DSH 422 Temperature limit applied part

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DSH 422 6 [' Q. s9 q* J+ W2 q% s. N & \5 a$ J; m! |/ ]

Temperature limit applied part , X! |( d8 q! \. j7 v

42, 42.3

60601-1(ed.2);am1;am2 ; M& q6 e( p. L0 m5 _# q; S

Standard(s)- (year and edition):
IEC 60601-1:1988 Ed.2 Am1+Am2
1 o9 m' e# m+ l5 L4 |Sub clause(s): 42, 42.3
# `, {3 L1 h' O& e' w: WSheet n°: DSH-422
7 @, s% r, L; y/ \' A* [0 i* YSubject: Temperature limit applied part
* {& C1 c; H1 I3 K! c7 @9 W* NKey words: Temperature limit, applied part, ambient.
# {0 T; e1 J- @6 Y. U+ u) qConfirmed by CTL at its 39th meeting, in Cologne
Question:
+ J9 R  V+ N# P9 Z3 @' v' v3 zIt is not clear at what ambient temperature the limit of 41 °C should be applied. The
4 o2 ~  X% _0 ttemperature 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?
Decision:
0 a. Q* G6 n2 q1 BWhen not otherwise specified by the manufacturer, the limit of 41 °C at an ambient
2 v. a- X9 S3 vtemperature of 40 °C must be applied in NORMAL CONDITION or SINGLE FAULT
7 `) U4 r( ], z4 d% S. OCONDITION except were there is a medical justification for a higher limit/temperature rise.
) }6 V* }2 G: v4 q; UThis requirement should be addressed in Particular Standards.
- ?8 U- `3 `* ?) ~; K
7 a2 {; z# T# J6 j