DSH 411 General requirements

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DSH 411 9 C1 _% w$ T; |9 a 0 Z/ a5 V+ C7 l4 d2 {" r

General requirements

20.1 ( e' K, Q& h; _" o: w' r8 j3 M

60601-1(ed.2);am1;am2 ) R6 y0 N- B9 k& m; @. c5 R. X

) z" U2 r2 ?+ W# a+ IStandard(s)- (year and edition):
6 q: D  S# X# n$ z+ e- V) S* XIEC 60601-1:1988 Ed.2 Am1+Am2
+ e0 Y7 v" E9 ]& `' N. JSub clause(s): 20.1
Sheet n°: DSH-411
& d- `2 ^$ j' [! {5 hSubject: General requirements
Key words: Leakage current, SIP/SOP, working voltage, A-k
5 l/ c- J; {9 S8 r1 ]7 GConfirmed by CTL at its 39th meeting, in Cologne
Question:
2 s8 x/ i0 q3 r5 f& yI) Does exemption a) refer to voltages arising within the EQUIPMENT, to voltages appearing
: |0 a: I' u5 cfrom external sources, or both?
# A5 |9 T3 H9 Rii) Does exemption b) refer to the SFC of mains voltage on the SIP or SOP? Is insulation which
ensures absence of excessive LEAKAGE CURRENTS not to be tested?
1 b' e. ^8 t' w, |0 giii) For exemption d) to apply, does the manufacturer have to restrict connection of the SIP and
- n) `7 K$ P9 m; ]  H! b: d" C( [' J. `SOP to other MEDICAL ELECTRICAL EQUIPMENT or can connection to non-medical
equipment be permitted, subject to some restrictions?
7 O( v* ?; x; e5 J% T; x6 v5 VDecision:
i) a) applies only if the voltages within the SIP and SOP are less than SELV when connected to
) y1 J7 n8 H0 R/ C" XEQUIPMENT consistent with the instructions for use.
ii) b) applies to a SFC resulting from a single component failure within the SIP or SOP in
) n5 {! V2 X" p2 _NORMAL USE i.e. connected as specified in the instructions for use. If such a SFC does not
produce excessive LEAKAGE CURRENTS then no additional insulation test is needed.
iii) d) applies only if the manufacturer restricts connection of the SIP or SOP to MEDICAL
# A+ V4 D+ Z' _! ~6 M! n  y* z& fELECTRICAL EQUIPMENT
8 S6 j- p4 X' }
, a' N9 C& l3 @8 b3 [# X+ Q
/ D! D* P+ \; ?  r