DSH 411 General requirements

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DSH 411

General requirements 3 M' l; ?4 ^, J& P( u  l

20.1 * l' H0 j0 [7 y& T1 \

60601-1(ed.2);am1;am2 3 n. ]% |* @; |- O3 i0 m. _, W

Standard(s)- (year and edition):
IEC 60601-1:1988 Ed.2 Am1+Am2
Sub clause(s): 20.1
8 E: T# S# o1 K/ cSheet n°: DSH-411
Subject: General requirements
Key words: Leakage current, SIP/SOP, working voltage, A-k
# [& k$ m$ s2 T- O* ^Confirmed by CTL at its 39th meeting, in Cologne
Question:
, ^% V. K3 r% p$ u7 t: AI) Does exemption a) refer to voltages arising within the EQUIPMENT, to voltages appearing
from external sources, or both?
0 {# |2 e8 Q: vii) Does exemption b) refer to the SFC of mains voltage on the SIP or SOP? Is insulation which
$ V8 b5 b; c6 S" gensures absence of excessive LEAKAGE CURRENTS not to be tested?
: C" R8 a, |) Niii) For exemption d) to apply, does the manufacturer have to restrict connection of the SIP and
# j8 v/ G2 u7 U) n3 D  }/ X1 gSOP to other MEDICAL ELECTRICAL EQUIPMENT or can connection to non-medical
2 U( X( G! [$ j% x$ s# @6 f/ ~9 }equipment be permitted, subject to some restrictions?
5 y6 a# O! o5 F8 Z8 z  S- HDecision:
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.
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
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
& G% S- K2 ]! d* x+ NELECTRICAL EQUIPMENT