DSH 422 Temperature limit applied part

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DSH 422 ' M, Y7 f1 y4 |2 y, J

Temperature limit applied part ) e, U) e! V+ T! J# Q2 [5 P

42, 42.3

60601-1(ed.2);am1;am2

Standard(s)- (year and edition):
IEC 60601-1:1988 Ed.2 Am1+Am2
Sub clause(s): 42, 42.3
& G, v; C5 d  u( ^2 c3 @Sheet n°: DSH-422
- P9 T/ O- a0 i9 @: C9 p0 ESubject: Temperature limit applied part
5 L7 l/ ]9 q3 B8 |, k, V) Z9 ~Key words: Temperature limit, applied part, ambient.
+ o; I/ @) `2 C# ?8 qConfirmed by CTL at its 39th meeting, in Cologne
Question:
3 x& G7 T" @( d4 EIt is not clear at what ambient temperature the limit of 41 °C should be applied. The
temperature range of 10 °C to 40 °C stated in Sub-clause 10.2 applies to Table Xa and would
9 Y) S  I* y/ T$ g7 ]2 M7 t: _appear to apply in this instance. Is a 1 °C temperature difference correct or realistic?
Decision:
9 w2 A: k+ [1 o  K9 o6 j) u8 C" WWhen not otherwise specified by the manufacturer, the limit of 41 °C at an ambient
1 u5 W, k0 O( ]8 K- j6 htemperature of 40 °C must be applied in NORMAL CONDITION or SINGLE FAULT
) U8 |, P% c$ |2 Q: kCONDITION except were there is a medical justification for a higher limit/temperature rise.
+ Y) a# d% _7 j- nThis requirement should be addressed in Particular Standards.