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|  DSH 422 [- E3 n$ Q7 O' N# |
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| Temperature limit applied part W: e# T0 x8 l/ o
| 42, 42.3& W" k* C8 x, b2 r; n
| 60601-1(ed.2);am1;am2
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Standard(s)- (year and edition):2 @$ f3 t7 q( p G; F% R
IEC 60601-1:1988 Ed.2 Am1+Am2
7 z! Z% F/ c/ T, c( |! l8 `Sub clause(s): 42, 42.3, W3 ~6 p! u% P! @% s
Sheet n°: DSH-422( k+ ]1 [* J1 W! F. S0 a9 V
Subject: Temperature limit applied part% C: z7 F$ m* j1 t
Key words: Temperature limit, applied part, ambient.
" v& F& z, ~! T' L7 SConfirmed by CTL at its 39th meeting, in Cologne
. R( b- _4 A) y" c& Q1 M9 aQuestion:+ M# h0 L! H& O. R6 u) U; D: Z
It is not clear at what ambient temperature the limit of 41 °C should be applied. The% z7 A0 ]6 C2 V
temperature range of 10 °C to 40 °C stated in Sub-clause 10.2 applies to Table Xa and would. D) N" q% j" M. z/ ~' H
appear to apply in this instance. Is a 1 °C temperature difference correct or realistic?
% X# M+ C3 W- \" ]- b1 D2 Z8 G/ uDecision:9 K9 V' c4 T/ Y, p, i, P9 Z
When not otherwise specified by the manufacturer, the limit of 41 °C at an ambient
5 S& E: o* C6 V! B) ttemperature of 40 °C must be applied in NORMAL CONDITION or SINGLE FAULT
3 C2 a1 s' j- I. rCONDITION except were there is a medical justification for a higher limit/temperature rise.
7 U0 |2 ]# R$ g8 _) |This requirement should be addressed in Particular Standards.
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