DSH 411 General requirements

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DSH 411 * [8 J! |+ J$ S0 ^5 b& F( ^; f! w3 O 3 G/ n, p1 s1 o

General requirements 9 e- ^2 ^4 v& W0 Y/ ^

20.1 ; q' l8 v6 l; I. B

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

  i  f5 O$ M8 X' V. P& cStandard(s)- (year and edition):
IEC 60601-1:1988 Ed.2 Am1+Am2
Sub clause(s): 20.1
Sheet n°: DSH-411
% |0 t; |3 H0 D, r! DSubject: General requirements
Key words: Leakage current, SIP/SOP, working voltage, A-k
Confirmed by CTL at its 39th meeting, in Cologne
Question:
I) Does exemption a) refer to voltages arising within the EQUIPMENT, to voltages appearing
from external sources, or both?
( Z, w- @' A1 t, w% pii) Does exemption b) refer to the SFC of mains voltage on the SIP or SOP? Is insulation which
2 x7 a# B# |- bensures absence of excessive LEAKAGE CURRENTS not to be tested?
" u4 e- ^* @* l! biii) For exemption d) to apply, does the manufacturer have to restrict connection of the SIP and
2 d+ V( N, D7 DSOP to other MEDICAL ELECTRICAL EQUIPMENT or can connection to non-medical
* M% c& f$ N- j6 c: b1 y# U) tequipment be permitted, subject to some restrictions?
) r6 `9 M, u7 q) J8 [3 J0 xDecision:
; Q$ z  l+ u2 c6 @1 g7 u% m! Ii) 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.
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
& p8 W! q; g% K- fproduce 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
ELECTRICAL EQUIPMENT
* ~% g# r1 R/ ^% V