DSH 412 Detection of fault

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DSH 412 ( b6 U& M+ r( N+ B: C& x+ m

Detection of fault 0 ?' G) |/ n7 ~1 V  x9 \, u

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60601-1(ed.2);am1;am2 8 Q% n& e6 H" Q& [9 K, u: U3 h

Standard(s)- (year and edition):
IEC 60601-1:1988 Ed.2 Am1+Am2
1 z9 J9 @7 f6 s3 N: ?" ^0 M- QSub clause(s):
Sheet n°: DSH-412
Subject: Detection of fault
" W' X: I. U, k4 G1 fKey words: SFC, detection, fault
/ p) K5 W: ?) OConfirmed by CTL at its 39th meeting, in Cologne
4 _6 c5 Z7 m, W$ pQuestion:
7 V# q4 x* F# V) G1 s* O1 j5 J: S* uShall a fault which remains undetected be considered a NORMAL CONDITION (NC) or a
SINGLE FAULT CONDITION (SFC)?
If every fault is considered as SFC, regardless of whether it is detected or not, the
consequence will be that there is no protection required against situations where an
( O: k& N9 e# I3 k5 w  L4 [' @5 i- rundetected first fault is followed by a second fault which may cause a SAFETY HAZARD.
& I; t, @) C2 r% D- ?! o2 NDecision:
If a fault is not detected (for example by periodic inspection, maintenance, auto test, etc....), it
' R; B" @# Q9 l& n5 u! {shall not be considered as a SINGLE FAULT CONDITION.
Time periodicity for the detection of fault depends on the risk analysis
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