DSH 422 Temperature limit applied part
http://decisions.iecee.org/icons/ecblank.gif DSH 422
Temperature limit applied part
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
Sheet n°: DSH-422
Subject: Temperature limit applied part
Key words: Temperature limit, applied part, ambient.
Confirmed by CTL at its 39th meeting, in Cologne
Question:
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?
Decision:
When not otherwise specified by the manufacturer, the limit of 41 °C at an ambient
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.
This requirement should be addressed in Particular Standards.
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