DSH 422 Temperature limit applied part

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Temperature limit applied part

42, 42.3 ) W4 P6 c" @- _6 B" Y6 N

60601-1(ed.2);am1;am2 2 j0 N$ \/ L3 A

9 y  \, D" U% S1 B( rStandard(s)- (year and edition):
; M4 A7 ~, z7 q& {+ B' k) e) k' |# YIEC 60601-1:1988 Ed.2 Am1+Am2
Sub clause(s): 42, 42.3
Sheet n°: DSH-422
Subject: Temperature limit applied part
Key words: Temperature limit, applied part, ambient.
# c1 H' S/ s1 j3 a0 a& JConfirmed by CTL at its 39th meeting, in Cologne
$ T$ N) x, q& C8 {! TQuestion:
0 D) g/ ]8 U' W$ X1 i* B5 gIt is not clear at what ambient temperature the limit of 41 °C should be applied. The
) Q4 b' p4 f7 j2 L( k: j8 A- O. otemperature range of 10 °C to 40 °C stated in Sub-clause 10.2 applies to Table Xa and would
appear to apply in this instance. Is a 1 °C temperature difference correct or realistic?
# W$ T6 a9 I( c1 }5 o/ A; bDecision:
, x9 ]+ x/ @5 ~When not otherwise specified by the manufacturer, the limit of 41 °C at an ambient
7 i; u0 h" u" H' P+ Atemperature of 40 °C must be applied in NORMAL CONDITION or SINGLE FAULT
CONDITION except were there is a medical justification for a higher limit/temperature rise.
This requirement should be addressed in Particular Standards.
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