DSH 422 Temperature limit applied part

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DSH 422 / F' x1 A2 f% P3 R9 G: X* \# d . e6 u6 h) M, R' @( F

Temperature limit applied part / g8 e8 q" x) C5 }$ s0 y+ O# I

42, 42.3

60601-1(ed.2);am1;am2 6 `1 d, L" g/ o- P9 r5 M/ Q

Standard(s)- (year and edition):
' I0 V1 q9 q3 X+ u) oIEC 60601-1:1988 Ed.2 Am1+Am2
: k5 C4 y" I2 j0 `6 L: V7 CSub clause(s): 42, 42.3
Sheet n°: DSH-422
7 z& Q+ M5 C2 K) X  |2 |+ cSubject: Temperature limit applied part
Key words: Temperature limit, applied part, ambient.
7 I+ Z# X0 v" _6 x  V5 V' V7 M8 i  \( vConfirmed by CTL at its 39th meeting, in Cologne
8 N5 v1 T& Z; E6 b! ^1 [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?
# |3 `5 d7 h; c/ ?- sDecision:
- t2 k1 }7 P" WWhen 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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