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标题: DSH 422 Temperature limit applied part [打印本页]

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作者: 小米    时间: 2012-11-5 11:00
标题: DSH 422 Temperature limit applied part

DSH 422 ' o3 h- _: |$ u& {

Temperature limit applied part 9 z4 [* k! N2 [5 q

42, 42.3 + D9 y8 G# _) \7 e8 E

60601-1(ed.2);am1;am2 & c0 X) P6 \  C6 p, C/ U

Standard(s)- (year and edition):
IEC 60601-1:1988 Ed.2 Am1+Am2
Sub clause(s): 42, 42.3
Sheet n°: DSH-422
9 O- F& H3 J0 Q' j( t4 ?( y- d: `Subject: Temperature limit applied part
Key words: Temperature limit, applied part, ambient.
$ `" J% ^- y: T8 B* B* jConfirmed 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
8 L# n! a' y$ [) j5 Ttemperature range of 10 °C to 40 °C stated in Sub-clause 10.2 applies to Table Xa and would
# |" i' n4 G+ ^( e2 d' J9 iappear to apply in this instance. Is a 1 °C temperature difference correct or realistic?
Decision:
( x  b$ N* I% [; C! l9 r/ ]When not otherwise specified by the manufacturer, the limit of 41 °C at an ambient
! k) M* A* o% H& S: J( htemperature 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.
9 o, D* i5 W( J5 a4 R3 b: qThis requirement should be addressed in Particular Standards.

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