|
|
8.4 Limitation of voltage, current or energy
9 b& g8 [2 c7 }$ d- T8.4.2 ACCESSIBLE PARTS including APPLIED PARTS3 @3 t* \7 n2 h0 q3 W
..........................) D5 Z! s# Z1 z0 D5 J
b) * The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT2 D6 A' m8 B) `" l3 a4 o
CONNECTIONS shall not exceed the limits for TOUCH CURRENT specified in 8.7.3 c) when1 [" ?# G1 R. `2 ~4 `
measured as specified in 8.7.4., b X6 w( {; {% A3 \7 |8 }
c) * The limits specified in b) above do not apply to the following parts if the probability of a% s" ~' @' S& q) y' W K9 t
connection to a PATIENT, either directly or through the body of the OPERATOR, through which6 L- i( i2 x# C# z
a current exceeding the allowable TOUCH CURRENT could flow, is negligible in NORMAL USE,
' B! t5 ?$ u3 ]9 l' t9 jand the instructions for use instruct the OPERATOR not to touch the relevant part and the8 y. O' Q/ s: Y/ y& m: X) m
PATIENT simultaneously:: ?" v8 ^) ?' J) V6 V$ ]
" O* Q1 p# c3 p: R0 \* W– accessible contacts of connectors;* F$ ~8 X5 n% V3 |$ S/ `
– contacts of fuseholders that are accessible during replacement of the fuse;5 L3 p2 f q) W1 J8 \% S- x
– contacts of lampholders that are accessible after removal of the lamp;, k1 X0 n2 w1 W: y
– parts inside an ACCESS COVER that can be opened without the use of a TOOL, or where
% M' @ F: Y2 k3 D7 Ja TOOL is needed but the instructions for use instruct any OPERATOR other than SERVICE7 B5 I0 O# `" g
PERSONNEL to open the relevant ACCESS COVER.$ M8 z: l7 _2 S- A; i
, V9 {. K8 X: HEXAMPLE 1 Illuminated push-buttons
/ z) _+ J( x. t6 i; UEXAMPLE 2 Indicator lamps' Z' X* T7 `0 Z
EXAMPLE 3 Recorder pens
% O* n3 x2 h( q% R- uEXAMPLE 4 Parts of plug-in modules9 y" s' o: u4 }6 Y
EXAMPLE 5 Batteries! U/ e5 o2 V) o' u# \% ~. n
& O6 G& g0 t' a& s Q
For such parts, the voltage to earth or to other ACCESSIBLE PARTS shall not exceed1 @8 w+ H+ I6 K% o4 q
42,4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. The d.c.
4 u$ _+ b: y7 G# y$ Climit of 60 V applies to d.c. with not more than 10 % peak-to-peak ripple. If the ripple
, z9 C S8 r! \/ S/ j0 o6 Texceeds that amount, the 42,4 V peak limit applies. The energy shall not exceed 240 VA! W3 K+ M9 }4 `$ O9 T3 C6 \5 K* n
for longer than 60 s or the stored energy available shall not exceed 20 J at a potential up! |+ J( F+ t/ n' _
to 2 V.: n8 N( p& W. v
NOTE If voltages higher than the limits specified in 8.4.2 c) are present, the LEAKAGE CURRENT limits referred6 W/ L4 [0 ]+ }7 o) I
to in 8.4.2 b) apply.
+ W4 L, ~2 i X, {5 K0 H- q# ~7 U E) \
Compliance is checked by inspection of the RISK MANAGEMENT FILE, by reference to the
: U# \5 c$ t8 o" E' ?- J* k& Xinstructions for use and by measurement.) y; e7 q/ r" ~/ m9 }
6 b2 `( z( Y5 b% J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。 |
|
/2 
|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
