DSH 425 Temperature limit applied part

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DSH 425 2 y1 P8 ^+ Y+ f! U/ `8 x. R  _6 a & t$ c+ N, g' f! m% v

Temperature limit applied part 1 b- K. L7 [# g( H

2.1.5

60601-1(ed.2);am1;am2

0 N* j2 z- J2 mStandard(s)- (year and edition):
& z8 Q8 G% x4 H% m: V3 y! X60601-1:1988 Ed.2 Am1+Am2
* W: Y6 ]5 M5 }9 P* b" QSub clause(s): 2.1.5
Sheet n°: DSH-425
Subject: Temperature limit applied part
Key words: Applied part, temperature limit
Confirmed by CTL at its 39th meeting, in Cologne
. i' l+ O. J7 L1 ZQuestion:
8 N/ N7 l. @/ a' \1 A) ]The EQUIPMENT worn by the patient, such as AMBULATORY ECG SYSTEM or
AMBULATORY RECORDER is now considered as a APPLIED PART in addition to the
- \: I, `# ]6 Aassociated 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
) B* p# C& D! h1 o) A1 Kno 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.
9 M% H4 X" t2 p; X( v- ~Decision:
The instructions for use shall advise that the recorder is not to be worn in contact with the skin.
- g9 \1 f: O$ DThe 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
' G! F  h5 [3 C% j' _50°C".
9 |5 ^6 o* T- s) s8 a9 @# {; j, ?

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