DSH 425 Temperature limit applied part

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DSH 425 ( g) S4 [- x: c4 P# M$ ~/ A / J, b/ Y* u7 [) ?8 x% e

Temperature limit applied part

2.1.5

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

: B/ B1 W4 t) yStandard(s)- (year and edition):
6 m  O, v/ Q3 R; }60601-1:1988 Ed.2 Am1+Am2
* A$ C) z" k- k0 R& LSub clause(s): 2.1.5
Sheet n°: DSH-425
Subject: Temperature limit applied part
/ O2 `/ b  b; _7 i" z9 e; eKey words: Applied part, temperature limit
Confirmed by CTL at its 39th meeting, in Cologne
Question:
* ~$ w1 A" H, }9 e" B: ^2 ~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
associated 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
6 \7 G" T& o6 v+ ]- j1 }no 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.
3 Y, x/ a) l" w2 ?Decision:
5 l: v9 K9 c' B& {) _& }The instructions for use shall advise that the recorder is not to be worn in contact with the skin.
, ~- z5 M9 k- W% G( tThe ENCLOSURE is therefore not considered as an APPLIED PART and should comply
3 i! S- i- S1 k# X, |4 @# X( fwithTable Xa "Equipment parts which may in normal use have a brief contact with a patient
50°C".
! [$ o0 b9 r5 Q+ U; O3 ~# C

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