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|  DSH 422 l. G h" |1 o& g, w- R
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| Temperature limit applied part
4 ?& _, Y4 x/ A j | 42, 42.3
. ~2 H. B4 A" N8 s6 \ | 60601-1(ed.2);am1;am2
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3 ]2 x$ f* n; W6 AStandard(s)- (year and edition):0 q) K1 }; d* x9 a# s4 }9 P
IEC 60601-1:1988 Ed.2 Am1+Am2: D7 I! N& I) F- q x
Sub clause(s): 42, 42.3& D9 ]# r: o- W: Q$ b7 C# O
Sheet n°: DSH-4220 f, Z( Y3 d4 p- V) N0 D% m
Subject: Temperature limit applied part, B E, `$ L9 Y4 h- D
Key words: Temperature limit, applied part, ambient.
( _7 B& R4 @, o8 vConfirmed by CTL at its 39th meeting, in Cologne& t$ d; H+ D) w; ^
Question:
3 ^$ s0 u8 o6 o/ TIt is not clear at what ambient temperature the limit of 41 °C should be applied. The3 t) G7 H# V2 }9 j' n4 |8 z
temperature range of 10 °C to 40 °C stated in Sub-clause 10.2 applies to Table Xa and would
@- d: J4 e3 K5 @+ G8 Oappear to apply in this instance. Is a 1 °C temperature difference correct or realistic?
- Z) n5 j+ w3 R& J3 e pDecision:
- l. n0 `7 z" w$ d. e+ p4 S0 EWhen not otherwise specified by the manufacturer, the limit of 41 °C at an ambient& j3 s. U& |/ W+ V$ }: p
temperature of 40 °C must be applied in NORMAL CONDITION or SINGLE FAULT c# e/ K# T+ U y3 i4 M
CONDITION except were there is a medical justification for a higher limit/temperature rise.
. Q; W: ` A* a1 E0 ]This requirement should be addressed in Particular Standards. e3 G; J8 R3 k$ ]
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