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emailsimon 发表于 2016-1-15 08:58
: r( u0 `% D/ H. k3 _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 ...
6 J5 u4 }$ K4 S4 J+ Z2 c8.5.2.3 是指远离病人的connector的要求,非patient connection.
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1 r8 M" q# Z5 d3 l4 H但是2-27 and 2-49 给出了一下要求:9 k: k: n# t) I* n
E n6 s, [% u1 x, J4 n201.8.5.2.3 * PATIENT leads7 {) k3 T+ C8 @0 Z C P
Addition:
# {4 t" C9 J/ V1 gAny detachable ELECTRODE connector of a LEAD WIRE shall, when separated from the
2 C9 I" b) I- l/ I& @ELECTRODE, have an air clearance between connector pins and a flat surface of at least
7 e- w K: e; u+ x+ U g h* K. o0 X8 {0,5 mm.
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8 j9 w8 r4 m* _# l$ p8 |201.8.5.2.3 * PATIENT leads5 {- w Q- ?" L
Addition:, N3 n9 ^4 |' Q& i$ K; Q0 _
Any connector for electrical connections on a PATIENT lead that is at the end of the lead2 c- @/ ^$ l0 f; @2 y4 N
remote from the ME EQUIPMENT shall be so constructed that said part cannot be connected to4 y/ `0 T! _8 c8 R; [/ R2 ?( r
earth or possible hazardous voltage while other PATIENT CONNECTIONS of the same
0 u5 p; `. o# ?5 ySINGLE FUNCTION or of MULTIPLE FUNCTIONS on the same APPLIED PART contact the PATIENT. For
; G6 F% [/ _3 Z8 U: r( ^; M9 DAPPLIED PARTS having multiple PATIENT CONNECTIONS any connector in a lead having electrical. P' e+ S! K7 e# Q+ |4 ^
connections to ME EQUIPMENT shall comply with one of the following requirements:
% ]* S! a- {/ b* w9 U. ^– the air clearance between connector pins and a flat surface shall be at least 0,5 mm; or+ z1 {. L# w) ]6 `: x: s
– ME EQUIPMENT shall pass the limits of the total PATIENT LEAKAGE CURRENT caused by an( J+ [2 O5 o. k8 |
external voltage on the PATIENT CONNECTIONS (see 8.7 and Table 4 of the general+ y* B+ b s# o7 F2 l( K0 ~
standard) when measured between different SINGLE FUNCTIONS (see Figure CC.3).- \; a h0 k r. ]+ Y# g# }
* Q; q$ ^# b5 K5 ~$ y1 U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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