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|  DSH 425- Y- ]: S8 {" ^$ L; ~. e+ W
; f) R. F" Q$ }/ ^. }6 |. S | Temperature limit applied part
! m4 v: j3 L" B7 d6 [6 E) ^ | 2.1.5: {4 N2 |) J0 {" J5 f9 O8 I5 |7 {) V
| 60601-1(ed.2);am1;am2
p3 x9 ~8 b: U |
: g6 G. |& [( a0 ]3 CStandard(s)- (year and edition):
. K: y* l8 ]# z8 h5 d60601-1:1988 Ed.2 Am1+Am2
, g9 }5 v8 \1 ]3 {/ c" YSub clause(s): 2.1.5. M V1 }4 x4 R) e
Sheet n°: DSH-425
* ? N: P/ s9 a; h8 dSubject: Temperature limit applied part4 W8 K' L7 }8 |! L8 f; c
Key words: Applied part, temperature limit2 m& v- l% g7 C, `0 w
Confirmed by CTL at its 39th meeting, in Cologne
' @7 L" H- Q; \- ~Question:7 W* P: m5 Y0 U
The EQUIPMENT worn by the patient, such as AMBULATORY ECG SYSTEM or
; D5 j1 i! B( S9 ]AMBULATORY RECORDER is now considered as a APPLIED PART in addition to the
1 w. v" ]- L! f/ O& _ _- [associated ELECTRODES and cables. Clause 42.3 does not allow surface temperature& E% t' q3 Y/ Y/ h
exceeding 41 °C for an APPLIED PART and according to clause 3.1 EQUIPMENT shall cause. ~% o. H; P. k% f. m' o
no safety hazard in NORMAL CONDITION and in SINGLE FAULT CONDITION. Very often3 x6 k8 [: ]& v0 ^- t3 T
the EQUIPMENT exceeds the temperature limit of 41 °C under the above testing conditions.
5 l' ]! V: g* }- JDecision:
0 K+ X2 \6 V! w. oThe instructions for use shall advise that the recorder is not to be worn in contact with the skin.+ W$ t2 P! m( u. [* k. F, @
The ENCLOSURE is therefore not considered as an APPLIED PART and should comply
8 P' r& v- T8 awithTable Xa "Equipment parts which may in normal use have a brief contact with a patient
$ n' k. v, M* |' U2 r50°C".
( U& X4 x: H: F0 y" H: B$ Y) }! F: b2 x3 p8 D6 S( p/ h
9 o& ]! M4 Y- t' C9 ~
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发表于 2012-11-5 10:48
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