|
emailsimon 发表于 2016-1-15 08:58 : u2 y7 d" t4 r5 E9 _& f+ e
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 ...
! F+ g" m* F% D8 D8.5.2.3 是指远离病人的connector的要求,非patient connection.
# O) S3 h# N' p, f. ~+ Q* B( ]& ?0 ^/ Q2 v9 {( l( _& Z
但是2-27 and 2-49 给出了一下要求:
0 [' n) t- B B$ A2 u5 Q% S
4 j2 K2 {# _& i) ?, g201.8.5.2.3 * PATIENT leads
$ M( `; O! K& v& g! E5 m, l: d" z& \Addition:0 l2 G& S, C/ g8 R- S
Any detachable ELECTRODE connector of a LEAD WIRE shall, when separated from the
; a6 N: X, ?# [2 m v# q, PELECTRODE, have an air clearance between connector pins and a flat surface of at least2 A5 x4 ^3 Y+ O: T. K: s) v
0,5 mm.
0 l$ O( \+ Q5 C! o" G9 ^7 y. J% @9 L- S) Z
201.8.5.2.3 * PATIENT leads) S$ b. J( x- t) [3 f; y
Addition:. E% S0 I9 I% s( i* H
Any connector for electrical connections on a PATIENT lead that is at the end of the lead0 U, \8 I/ L- A
remote from the ME EQUIPMENT shall be so constructed that said part cannot be connected to y8 N3 Z: {6 [, `* s8 b* I
earth or possible hazardous voltage while other PATIENT CONNECTIONS of the same
& Z0 k4 A# \. r5 q# W5 wSINGLE FUNCTION or of MULTIPLE FUNCTIONS on the same APPLIED PART contact the PATIENT. For
- ]& ]+ F) b4 N. G' Y; m; s0 _' kAPPLIED PARTS having multiple PATIENT CONNECTIONS any connector in a lead having electrical
4 J+ d. U& r6 M, fconnections to ME EQUIPMENT shall comply with one of the following requirements:
0 A! p$ r$ c% }2 n– the air clearance between connector pins and a flat surface shall be at least 0,5 mm; or" C a! u2 A! }% _: F# |5 n/ ^
– ME EQUIPMENT shall pass the limits of the total PATIENT LEAKAGE CURRENT caused by an
3 z1 F+ S2 a- V; x5 m! y: m! rexternal voltage on the PATIENT CONNECTIONS (see 8.7 and Table 4 of the general
0 I8 i! s) }0 ?# x1 Z/ vstandard) when measured between different SINGLE FUNCTIONS (see Figure CC.3).
7 n7 `) f, e- o+ _9 \
J0 O* S# [& e' y; q# Z+ i) _3 d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。 |
|