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| DSH 412
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( t+ j# u& E7 k9 { | Detection of fault- l" {& {$ X: Y# ]
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, }! A9 G9 S( O | 60601-1(ed.2);am1;am29 R$ E7 D* D! v6 q
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" j: t6 ]7 e$ ^: L" y- F2 I2 dStandard(s)- (year and edition):
4 I |/ K! V% ^8 X5 \+ ^IEC 60601-1:1988 Ed.2 Am1+Am2
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Sheet n°: DSH-412
5 w5 Q4 z5 C1 u+ K1 D. FSubject: Detection of fault1 J. p; {# B* t0 x* R/ i
Key words: SFC, detection, fault1 U# L9 |4 V% I |; I
Confirmed by CTL at its 39th meeting, in Cologne+ ]1 V* s- O2 L" e
Question:
( u8 s: ^5 k, G* O; L0 P" m5 u6 SShall a fault which remains undetected be considered a NORMAL CONDITION (NC) or a3 Y- g' T, f8 X2 o
SINGLE FAULT CONDITION (SFC)?7 s, \- n# Q; D' ?
If every fault is considered as SFC, regardless of whether it is detected or not, the
, k& ]" }7 B$ s+ S) P, J/ r7 [6 Econsequence will be that there is no protection required against situations where an$ l; G2 u X6 p! ^# ^5 q# O$ ?5 d
undetected first fault is followed by a second fault which may cause a SAFETY HAZARD.
( N+ \9 }9 n$ v. T- N4 V8 g2 Y* pDecision:
7 }3 F) { U- A. S2 x4 ~% ]If a fault is not detected (for example by periodic inspection, maintenance, auto test, etc....), it1 L$ I- v. b" X1 K, H
shall not be considered as a SINGLE FAULT CONDITION.% N) Y+ g: Y- X& @) ~ p! I& S, P
Time periodicity for the detection of fault depends on the risk analysis7 `# R& L0 f- C; h7 n
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