3 q; q' @& H/ R$ u$ Z; R2 y+ mStandard(s)- (year and edition):. ?; ?# u+ s! u
IEC 60601-1:1988 Ed.2 Am1+Am2 ( Y4 j+ S2 O$ w1 A( y: ySub clause(s): 42, 42.33 K( X% s) y4 S# s0 P& y4 K
Sheet n°: DSH-422 I" g3 b4 w: |, O: ]& V
Subject: Temperature limit applied part . \' P9 ^, v) J/ bKey words: Temperature limit, applied part, ambient.* `5 ?+ W1 k2 c/ A* h' H. W Z
Confirmed by CTL at its 39th meeting, in Cologne 9 A% ~5 r! J9 P% ]4 R& O8 y" VQuestion:: m8 I/ I* A. S. c
It is not clear at what ambient temperature the limit of 41 °C should be applied. The $ }1 x0 M: t4 u1 i6 Jtemperature range of 10 °C to 40 °C stated in Sub-clause 10.2 applies to Table Xa and would& p: P- ^$ {7 r4 V$ ?5 [+ H1 n
appear to apply in this instance. Is a 1 °C temperature difference correct or realistic? 4 r' ~2 Y- ^! o% ?Decision:7 \, ~. v& K- W$ `# H. B% J) e
When not otherwise specified by the manufacturer, the limit of 41 °C at an ambient" h& z4 ?! x3 {1 V% T
temperature of 40 °C must be applied in NORMAL CONDITION or SINGLE FAULT ' x B: k" V# O% I* ?: v2 UCONDITION except were there is a medical justification for a higher limit/temperature rise. 3 s. j5 I0 T& `. Q9 pThis requirement should be addressed in Particular Standards.8 \: Y' `; s1 z( B& O* p4 s6 c5 B
. O! X) D% g: O8 L1 ?; e' `[attach]77085[/attach] 1 I: i( f: o" l7 n