DSH 422 Temperature limit applied part

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DSH 422

Temperature limit applied part

42, 42.3

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

8 O# Q* c/ F) S: i2 y% aStandard(s)- (year and edition):
2 G: W7 J% `# I0 i5 CIEC 60601-1:1988 Ed.2 Am1+Am2
Sub clause(s): 42, 42.3
+ Z1 I( J* {5 i+ N6 k8 a! R) T. tSheet n°: DSH-422
Subject: Temperature limit applied part
Key words: Temperature limit, applied part, ambient.
; E5 f+ U! ?! EConfirmed by CTL at its 39th meeting, in Cologne
Question:
1 K4 h+ @: C5 Z7 x7 K( d5 R/ WIt 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
) E3 e& b* z5 a0 t: K5 wappear to apply in this instance. Is a 1 °C temperature difference correct or realistic?
) u3 Z) b$ \: k* g+ f6 y0 xDecision:
% a1 Y6 |( B6 B2 }* Z6 PWhen 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.
& s$ n# a* \. g) A) I6 MThis requirement should be addressed in Particular Standards.

) H5 k( G, j6 Z) R( e