1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 11418 1 1: KS P ISO 11418 1:2009 2009 12 17 http:/www.kats.go.krKS P ISO 11418 1:2009 : ( ) ( ) () () ( ) : (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 1:2009 i 20
2、05 2 ISO 11418 1, Containers and accessories for pharmaceutical preparations Part 1: Drop-dispensing glass bottles . KS P ISO 11418 . 1: 2: 3: 4: 5: 7: KS P ISO 11418 1:2009 1: Containers and accessories for pharmaceutical preparations Part 1: Drop-dispensing glass bottles 1 , , . . . . , , . 2 . .
3、( ) . KS A ISO 1101, (GPS) , , 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 titration method and classificat
4、ion ISO 4802 2: 1988, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification ISO 7459: 2004, Glass containers Thermal shock resistance and thermal shock endurance Test methods ISO 8113: 2004, Glass containers Resist
5、ance to vertical load Test method 3 3.1 1 1 . KS P ISO 11418 1:2009 2 , , KS A ISO 1101 . 3.2 . . ISO 4802 HC 3 (cl) 100 mL . KS P ISO 11418 1 100 cl 4 4.1 KS L ISO 719 HGB 3 ISO 720 HGA 2 (cl) (br) 1) 1) . 4.2 4.2.1 ISO 8113 . 4.2.2 ISO 4802 1 ISO 4802 2 ISO 4802 HC 3 . 4.2.3 ISO 7459 , 42 . 5 1(Y
6、) . 1) ISO 4801 1 ISO 4802 2 KS P ISO 11418 1:2009 3 : mm 1 ISO ( ) 2 3 ( ) 4 . 5 / a r3, . b 1 mm 1 1 , ( ) : mm d1h1 mL ( ) mL a h2 h3 h4 h5 r1 r2 r3 r4 t g 5 8.4 0.8 22.5 0.6 50.7 0.6 6 33.5 26 42.2 7.5 3.5 22 1.8 1.0 17 10 14.2 0.85 28 0.6 56.7 0.6 6.5 39.5 28.5 48.2 7.5 4 24 2 1.0 25 15 18.8 1.
7、0 28 0.6 68.2 0.7 7.5 51 38 59.7 7.5 4 24 2 1.0 28 20 23.9 1.0 32 0.7 68.5 0.7 8 51.3 38 60.0 7.5 4 25 2.5 1.0 35 25 29.2 1.0 35 0.7 67.9 0.7 8.5 50.7 38.5 59.4 7.5 5 25 2.5 1.5 38 30 35 1.05 35 0.7 76.6 0.7 10 59.4 46 67.1 7.5 5 25 2.5 1.5 43 50 56.2 1.2 38.6 0.7 93.3 0.8 11 76.1 60 83.8 7.5 5 30 3
8、 1.5 58 75 83.5 1.3 46.1 0.8 98 0.8 12 80.8 62 88.5 7.5 5.5 35 3 2.0 87 100 110 1.5 51.6 0.8 101 0.8 12.5 83.8 60.5 91.5 7.5 6 37 3.5 2.0 90 4 KS P ISO 114181:2009 1: 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 1:2009KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Containers and accessories for pharmaceutical preparations Part 1: Drop-dispensing glass bottles ICS 11.040.20; 11.120