DSH 425 Temperature limit applied part

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DSH 425 9 p; ~- q' d" d0 k/ L+ T 8 E' {! e. N) d# V

Temperature limit applied part / Q+ e; }& _9 o

2.1.5 & @) F6 B9 F3 s: O" N4 B4 b  C

60601-1(ed.2);am1;am2 ; \* T3 M1 @$ E9 Q) g

1 N- G6 R. d/ \2 Q2 sStandard(s)- (year and edition):
9 I# n  y# D, p6 c' P1 ]3 X" d: |60601-1:1988 Ed.2 Am1+Am2
Sub clause(s): 2.1.5
: }0 z  }5 y9 S3 |" sSheet n°: DSH-425
+ t+ _5 q0 Y$ T5 u! I: y1 ^Subject: Temperature limit applied part
Key words: Applied part, temperature limit
5 v. l+ i* i5 |8 D( }* u$ }! F2 ^9 RConfirmed by CTL at its 39th meeting, in Cologne
Question:
! o, W, ]; P$ N/ d9 f+ ~* s7 J$ iThe 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
+ B1 M  n  r8 M+ ?0 Iexceeding 41 °C for an APPLIED PART and according to clause 3.1 EQUIPMENT shall cause
* q% }- C$ o( v6 E; B5 [- uno safety hazard in NORMAL CONDITION and in SINGLE FAULT CONDITION. Very often
& }6 g3 Z, E/ p8 fthe EQUIPMENT exceeds the temperature limit of 41 °C under the above testing conditions.
Decision:
0 Y# Y2 \! D" e- SThe 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
7 v+ V( D; `" pwithTable Xa "Equipment parts which may in normal use have a brief contact with a patient
50°C".