DSH 411 General requirements

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DSH 411 " L6 J5 d/ v% ~) C7 t6 j  N1 H0 F

General requirements

20.1

60601-1(ed.2);am1;am2

Standard(s)- (year and edition):
IEC 60601-1:1988 Ed.2 Am1+Am2
$ G& a9 v8 ]* r, r" }Sub clause(s): 20.1
* p% X2 J. U1 b6 b: C: g6 y6 SSheet n°: DSH-411
Subject: General requirements
Key words: Leakage current, SIP/SOP, working voltage, A-k
+ d% x6 W$ v/ b8 o  Z6 ]Confirmed by CTL at its 39th meeting, in Cologne
Question:
I) Does exemption a) refer to voltages arising within the EQUIPMENT, to voltages appearing
9 H4 t# y. a& m8 Z1 d! }from external sources, or both?
ii) 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?
- p- `; z4 W" N9 x7 ]iii) For exemption d) to apply, does the manufacturer have to restrict connection of the SIP and
4 G" d+ t/ c, k% G5 |% o* nSOP to other MEDICAL ELECTRICAL EQUIPMENT or can connection to non-medical
( r0 a1 I& d% L& d: s$ Eequipment be permitted, subject to some restrictions?
) t" Z* J. f$ UDecision:
i) a) applies only if the voltages within the SIP and SOP are less than SELV when connected to
EQUIPMENT consistent with the instructions for use.
3 M2 n2 ?  M! ?ii) b) applies to a SFC resulting from a single component failure within the SIP or SOP in
NORMAL USE i.e. connected as specified in the instructions for use. If such a SFC does not
$ ~6 x0 V" n! n2 \- `: c. Q; R' `3 hproduce excessive LEAKAGE CURRENTS then no additional insulation test is needed.
- r, v) \8 G) [' k% p+ Yiii) d) applies only if the manufacturer restricts connection of the SIP or SOP to MEDICAL
ELECTRICAL EQUIPMENT
2 Y6 i0 Q# L9 F; x8 x
( l* i$ `! |* ^# }% _2 [
* C; s( T, s. ?1 U9 F