1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P 8004 KS P 8004:2009 2009 12 7 http:/www.kats.go.krKS P 8004:2009 : ( ) ( ) ( ) ( ) ( ) : (http:/www.standard.go.kr) ： ：1979 12 24 ：2009 12 7 2009-0762 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P 8004:2009 i . KS P 8004： 2004 . . , , . , , .
2、 KS P 8004:2009 Intravenous infusion set 1 ( .) 1 ( .) . 2 . . ( ) . KS P 3001, 1 KS P 8006, ISO 10993 7, Biological evaluation of medical devices Part 7： Ethylene oxide sterilization residuals 3 a) , , . 210 m(70 ) , . b) KS P 3001 17 27 , 21 . c) . d) , . , , . e) 10 % , , . f) . g) , . , . 4 ( )
3、KS P 8006 4. , 6.1 KS P 8004:2009 2 6.2 . 5 . a) b) c) d) e) (EO： Ethylene Oxide) 6 6.1 KS P 8006 6.1 6.2 . 6.2 . 6.2.1 KS P 8006 6.2.1 . 6.2.2 KS P 8006 6.2.2 , . 6.2.3 KS P 8006 6.2.3 , . 6.2.4 KS P 8006 6.2.4 , . 6.2.5 ISO 10993 7 (EO) 25 ppm, (ECH) 25 ppm . , EO . 7 . 8 . KS P 8004:2009 3 a) b) “ ” c) d) e) f) g) 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P 8004:2009 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Intravenous infusion set ICS 11.040.20 Korean Agency for Technology and Standards http:/www.kats.go.kr
