1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 11318 DF-1 KS P ISO 11318:2012 2012 12 27 http:/www.kats.go.krKS P ISO 11318:2012 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) : :2002 6 29 :2012 12 27 2012-0767 : : ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO 11318:2012 i ii . iii 1
2、1 2 1 3 .1 4 2 A( ) 8 B( ) 12 C( ) 15 D( ) .17 E( ) .18 KS P ISO 11318:2012 ii . KS P ISO 11318: 2007 . . , , . , , . KS P ISO 11318:2012 iii 2002 2 ISO 11318, Cardiac defibrillators Connector assembly DF-1 for implantable defibrillators Dimensions and test requirements , . KS P ISO 11318:2012 DF-1
3、Cardiac defibrillators Connector assembly DF-1 for implantable defibrillators Dimensions and test requirements 1 1 kV/50 A DF-1 . . . . , . 2 . . ( ) . KS B ISO 7436: 2007, 3 . 3.1 (connector cavity: ) 3.2 3.3 KS P ISO 11318:2012 2 3.4 3.5 3.6 ( ) 3.7 GO 3.8 GO 3.9 3.10 3.11 3.12 3.13 3.14 4 4.1 ( )
4、 . . . KS P ISO 11318:2012 3 . 4.2 4.2.1 4.2.1.1 , 1 . 4.2.1.2 1 . : mm 1 2 3 a , . b1 2 A 0.13 mm . c 3.230.1 . d e f 3.231.02.0+g , 4.1 mm h , 120 . 1 DF 1 KS P ISO 11318:2012 4 4.2.2 4.2.2.1 2 GO . 14 N . 1 . : mm : m 1 2 3 : a . 2 DF-1 GO 4.2.2.2 , 4.2.2.1 . . 2 GO . KS B ISO 7436 M2 1( 2) , (0.
5、150.01) N m . (6010) (151)N , . 4.2.2.1 . KS P ISO 11318:2012 5 4.2.2.3 . A . 4.2.3 . 3 “DF-1” . 3 4.3 4.3.1 4.3.1.1 , 4 . A . 4.3.1.2 4 . 4.3.2 4.3.2.1 5 GO . 9 N . 4 . 4.3.2.2 . B . 4.3.3 3 “DF-1” . KS P ISO 11318:2012 6 : mm 1 2 3 a 4.3.2.1 . b . c 1.311.00+ . d 1.31 min. . e 3.43 min. . f 2.05 m
6、m/min . 4 DF 1 KS P ISO 11318:2012 7 : mm : m 1 5 DF 1 GO KS P ISO 11318:2012 8 A ( ) A.1 ( ) . , . A.2 A.1 . a) ( A.2). b) 10 % 90 % , (1.50.5) s , dV/dT 2 kV/s . c) 18 ms , 10 s . d) 1.5 kV5 % , 18 ms 750 V . e) 500 mm2 9 g/L 50 200 mm . A.3 . A.4 A.4.1 9 g/L ( A.3) , 0.07 mm . 10 (375) . A.4.2 ,
7、, , 9 g/L , . 10 (375) . A.4.3 . . . KS P ISO 11318:2012 9 (50050) . A.5 10 , ( A.5). a) 4 s 1 ms 100 mA . b) 1 ms 20 mA . : mm a Cl 1 F A.1 50200 mmKS P ISO 11318:2012 10 A.2 : mm 1 : 2 0.07 mm . A.3 1.5 kV5 %1.5 kV5 % KS P ISO 11318:2012 11 : mm : m a: b: A.4 a1 ms b4 s 1 ms c A.5 KS P ISO 11318:2
8、012 12 B ( ) - B.1 ( ) . , . B.2 B.2.1 ( B.1) B.2.2 ( B.2) : mm 1 a: b: c B.1 B.3 . KS P ISO 11318:2012 13 a200 F . b , . . B.2 B.4 . . . a) (375) . b) ( , , , ) . B.2 (feed through) ( ). c) 200 F10 % (1 000100) V ( B.2 ). , 25 ms 15 5 % . 10 . d) (50050) c) , . B.5 10 , bKS P ISO 11318:2012 14 ( B.
9、3 ). a) . b) 4 s 65 V . , 4.3.2.1 . a4 s b B.3 a bKS P ISO 11318:2012 15 C ( ) C.1 . . , . 0.095 mm . , 0.095 mm . C.2 (50050) . . , 10 10 . . . 491 500 “ ” . . 400 . C.3 (1.50.5) s . . 18 ms 1.5 (1kV ). 700 V 800 V . , . , . . ( 2:1 ) 1.5:1 . C.4 4 s . 4 s KS P ISO 11318:2012 16 . , . 1 ms 100 mA ,
10、 . 17 ms 20 mA , . A.1 R2 VR1 . KS P ISO 11318:2012 17 D ( ) D.1 . , , , . D.2 (50050) . . D.3 . . 15 1 000 V , . 200 F 100 J . 25 ms ( 200 F 16 ms ). D.4 4 s . 0 3 ms , (degradation) . . 65 V 1 . 40 2 , 5 % . . D.5 . KS P ISO 11318:2012 18 E ( ) E.1 , . , , . , . E.2 , . (IS 1 ) . , . DF 1 , , . ,
11、. . . , . , . . , . E.3 . . a) “ ” . . b) 1 . 0.1 mm “ ” KS P ISO 11318:2012 19 . , 1. . , , . A . . . , 4.2.2.1 . c) ( A) . ISO 11318 , 2:1 . “bulk” . DF-1 . , . IS-1 . . IS-1 DF-1 . , . . . d) ISO / IEC 2 . e) A.4 0.1 mm “ ” . f) B.1 0.1 mm “ ” . E.4 E.4.1 (4.2.1.2 4.3.1.2) 4 0.51 mm . . / . (IS-1 ). .