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|  DSH 4229 `. P3 N E: M3 y
* W* b8 ]2 N: ` | Temperature limit applied part
0 x Z, K5 z9 w | 42, 42.3
8 h" \5 E+ { u# y& |+ E | 60601-1(ed.2);am1;am2( K) o# W9 S- u! o% W% X3 O& V
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$ w8 t! t6 t: B2 A) R4 n# g" P# wStandard(s)- (year and edition):
$ R; ~" u* h ]4 @# g3 oIEC 60601-1:1988 Ed.2 Am1+Am2
$ t# y" W" Z- ~. s$ s- ?8 }+ VSub clause(s): 42, 42.3
1 `" {. A+ _- u* G' E+ I' R6 ~Sheet n°: DSH-422! R' ^1 G5 |) I/ w9 P
Subject: Temperature limit applied part2 N1 b. I h8 W! e( |4 G
Key words: Temperature limit, applied part, ambient.3 m3 M% N4 X" g0 R
Confirmed by CTL at its 39th meeting, in Cologne
3 P A5 T4 [& r" K7 nQuestion:
# v/ l/ H6 V3 o, yIt is not clear at what ambient temperature the limit of 41 °C should be applied. The
; f/ E0 s4 N9 y! Utemperature range of 10 °C to 40 °C stated in Sub-clause 10.2 applies to Table Xa and would( q6 e6 Q& u, q) L e
appear to apply in this instance. Is a 1 °C temperature difference correct or realistic?% {6 U3 |! k5 h
Decision:
2 b' e3 t" C: ^2 \7 \When not otherwise specified by the manufacturer, the limit of 41 °C at an ambient
9 W6 T/ d; w; S% m1 ]5 a$ c2 Xtemperature of 40 °C must be applied in NORMAL CONDITION or SINGLE FAULT1 p6 F; R6 L; Z1 L
CONDITION except were there is a medical justification for a higher limit/temperature rise.
- U7 f" m5 L, k6 p* ?This requirement should be addressed in Particular Standards.
& W! l% q1 [' s" R' u1 L8 \. o, \ r, D" z
1 x7 t2 i, c0 ?) \9 l
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