KS P ISO 10985-2009 Caps made of aluminium-plastics combinations for infusion bottles and injection vials－Requirements and test methods《输液瓶和注射药瓶用铝和塑料复合物制成的帽盖 要求和试验方法》.pdf

1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 10985 - KS P ISO 10985 :2009 2009 12 7 http:/www.kats.go.krKS P ISO 10985:2009 : ( ) ( ) () () ( ) : (http:/www.standard.go.kr) ： ： 2004 12 18 ： 2009 12 7 2009-0762 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 10985:2009 - Caps made

2、 of aluminium-plastics combinations for infusion bottles and injection vialsRequirements and test methods 2009 3 ISO 10985, Caps made of aluminium-plastics combinations for infusion bottles and injection vialsRequirements and test methods , . 1 KS P ISO 85361 / ISO 83621 KS P ISO 83624 KS P ISO 8536

3、7 KS P ISO 83626 - . . a) b) / () c) d) / 2 . . ( ) . KS B ISO 75001, 1：/ KS P ISO 83624, 4： KS P ISO 83626, 6： - KS P ISO 85361, 1： KS P ISO 85367, 7： - KS P ISO 8872, , KS P ISO 10985:2009 2 ISO 83621：2003, Injection containers and accessoriesPart 1：Injection vials made of glass tubing 3 3.1 KS P

4、ISO 8872 3. . 3.2 3.2.1 . 121 30 , 130 ( 5 ) . 3.2.2 . . 3.3 - . 4 4.1 KS P ISO 8872 4.1 4.4 . 4.2 - 4.2.1 4.2.1.1 / , 100 N 100 mm/min (v) , 1 KS B ISO 75001 1 4.2.2 1 1 . . . KS P ISO 10985:2009 3 1 2 3 () 1 1 ：mm KS P ISO 83626 KS P ISO 85367 R b 13 8 8 20 12 10 28 16 12 32 20 15 4.2.3 2 (mandrel

5、) . 2 (tear-out ring) ( .) . / (4.2.1.1) . . . KS P ISO 10985:2009 4 1 2 (mandrel) 2 (tear-off force) 2 ：mm KS P ISO 83626 KS P ISO 85367 d 1R 13 13.1 0.8 20 20.1 0.8 28 27.9 1.15 32 32.4 1.15 5 , , KS P ISO 8872 5. . 6 KS P ISO 8872 . 7 KS P ISO 8872 . 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO 10985 :2009 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Caps made of aluminium-plastics combinations for infusion bottles and injection vials Requirements and test methods ICS 11.040.20 Korean Agency for Technology and Standards http:/www.kats.go.kr