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  • Sheet-399 17a 17g

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    This document is Decision Sheet DSH-399 regarding IEC 60601-1 sub clauses 17 a) and 17 g). It addresses whether the impedance of a component certified to high integrity standards is sufficient without reviewing air clearance and creepage distance. The decision is that secondary circuits providing protection after a short-circuit must still be investigated, and component failures in these circuits investigated as a single fault condition. Explanatory notes state sub-clause 52.5.9 requires investigating component failures providing protection, except for certain capacitors, as a short-circuit is a normal condition rather than single fault.

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    This document is Decision Sheet DSH-399 regarding IEC 60601-1 sub clauses 17 a) and 17 g). It addresses whether the impedance of a component certified to high integrity standards is sufficient without reviewing air clearance and creepage distance. The decision is that secondary circuits providing protection after a short-circuit must still be investigated, and component failures in these circuits investigated as a single fault condition. Explanatory notes state sub-clause 52.5.9 requires investigating component failures providing protection, except for certain capacitors, as a short-circuit is a normal condition rather than single fault.

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    8 views1 page

    Sheet-399 17a 17g

    Uploaded by

    fearstrange
    This document is Decision Sheet DSH-399 regarding IEC 60601-1 sub clauses 17 a) and 17 g). It addresses whether the impedance of a component certified to high integrity standards is sufficient without reviewing air clearance and creepage distance. The decision is that secondary circuits providing protection after a short-circuit must still be investigated, and component failures in these circuits investigated as a single fault condition. Explanatory notes state sub-clause 52.5.9 requires investigating component failures providing protection, except for certain capacitors, as a short-circuit is a normal condition rather than single fault.

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    DECISION SHEET

    Standard(s)- (year and edition): Sub clause(s): Sheet n°:


    IEC 60601-1:1988 Ed.2 17 a) and 17 g) DSH-399
    Am1+Am2

    Subject: Key words: Confirmed by CTL at its 39th


    Component impedance Component impedance, high meeting, in Cologne
    integrity

    Question:

    Component impedance is generally unreliable. Components certified to IEC 60384-14 etc. can
    be considered of high integrity. Is the impedance of a component sufficient? Does investigation
    of the product require further review of AIR CLEARANCE and CREEPAGE DISTANCE for such
    a component? Does this sub-clause mean that further component review is not required?

    Decision:

    Secondary circuits providing protective means after short-circuiting of inadequate AIR


    CLEARANCE and CREEPAGE DISTANCE must be investigated. Failure of components in
    these circuits shall be investigated as a SINGLE FAULT CONDITION

    Explanatory notes:

    Sub-clause 52.5.9 requires that failure of components shall be investigated and especially those
    components which provide protective means. Exempted are capacitors (X1 and X2) complying
    with IEC 60384-14 connected between parts of opposite polarity of the supply mains. The short-
    circuit of inadequate AIR CLEARANCE and CREEPAGE DISTANCE is a NORMAL
    CONDITION.

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