DSH 425 Temperature limit applied part

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DSH 425 3 _& L0 v8 V9 }& i8 w6 y! H 0 S) Z- W7 _7 Z/ u/ Z" l

Temperature limit applied part

2.1.5

60601-1(ed.2);am1;am2 % S2 t4 S" ]% L

- V6 `4 T) i% U9 W7 }Standard(s)- (year and edition):
60601-1:1988 Ed.2 Am1+Am2
Sub clause(s): 2.1.5
Sheet n°: DSH-425
Subject: Temperature limit applied part
Key words: Applied part, temperature limit
7 M. W, N  x/ L% W) KConfirmed by CTL at its 39th meeting, in Cologne
+ N; U) p3 d7 \  l6 HQuestion:
& ~5 }. G7 {) d) Y. @. u( rThe EQUIPMENT worn by the patient, such as AMBULATORY ECG SYSTEM or
. C1 G) _" N5 t' W4 J9 \; _5 tAMBULATORY RECORDER is now considered as a APPLIED PART in addition to the
" u6 p. S. R7 i# i# X- Nassociated ELECTRODES and cables. Clause 42.3 does not allow surface temperature
exceeding 41 °C for an APPLIED PART and according to clause 3.1 EQUIPMENT shall cause
: r+ E. A7 a! f5 B" I& Nno safety hazard in NORMAL CONDITION and in SINGLE FAULT CONDITION. Very often
the EQUIPMENT exceeds the temperature limit of 41 °C under the above testing conditions.
Decision:
The instructions for use shall advise that the recorder is not to be worn in contact with the skin.
The ENCLOSURE is therefore not considered as an APPLIED PART and should comply
withTable Xa "Equipment parts which may in normal use have a brief contact with a patient
8 ]$ U$ _1 R) [* M; v50°C".

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