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发表于 2016-1-15 09:49
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emailsimon 发表于 2016-1-15 08:58
; f. {# C$ F, V比如监护仪的ECG lead的电极认为是patient connection, 但是电极裸露的导电部件还是可以接触到SIP/SOP, en ... 3 y9 a3 k, c, `) ~& | Z9 _
8.5.2.3 是指远离病人的connector的要求,非patient connection.
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2 A* r+ b6 x( S4 U4 Q! E& N但是2-27 and 2-49 给出了一下要求:6 t# ^7 i! f$ `
, ?' p0 ]8 Q+ ~% x201.8.5.2.3 * PATIENT leads
* h. f; r3 D% ~% e! O* EAddition:/ m7 ?& e+ Z6 l8 B% S
Any detachable ELECTRODE connector of a LEAD WIRE shall, when separated from the
) H5 r& Y! w/ `7 p, `: w8 x% I* r0 {* EELECTRODE, have an air clearance between connector pins and a flat surface of at least# c; c4 Q& l9 H K) M
0,5 mm.
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201.8.5.2.3 * PATIENT leads$ Y& r1 U2 y" M; u5 ?5 D
Addition:- M6 V) s z" _
Any connector for electrical connections on a PATIENT lead that is at the end of the lead
c" t5 v' I4 D3 {# Yremote from the ME EQUIPMENT shall be so constructed that said part cannot be connected to3 D0 x; }9 M' [0 |; p# ~, f
earth or possible hazardous voltage while other PATIENT CONNECTIONS of the same
. Y$ _9 M: a2 C" dSINGLE FUNCTION or of MULTIPLE FUNCTIONS on the same APPLIED PART contact the PATIENT. For
3 c4 F7 E9 o$ s& w6 FAPPLIED PARTS having multiple PATIENT CONNECTIONS any connector in a lead having electrical
! A& r' I" X4 k8 Iconnections to ME EQUIPMENT shall comply with one of the following requirements:
# m! {: {# G2 ^2 O6 q8 h– the air clearance between connector pins and a flat surface shall be at least 0,5 mm; or
( x: q |0 z$ v8 q8 g, J/ R– ME EQUIPMENT shall pass the limits of the total PATIENT LEAKAGE CURRENT caused by an
/ Y& W9 s3 v) J1 q. W1 c( I0 Dexternal voltage on the PATIENT CONNECTIONS (see 8.7 and Table 4 of the general
$ O6 I$ R& H, y: t/ ]standard) when measured between different SINGLE FUNCTIONS (see Figure CC.3).
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我觉得60601-1部分的说法是存在一定的bug,但是在专标里面,根据产品的实际使用情况,又把这个bug给补上了。 |
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