KS P ISO 11418-7-2009 Containers and accessories for pharmaceutical preparations－Part 7：Screw-neck vials made of glass tubing for liquid dosage forms《药品配制用容器及附件 第7部分 液体配药用玻璃管制螺纹颈药水.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 11418 7 7： KS P ISO 11418 7:2009 2009 12 17 http:/www.kats.go.krKS P ISO 11418 7:2009 : ( ) ( ) () () ( ) : (http:/www.standard.go.kr) ： ：2004 12 18 ：2009 12 17 2009-0823 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 11418 7:2009 i 19

2、98 1 ISO 11418 7, Containers and accessories for pharmaceutical preparations Part 7： Screw-neck vials made of glass tubing for liquid dosage forms . ISO 11418 . 1： 2： 3： 4： 5： 7： KS P ISO 11418 7:2009 7： Containers and accessories for pharmaceutical preparations Part 7： Screw-neck vials made of glas

3、s tubing for liquid dosage forms 1 , . . , . 2 . . ( ) . KS L ISO 719, 98 ISO 720： 1985, Glass Hydrolytic resistance of glass grains at 121 Method of test and classification ISO 4802 1： 1988, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 1： Determination by titrat

4、ion method and classification ISO 4802 2： 1988, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2： Determination by flame spectrometry and classification 3 3.1 1 1 . KS P ISO 11418 7:2009 2 ： mm AR b p k d5 ()+ 31234kpd R1 0.366 b d5 b c k 0.675( ) p a , h3 d2 . , .

5、 h3 . d2 . . 0.3 mm . 1 (knuckle thread) 3.2 “ ”, , Glt, . 10 ISO 4802 HC 1 . KS P ISO 11418 7 Glt 10 br 1 a KS P ISO 11418 7:2009 3 4 ISO 4802 1 ISO 4802 2 (cl) (br) . ISO 720 HGA 1 ISO 720 HGA 2 KS L ISO 719 HGB 3 5 5.1 . 5.2 . 6 6.1 ISO 4802 1 ISO 4802 2 . ISO 4802 HC 1 ISO 4802 HC 2 ISO 4802 HC

6、3 6.2 , , mm 40 nm . 6.3 . . 7 (symbol) . . 8 , . 1 , ( ) , ： mm d1d2cd3d4h1h2h3r1r2aS1S2bt ( ) mL a d p R1R2 0.50.053.02.0+ g 5 6.5 1.0 142.5 18 0.20 8.6 0.20 12.3 0.4 0.62 0.25 14.0 0.4 45 0.5 29 10.5 3.011.50.5 1.2 0.8 0.5 0.3 7.5 7.5 9.0 1.2 183.0 22 0.20 11.5 0.20 16.0 0.5 0.74 0.3 18.0 0.5 40

7、0.5 23 11.0 3.512.00.5 1.2 0.8 0.5 0.3 9.4 10 12.5 1.2 183.0 24 0.20 11.5 0.20 16.0 0.5 0.74 0.3 18.0 0.5 45 0.5 28 11.0 3.512.00.5 1.2 0.8 0.5 0.3 11.2 15 17.5 1.2 183.0 24 0.20 11.5 0.20 16.0 0.5 0.74 0.3 18.0 0.5 60 0.5 43 11.0 3.512.00.5 1.2 0.8 0.5 0.3 14.6 20 25.5 1.5 223.0 30 0.30 15.2 0.25 2

8、0.0 0.5 0.74 0.3 22.0 0.5 55 0.7 36 11.0 5.51.5 2.51 1.2 0.8 0.6 0.4 17.5 25 31.5 1.5 223.0 30 0.30 15.2 0.25 20.0 0.5 0.74 0.3 22.0 0.5 65 0.7 46 11.0 5.51.5 2.51 1.2 0.8 0.6 0.4 19.8 30 37.5 1.5 223.0 30 0.30 15.2 0.25 20.0 0.5 0.74 0.3 22.0 0.5 75 0.7 56 11.0 5.51.5 2.51 1.2 0.8 0.6 0.4 22.5 a ,

9、r2 1 . . b 0.5 mm . c , d2 . . 4 KS P ISO 114187:2009 7： 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 11418 7:2009KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Containers and accessories for pharmaceutical preparations Part 7： Screw-neck vials made of glass tubing for liquid dosage formsICS 11.040.20; 11.120