DSH 425 Temperature limit applied part

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DSH 425 % W. O4 J- w& p2 u. N* S

Temperature limit applied part 9 D6 H6 }' E& M$ Q

2.1.5 5 T( Q  t& Z; G& x# B& u0 V) ?2 p8 _2 R

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

Standard(s)- (year and edition):
0 [1 O& P: w4 f- J60601-1:1988 Ed.2 Am1+Am2
1 T3 I. H, }  l( S, O3 gSub clause(s): 2.1.5
Sheet n°: DSH-425
/ y9 x5 ^% C! k$ ~7 O) b, u5 vSubject: Temperature limit applied part
Key words: Applied part, temperature limit
Confirmed by CTL at its 39th meeting, in Cologne
  V- q2 O9 b$ E. VQuestion:
The EQUIPMENT worn by the patient, such as AMBULATORY ECG SYSTEM or
% o8 ~- ]- k0 y# r0 gAMBULATORY RECORDER is now considered as a APPLIED PART in addition to the
$ Q/ X, I1 J# M% b2 [3 i! R/ Z& Fassociated ELECTRODES and cables. Clause 42.3 does not allow surface temperature
: P( N: S. v* q& W$ N% m5 \exceeding 41 °C for an APPLIED PART and according to clause 3.1 EQUIPMENT shall cause
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.
0 k$ N4 N& ^, w, i- ?Decision:
The instructions for use shall advise that the recorder is not to be worn in contact with the skin.
" S. g+ i6 x( f: rThe ENCLOSURE is therefore not considered as an APPLIED PART and should comply
- @/ h/ W9 ]4 `$ K; h8 r* WwithTable Xa "Equipment parts which may in normal use have a brief contact with a patient
50°C".


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