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|  DSH 425
4 j$ M7 j; E3 {: ?* t. o8 w* B w7 h
| Temperature limit applied part
- h2 E( _& n# R# G6 D% H+ C6 _ | 2.1.56 T3 Y2 R D4 r, ]% S- l
| 60601-1(ed.2);am1;am27 X9 E. @2 V) C- K+ X. ~# g
|
7 N/ t: w3 T- K( U4 ]Standard(s)- (year and edition):
+ g0 n% H! r: |/ _9 u1 N6 n( k60601-1:1988 Ed.2 Am1+Am2
7 c! C. M$ k; \2 uSub clause(s): 2.1.5
8 s1 x5 y- T) |3 R$ R6 jSheet n°: DSH-425( a9 |) ~: T+ k
Subject: Temperature limit applied part" V( A0 ~; F: d) M- ^& \: `) u
Key words: Applied part, temperature limit2 p9 t& V$ V+ B: M% F+ p
Confirmed by CTL at its 39th meeting, in Cologne
P, c j- H; S# B4 z, }* y9 v4 ?) gQuestion:% s) ~1 M5 g& P$ Y y* K
The EQUIPMENT worn by the patient, such as AMBULATORY ECG SYSTEM or
) i0 y/ }! E, R1 [: QAMBULATORY RECORDER is now considered as a APPLIED PART in addition to the
, f3 Z2 S( e4 W9 R2 Q. b4 v: yassociated ELECTRODES and cables. Clause 42.3 does not allow surface temperature' x7 |, t' ^# z) ]- a6 D. `- K
exceeding 41 °C for an APPLIED PART and according to clause 3.1 EQUIPMENT shall cause
+ v" b j3 C! O+ rno safety hazard in NORMAL CONDITION and in SINGLE FAULT CONDITION. Very often
! X: V: ^* h) ]the EQUIPMENT exceeds the temperature limit of 41 °C under the above testing conditions.
/ ?# G1 t( e |; [" vDecision:
) K% P& N4 s h2 PThe instructions for use shall advise that the recorder is not to be worn in contact with the skin.
s8 I5 H# D8 `6 x6 a) ?The ENCLOSURE is therefore not considered as an APPLIED PART and should comply
i, Y3 P- k! |' M5 Z* ZwithTable Xa "Equipment parts which may in normal use have a brief contact with a patient9 S q% M2 K" ?/ `- f" p' z
50°C".
4 J- t6 C+ q( N3 Z1 `( e9 N$ J. r0 z) [, e. l+ P! C
/ D5 i y) ^1 m- ~( W, W |
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发表于 2012-11-5 10:48
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