DSH 422 Temperature limit applied part

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DSH 422 * E5 p6 S8 i& p, C$ T1 h7 c

Temperature limit applied part

42, 42.3

60601-1(ed.2);am1;am2 ( R+ e$ a0 n2 T1 h

Standard(s)- (year and edition):
$ @: i! i- v, _& o  Y* C5 oIEC 60601-1:1988 Ed.2 Am1+Am2
Sub clause(s): 42, 42.3
6 K) R' m% R2 g( c8 h( h; X2 DSheet n°: DSH-422
Subject: Temperature limit applied part
8 H) R. P- \! c5 V9 fKey words: Temperature limit, applied part, ambient.
/ u# N* l+ p7 p$ ^1 D1 ]2 s. V3 ^Confirmed by CTL at its 39th meeting, in Cologne
( n  P+ L" K+ K+ k/ w% }1 eQuestion:
7 r; f0 }) c3 `$ H  |  ~% `0 AIt is not clear at what ambient temperature the limit of 41 °C should be applied. The
2 x4 H6 D5 W2 C, A" Q. r1 w6 Ktemperature range of 10 °C to 40 °C stated in Sub-clause 10.2 applies to Table Xa and would
: \, K( e8 O+ Zappear to apply in this instance. Is a 1 °C temperature difference correct or realistic?
Decision:
When 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
( r4 |1 Q7 B4 qCONDITION except were there is a medical justification for a higher limit/temperature rise.
- K+ x+ x6 F4 M- B: \This requirement should be addressed in Particular Standards.


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