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bossingyang 发表于 2015-7-14 17:00  . D. t9 S1 N' B* }$ ]$ p
谢谢关注~
8 E3 B8 j0 F$ j4 Z7 v; _如果按照应用部分来处理，那么应用部分与SIP/SOP直接不需要绝缘了;
' Q' E6 G4 ?, X# N6 J" y但是SIP/SOP连接的比如 ...
- }* \6 c) {# s! Y认证工程师和制造商因为在不同的角度看问题，有时会处理的方案也不同。
7 R& Z3 d) L6 P" {% ~9 h) x我觉得他的潜台词就是所有的SIP/SOP都按照AP做隔离，这对他们来说比较方便处理。
5 W+ [4 _, E% A& m) W对于认证工程师来说有时候最难的是在标准含糊不清的情况下该如何处理分类，太严了厂家会反弹，太放松自己又不放心， 报告review时说不定还通不过，很麻烦。! ?# ?8 ?: I- \
6 r) P/ h2 R/ H e% e不过刚刚看到一段话，是在IEC 60601-1附录A中的解释中提到的：/ |/ e9 W5 B/ |8 Y% r+ Y
Subclause 4.6 would likely not apply to ACCESSIBLE PARTS of ME EQUIPMENT which are* ~1 J4 B2 }- q# k/ }6 @; s4 ^
positioned according their INTENDED USE in such a way that the PATIENT could touch them only& ]" ]$ r- k. x3 [5 Q
by a deliberate movement. This is based on the assumption that a PATIENT could react to a
w" L: m; f ], q) {negative stimulus. Further, such PATIENTS are likely to have contact with non-ME EQUIPMENT
+ S5 X# l4 ] ]/ V usuch as bedside lights, personal computers, radios, etc.
: O1 x! e, k/ k+ ?3 Q4 V) d
; B' ]; A* y R9 G8 H. ^IEC 60601-1:2012， page number 286/287 Figure A.7/A.6, 提供了两个很好的例子可以参考。
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另外IEC 60601-2-47：2011 提到以下：
2 w' q; \+ K5 @% x201.3.202
! ^5 e+ k* p, o4 W; P5 t# f) _* sAMBULATORY ELECTROCARDIOGRAPHIC SYSTEM
5 G& y; P$ y2 s. T8 LME SYSTEM, AMBULATORY RECORDER and a PLAYBACK EQUIPMENT, both of which may contain an
, t/ k, A4 X# U' ]analysis function
: q2 G6 H: x- F! W, jNote 1 to entry: This ME SYSTEM is often referred to as Holter monitoring system after its inventor
& g% _" r& e _) lDr. Norman Holter.' R `1 j: j: m+ o
201.3.203) \/ C- M7 v' ? z; \: S
AMBULATORY RECORDER
5 K Y$ _6 \* {3 J% Yrecording ME EQUIPMENT worn or carried by the PATIENT including associated ELECTRODES and! l" Y3 R P- c
cables for recording heart action potentials
1 _. W# g! m$ V; J6 M7 wNote 1 to entry: An AMBULATORY RECORDER may also analyse the heart action potentials. It may record selectively
$ y \" p: v$ c7 iwhen significant events are detected, or continuously.! D/ D; C2 Z6 p
. X5 B) [" _. n5 n201.3.2038 N+ g I: F1 s" x$ y( A$ |
AMBULATORY RECORDER
" @" h7 f% P- H8 y8 Srecording ME EQUIPMENT worn or carried by the PATIENT including associated ELECTRODES and# ^+ P# _$ K) t
cables for recording heart action potentials
3 _- _+ }% A2 n% _# }! x4 s/ ~Note 1 to entry: An AMBULATORY RECORDER may also analyse the heart action potentials. It may record selectively3 K9 P; G! S, x
when significant events are detected, or continuously.
7 ?1 J: I3 R* [; ~; p. C5 @. Q8 [; \* A' E7 c- E7 g R) v
201.3.2159 U2 Y, \; l1 O, U7 G0 K" B
PLAYBACK EQUIPMENT5 P% F; {2 @" g' W
equipment with monitoring and documenting functions into which ECG and measurements" P, e1 E# ~+ L0 G; I8 Y) o
derived from the AMBULATORY RECORDER are fed
8 K! h7 s6 ^0 {" O, vNote 1 to entry: This ME EQUIPMENT is usually stationary and commonly includes computing facilities.7 Z2 Q3 a8 K# N" X
' v, \% m9 I% s- a2 W3.112' ?/ M1 c7 E& M1 y
* SEPARATION DEVICE
4 {. v* M" S% {$ F( X6 Fcomponent or arrangement of components with input parts and output parts that, for safety
# a" A" ~/ x3 j, J: L2 Lreasons, prevents a transfer of unwanted voltage or current between parts of an ME SYSTEM
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注意看这里！！！！
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201.16.5 SEPARATION DEVICES7 r0 y, r) J+ C- X. X
Addition:& a6 |# z# M# a T, A! ]: b1 Z
If the AMBULATORY RECORDER may be connected simultaneously to the PLAYBACK EQUIPMENT
; @- k. b |4 V% S) D, s- w6 ?and the PATIENT, a SEPARATION DEVICE shall be provided.0 e& H8 f+ ?( g. r' v; T2 l- G
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发表于 2015-7-14 10:18
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，谢谢lxxcumt, a; i4 d' u* M