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Standard(s)- (year and edition):
! b, H9 j g. [/ D60601-1:1988 Ed.2 Am1+Am2
+ S4 g2 v$ Q4 l5 s! }" }$ V7 ]4 H! lSub clause(s): 2.1.5' i A) v$ K/ H7 Q
Sheet n°: DSH-425
* y6 n) a T' Z& hSubject: Temperature limit applied part
- P1 X2 Q" j9 O$ @Key words: Applied part, temperature limit
# R+ v/ [* J1 W) C& I% [" C; IConfirmed by CTL at its 39th meeting, in Cologne4 ^2 R. k8 i/ _4 r% u
Question:
8 y+ z& I$ i, o( L6 h* e# wThe EQUIPMENT worn by the patient, such as AMBULATORY ECG SYSTEM or
9 k) D8 T. v8 C% C! _' z3 ?AMBULATORY RECORDER is now considered as a APPLIED PART in addition to the( r! M+ T$ L% K) P5 [4 F0 C
associated ELECTRODES and cables. Clause 42.3 does not allow surface temperature
$ C3 C$ [. o: L; D e' o+ t0 G6 q5 oexceeding 41 °C for an APPLIED PART and according to clause 3.1 EQUIPMENT shall cause* D$ R) L- C: m4 a* I7 {
no safety hazard in NORMAL CONDITION and in SINGLE FAULT CONDITION. Very often
5 d: ?0 b# E, z+ e4 A. Pthe EQUIPMENT exceeds the temperature limit of 41 °C under the above testing conditions.; ~- z- n3 e$ X7 ^
Decision:# R! s6 L, [3 u0 s
The instructions for use shall advise that the recorder is not to be worn in contact with the skin.
$ M7 q: H7 {) D: E, I' _The ENCLOSURE is therefore not considered as an APPLIED PART and should comply
7 r4 i+ d1 p/ s, c0 a8 R4 C7 u$ N8 PwithTable Xa "Equipment parts which may in normal use have a brief contact with a patient7 H: v! q0 y1 M% ^+ N! c/ S* d1 }# f
50°C".
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发表于 2012-11-5 10:48
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