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| DSH 411+ p, k$ ^% R; a, b+ d+ R8 e
' ?, a% M0 a. [8 \3 } | General requirements8 g0 y- R, u8 D- L3 ]8 v
| 20.13 {( j: A J0 m2 B, l, M
| 60601-1(ed.2);am1;am2+ B) k% M5 d: i0 M0 N
| # x, k/ u4 {$ \, X1 k
Standard(s)- (year and edition):
0 Q5 `- m/ r+ V! c% d& \IEC 60601-1:1988 Ed.2 Am1+Am22 b, \! b+ X' n5 }, n( D
Sub clause(s): 20.1
6 P$ w% M7 @! uSheet n°: DSH-4119 j7 P1 H; ]( c+ r- f# j8 J
Subject: General requirements/ [8 f8 \3 b( k o. J& _ v* S! `5 |
Key words: Leakage current, SIP/SOP, working voltage, A-k7 C- K+ ?* U- [ i
Confirmed by CTL at its 39th meeting, in Cologne
5 z% C2 b8 o6 {% w% R1 `Question:. ? E6 U0 W* h3 X
I) Does exemption a) refer to voltages arising within the EQUIPMENT, to voltages appearing
4 \& \ w- s L& Hfrom external sources, or both?
9 a; w6 H/ T* V* A$ oii) Does exemption b) refer to the SFC of mains voltage on the SIP or SOP? Is insulation which' i* X) N! b) i9 q. o- P
ensures absence of excessive LEAKAGE CURRENTS not to be tested?# c9 x q* {) V$ z
iii) For exemption d) to apply, does the manufacturer have to restrict connection of the SIP and
9 E4 T: G$ N% D6 I1 j! xSOP to other MEDICAL ELECTRICAL EQUIPMENT or can connection to non-medical
) u0 ?: T! P A9 d7 t0 nequipment be permitted, subject to some restrictions?( S; g. |$ Y k: M' a
Decision:
* |* i, B" e, @ A! p) gi) a) applies only if the voltages within the SIP and SOP are less than SELV when connected to
- Q! ?0 [/ {9 X1 d* F+ R0 Y6 B7 e: uEQUIPMENT consistent with the instructions for use.2 Z6 e* [. k& U. S+ F
ii) b) applies to a SFC resulting from a single component failure within the SIP or SOP in/ @/ w- I! {& W2 W
NORMAL USE i.e. connected as specified in the instructions for use. If such a SFC does not
7 v) G, A" x$ ^+ D- F) kproduce excessive LEAKAGE CURRENTS then no additional insulation test is needed.
% L s4 y% `5 [2 uiii) d) applies only if the manufacturer restricts connection of the SIP or SOP to MEDICAL2 Y6 m$ j- Z5 `, x* ]* e, j
ELECTRICAL EQUIPMENT
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