DSH 411 General requirements

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DSH 411   a+ e" J1 G7 w# ^

General requirements ' k. ?2 E" g7 w' }5 J4 B; T

20.1 7 {7 {* h" d+ y! M$ [

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

- A* k- Y- V- c) _( XStandard(s)- (year and edition):
IEC 60601-1:1988 Ed.2 Am1+Am2
Sub clause(s): 20.1
+ J6 O8 k- J/ `+ Q3 KSheet n°: DSH-411
/ A/ I% w, r6 r2 {Subject: General requirements
Key words: Leakage current, SIP/SOP, working voltage, A-k
Confirmed by CTL at its 39th meeting, in Cologne
Question:
  ^; K7 O1 S' hI) Does exemption a) refer to voltages arising within the EQUIPMENT, to voltages appearing
from external sources, or both?
+ J+ r9 ~* Q2 _, n6 i% ?1 vii) 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?
# A7 d: p  b  X, E6 Kiii) For exemption d) to apply, does the manufacturer have to restrict connection of the SIP and
SOP to other MEDICAL ELECTRICAL EQUIPMENT or can connection to non-medical
equipment be permitted, subject to some restrictions?
Decision:
' x7 ?1 i3 l. n* H: d" N. g) ]i) a) applies only if the voltages within the SIP and SOP are less than SELV when connected to
$ K' ~- C( T; G( y9 R6 T! ~EQUIPMENT consistent with the instructions for use.
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
) O3 P4 i8 m' x& N! Jproduce excessive LEAKAGE CURRENTS then no additional insulation test is needed.
$ f' A+ D# U" I  `/ w/ hiii) d) applies only if the manufacturer restricts connection of the SIP or SOP to MEDICAL
  D7 L  b, A0 A" B* [ELECTRICAL EQUIPMENT

6 z' w) Q9 p; f" F