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|  DSH 422) Q# c: L0 B$ |. V1 V' |
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| Temperature limit applied part
; E9 w5 t; c8 g- s: m | 42, 42.3 F, @/ _, D5 ~1 p$ y- P* w
| 60601-1(ed.2);am1;am2) c2 ?. ?3 j5 R5 W. J! U5 z
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Standard(s)- (year and edition):
- {, _ n! O$ U! ]7 X4 X4 ^4 X& ^IEC 60601-1:1988 Ed.2 Am1+Am2
& \, C$ x: K4 Z2 ZSub clause(s): 42, 42.3
8 K+ t3 K i4 q- V0 ^: r! ESheet n°: DSH-422* H, |5 ?4 q6 `% H: p2 b
Subject: Temperature limit applied part/ F6 i3 Q5 p+ i
Key words: Temperature limit, applied part, ambient.
( j5 k0 p- ~; C: R! `# rConfirmed by CTL at its 39th meeting, in Cologne. Z1 `& z2 D- e" s
Question:
% c4 H9 _+ t9 t* J1 SIt is not clear at what ambient temperature the limit of 41 °C should be applied. The
! U# O- U# _" dtemperature range of 10 °C to 40 °C stated in Sub-clause 10.2 applies to Table Xa and would, T/ F# T2 F5 C( z& a
appear to apply in this instance. Is a 1 °C temperature difference correct or realistic?
3 d" r+ M0 y' J5 t! x# L6 O d* ]Decision:! o6 |) ~# j2 E# ?
When not otherwise specified by the manufacturer, the limit of 41 °C at an ambient
0 h3 d: X4 `+ Ctemperature of 40 °C must be applied in NORMAL CONDITION or SINGLE FAULT
& {/ k2 s5 l" E6 FCONDITION except were there is a medical justification for a higher limit/temperature rise.
: W; }) @( t2 h' ]+ T: [" V: {This requirement should be addressed in Particular Standards.# {0 h6 b: Q/ v+ o9 d
C1 p" m! C9 y# u4 `
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发表于 2012-11-5 11:00
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