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|  DSH 411
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| General requirements
5 r$ J8 z( \! y+ t | 20.1
8 X' B, ~7 B% s4 L) n& x, U | 60601-1(ed.2);am1;am2' s6 }7 `1 n# t% C9 a" M$ s& F- [
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: G, y/ C0 B* e) x3 OStandard(s)- (year and edition):
& _$ e, n% X. IIEC 60601-1:1988 Ed.2 Am1+Am2
# B1 V$ b3 f! qSub clause(s): 20.1% c1 c) o6 @* \6 G; w" O! ]6 _- g- d
Sheet n°: DSH-411& `$ `2 n4 |) S2 S L) t( @3 }$ r
Subject: General requirements' p( q- V9 ~$ m3 S4 l8 }
Key words: Leakage current, SIP/SOP, working voltage, A-k7 g' A2 I8 ^3 k' {# J; }" }% `
Confirmed by CTL at its 39th meeting, in Cologne% U9 L# f/ v+ B* ]& b0 x% r
Question:
9 G/ D3 m; W4 h9 cI) Does exemption a) refer to voltages arising within the EQUIPMENT, to voltages appearing
" w$ A% A8 C' y3 h/ Y) p% S( ]9 [from external sources, or both?
4 ]) p: F0 s% |ii) Does exemption b) refer to the SFC of mains voltage on the SIP or SOP? Is insulation which2 s5 j6 b; n1 s0 |. Q
ensures absence of excessive LEAKAGE CURRENTS not to be tested?
: w# s+ o( O! l/ [. L& T" i2 Q; Giii) For exemption d) to apply, does the manufacturer have to restrict connection of the SIP and
8 A1 e6 c6 \3 U5 GSOP to other MEDICAL ELECTRICAL EQUIPMENT or can connection to non-medical
8 { b7 Z9 K: W" `" }equipment be permitted, subject to some restrictions?
* q6 r1 R; |/ u5 V* s, BDecision:9 R v" H4 A6 Q3 ~- P3 ^
i) a) applies only if the voltages within the SIP and SOP are less than SELV when connected to
, F% f$ v* J! Y! w6 n' k; IEQUIPMENT consistent with the instructions for use./ M* f8 q9 F2 z+ I$ f% U8 h
ii) b) applies to a SFC resulting from a single component failure within the SIP or SOP in
, A( d9 [8 r. y, E9 \: ]NORMAL USE i.e. connected as specified in the instructions for use. If such a SFC does not
/ Q9 x+ A9 J9 W2 r5 i; @% C, }produce excessive LEAKAGE CURRENTS then no additional insulation test is needed.7 E9 R" |& F, x* T% O% ~7 l
iii) d) applies only if the manufacturer restricts connection of the SIP or SOP to MEDICAL* K z9 r+ V; i0 z; s' e
ELECTRICAL EQUIPMENT6 s! t2 T3 ?/ S9 i3 [* V4 ^" B
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Q/ V- }( T& _& i |
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