contacts of connectors;
0 \2 n1 \) O( K– contacts of fuseholders that are accessible during replacement of the fuse;' {2 U n: V, |
– contacts of lampholders that are accessible after removal of the lamp;8 z' p& Y( n: x8 k
– parts inside an ACCESS COVER that can be opened without the use of a TOOL, or where. N" X6 M" m [1 G- F4 z
a TOOL is needed but the instructions for use instruct any OPERATOR other than SERVICE5 d: b% t% I% x+ L8 |0 j# G3 K
PERSONNEL to open the relevant ACCESS COVER.
$ w+ h" i& ]! O, d5 f' x: L( O$ S) A! Y7 O7 b: I+ h6 F
EXAMPLE 1 Illuminated push-buttons6 u" K8 d) ~( {$ |; T" B
EXAMPLE 2 Indicator lamps/ n$ b/ i( @& i( q' k- c
EXAMPLE 3 Recorder pens3 y* A' o0 M& N1 M, e0 q
EXAMPLE 4 Parts of plug-in modules B+ h8 _$ e1 N7 R
EXAMPLE 5 Batteries
* j# R) p9 s" h* m# O$ ], D" ~% }' {5 N
For such parts, the voltage to earth or to other ACCESSIBLE PARTS shall not exceed, D% ~0 U- ?) z, b( {
42,4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. The d.c.
2 P/ Z5 ], r% x7 U. Qlimit of 60 V applies to d.c. with not more than 10 % peak-to-peak ripple. If the ripple
/ W g6 j, f9 {2 Q) n5 \' Mexceeds that amount, the 42,4 V peak limit applies. The energy shall not exceed 240 VA8 C7 k( q* {8 z; Q$ D9 r
for longer than 60 s or the stored energy available shall not exceed 20 J at a potential up) u, c. ? Q. |# W3 @" O& k
to 2 V.5 N( J* ^' v$ u$ ^8 ~
NOTE If voltages higher than the limits specified in 8.4.2 c) are present, the LEAKAGE CURRENT limits referred g4 w1 I, F% v7 W+ d0 V
to in 8.4.2 b) apply.0 f0 t/ t& g. c0 l! I' w
" e! ~' V# p# L6 o4 D
Compliance is checked by inspection of the RISK MANAGEMENT FILE, by reference to the
- X7 j5 G! k/ Sinstructions for use and by measurement. j9 L8 U Z6 F" f$ u) J
5 Y' c$ w y w% K7 \3 @/ U0 v 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。 |
|
|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
