DSH 425 Temperature limit applied part

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DSH 425

Temperature limit applied part - h8 X" x/ {0 d4 J6 b; `- J

2.1.5

60601-1(ed.2);am1;am2 / O8 _  T7 o+ l% E, w+ {" S

Standard(s)- (year and edition):
60601-1:1988 Ed.2 Am1+Am2
Sub clause(s): 2.1.5
) q. s  l9 z: u: \Sheet n°: DSH-425
* ?9 D. E- i) r2 r4 q$ b- ASubject: Temperature limit applied part
Key words: Applied part, temperature limit
Confirmed by CTL at its 39th meeting, in Cologne
6 b/ l, T, u# `! l( X. N. MQuestion:
1 {* V2 W. T) W* f1 \; l7 nThe EQUIPMENT worn by the patient, such as AMBULATORY ECG SYSTEM or
% j6 t7 [3 }& h2 f1 D6 ^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
, x. {: B. y' |3 s. w+ _( f8 y1 Uno safety hazard in NORMAL CONDITION and in SINGLE FAULT CONDITION. Very often
: m$ O/ J) H; u$ W, v0 Nthe EQUIPMENT exceeds the temperature limit of 41 °C under the above testing conditions.
- q! }, c# H* s4 ?' i( @Decision:
The instructions for use shall advise that the recorder is not to be worn in contact with the skin.
- A$ |+ f" ^" w: g' ZThe 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
50°C".
$ d- Q2 |. V: j2 v/ m/ E