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|
|  DSH 425! A: ^1 n6 y! p9 i* J
$ e, b5 k( V7 `) X8 i
| Temperature limit applied part# D5 j5 G5 Q; Z5 D- f3 Y2 h) l$ w
| 2.1.5
+ k- o8 v5 j: v) _1 T5 C6 G' L | 60601-1(ed.2);am1;am2' j/ Z2 J4 A. [" C
|
$ d E; m4 A9 \# c& k- q1 AStandard(s)- (year and edition):4 k- t5 G; c; \ o
60601-1:1988 Ed.2 Am1+Am2" F! b8 y4 _$ k+ K& k0 `9 _! f9 ^
Sub clause(s): 2.1.5
! t8 \) F5 o; I' J( FSheet n°: DSH-425
: d3 I/ M7 }6 v6 Z% i5 M4 ]Subject: Temperature limit applied part! {1 o9 ^ h0 Z' h) Y# m
Key words: Applied part, temperature limit2 V9 Y2 l6 w8 a' _5 ?3 t
Confirmed by CTL at its 39th meeting, in Cologne
3 M3 E6 X- K1 ZQuestion:
9 {9 V1 |, I$ L5 ?! gThe EQUIPMENT worn by the patient, such as AMBULATORY ECG SYSTEM or
# o: q& m6 q+ X+ IAMBULATORY RECORDER is now considered as a APPLIED PART in addition to the- f' ?# ^, E5 J) ?5 R
associated ELECTRODES and cables. Clause 42.3 does not allow surface temperature( y5 B, N0 ^, R! \
exceeding 41 °C for an APPLIED PART and according to clause 3.1 EQUIPMENT shall cause j H I4 V9 d! s/ E( @" n
no safety hazard in NORMAL CONDITION and in SINGLE FAULT CONDITION. Very often3 ^2 Z4 P: l' ^ e( ~
the EQUIPMENT exceeds the temperature limit of 41 °C under the above testing conditions.
^* R& @/ ^' Q6 {! v& m. zDecision:
9 K. Y* N& `% u' N5 c* k8 F; bThe instructions for use shall advise that the recorder is not to be worn in contact with the skin.
. T+ P5 N t$ |The ENCLOSURE is therefore not considered as an APPLIED PART and should comply
0 A$ n& S1 I ]+ YwithTable Xa "Equipment parts which may in normal use have a brief contact with a patient
) Z' ^+ e# s& d7 ?50°C".- m" R! ?' [1 j3 x+ @$ L
2 S( f/ N8 Z) [8 I$ e4 B0 u
$ ]" _" \- j' a' F7 N. `6 `( G |
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发表于 2012-11-5 10:48
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