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emailsimon 发表于 2016-1-15 08:58
4 J" C2 m) g7 [( d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 ...
D' L5 O8 V( p' a" u8 {8.5.2.3 是指远离病人的connector的要求,非patient connection.7 k6 d; P9 Z" p" @" F
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但是2-27 and 2-49 给出了一下要求:( z% L( W5 G& T' m. A- l7 v
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201.8.5.2.3 * PATIENT leads0 o/ n) n2 e% B& a5 a- I
Addition:
- y* D7 G2 z W1 C- W! hAny detachable ELECTRODE connector of a LEAD WIRE shall, when separated from the1 k4 k- _. k( o7 Z: \! h
ELECTRODE, have an air clearance between connector pins and a flat surface of at least
) P0 x$ }& @" r9 P# N/ J/ d0,5 mm.
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201.8.5.2.3 * PATIENT leads
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Any connector for electrical connections on a PATIENT lead that is at the end of the lead$ R1 z0 G p/ o& R- |, Y
remote from the ME EQUIPMENT shall be so constructed that said part cannot be connected to8 q& |) H' P% i7 F
earth or possible hazardous voltage while other PATIENT CONNECTIONS of the same" j. c. L% f* \( B
SINGLE FUNCTION or of MULTIPLE FUNCTIONS on the same APPLIED PART contact the PATIENT. For
) b5 E+ t+ r- ^& pAPPLIED PARTS having multiple PATIENT CONNECTIONS any connector in a lead having electrical
/ k! P6 ^6 S" [connections to ME EQUIPMENT shall comply with one of the following requirements:
) J6 V3 o3 w2 Y$ d0 `9 f& \) \8 |: m2 t– the air clearance between connector pins and a flat surface shall be at least 0,5 mm; or
4 g# N" }2 C7 W' r w, ?& E8 d& G– ME EQUIPMENT shall pass the limits of the total PATIENT LEAKAGE CURRENT caused by an& x: t3 M3 [+ n, o
external voltage on the PATIENT CONNECTIONS (see 8.7 and Table 4 of the general
5 n9 Y& [ b& }1 M5 Pstandard) 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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