DSH 422 Temperature limit applied part

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DSH 422 & f4 i# @$ m5 l" [4 [3 C/ g % V* J5 p% D; W4 c

Temperature limit applied part ' X$ |  P+ w$ c4 N" \: M' |

42, 42.3   e0 ?$ G5 q) u; o9 f6 s3 t; ?# r

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

Standard(s)- (year and edition):
2 p: `8 U" E9 ^7 WIEC 60601-1:1988 Ed.2 Am1+Am2
Sub clause(s): 42, 42.3
Sheet n°: DSH-422
: ~8 i1 B) R9 O+ N2 FSubject: Temperature limit applied part
Key words: Temperature limit, applied part, ambient.
Confirmed by CTL at its 39th meeting, in Cologne
Question:
+ D; H/ y7 K, i/ E7 `" z- Y' ^It 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
appear to apply in this instance. Is a 1 °C temperature difference correct or realistic?
$ Y0 H% I/ ?! r" t( m4 vDecision:
When not otherwise specified by the manufacturer, the limit of 41 °C at an ambient
- Q; T9 E% i+ G: B1 _temperature 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.
) \2 \" W  k6 u5 gThis requirement should be addressed in Particular Standards.

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