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| DSH 422
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; c% @, E y+ m# ]* e) ~ | Temperature limit applied part9 k6 }$ V+ R6 d+ c. u+ M/ T/ ?
| 42, 42.3
2 y3 N/ _* K0 X; M$ b* V | 60601-1(ed.2);am1;am2
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: J1 K! E, p+ y }+ Q# R0 DStandard(s)- (year and edition):. X$ H7 u# E8 M. u5 d& J C6 H
IEC 60601-1:1988 Ed.2 Am1+Am2
5 a. s* H( x- Q7 o# MSub clause(s): 42, 42.34 k- b, _6 Z5 H- a$ f3 {
Sheet n°: DSH-422# H+ c1 w/ q* c) M
Subject: Temperature limit applied part
2 L& N+ L2 v1 [# iKey words: Temperature limit, applied part, ambient.
# M" m0 a7 C7 b' J, F% EConfirmed by CTL at its 39th meeting, in Cologne
5 B! ?1 C' y1 G3 A# e1 OQuestion:2 D3 R* T2 D% @6 p
It is not clear at what ambient temperature the limit of 41 °C should be applied. The
% i( n' {8 `7 h( x5 ]. ]7 V) |temperature range of 10 °C to 40 °C stated in Sub-clause 10.2 applies to Table Xa and would
; l( P4 a6 \& \, V) _& F; |+ `appear to apply in this instance. Is a 1 °C temperature difference correct or realistic?# {$ u' K' g) F; m
Decision:
( J2 ]" Y7 \& K( r6 mWhen not otherwise specified by the manufacturer, the limit of 41 °C at an ambient
! m5 `: U" u; y2 J6 d8 G8 U& Btemperature of 40 °C must be applied in NORMAL CONDITION or SINGLE FAULT* l& s6 |! N" G
CONDITION except were there is a medical justification for a higher limit/temperature rise.- M/ D) x2 v- a. L" ?$ g
This requirement should be addressed in Particular Standards.3 \) q! O/ Q6 x$ V! H
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