1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 11418 3 3: (veral) KS P ISO 11418 3:2009 2009 12 17 http:/www.kats.go.krKS P ISO 11418 3:2009 : ( ) ( ) () () ( ) : (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 3:2
2、009 i 2005 2 ISO 11418 3, Containers and accessories for pharmaceutical preparations Part 3: Screw-neck glass bottles(veral) for solid and liquid dosage forms . KS P ISO 11418 . 1: 2: 3: 4: 5: 7: KS P ISO 11418 3:2009 3: (veral) Containers and accessories for pharmaceutical preparations Part 3: Scre
3、w-neck glass bottles (veral) for solid and liquid dosage forms 1 (veral)1) , , . . . . , , . 2 . . ( ) . 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
4、the interior surfaces of glass containers Part 1: Determination by titration 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 ISO 7459: 2004, Glass containers Therma
5、l shock resistance and thermal shock endurance Test methods ISO 8113: 2004, Glass containers Resistance to vertical load Test method 3 3.1 1) “verre allg” KS P ISO 11418 3:2009 2 1 1 . , , KS A ISO 1101 . 3.2 . . ISO 4802 HC 3 (br) 100 mL 28 mm . KS P ISO 11418 3 100 br 4 4.1 KS L ISO 719 HGB 3 ISO
6、720 HGA 2 (cl) (br) 2) 2) . 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 (veral) 1(Y ) . 2) ISO 4801 1 ISO 4802 2 KS P ISO 11418 3:2009 3 : mm 1 ISO ( ) 2 3 ( ) 4 . 5 / a r3, . b 1 mm 1 28 mm (veral) 1 , ( ) : mm d1h1 mL ( ) mL a h2 h3 h4 r1 r2 r3 r4 g 50 60
7、.5 1.1 40.8 0.8 83 0.7 12 64.6 50.6 6 8 25 2.5 59 75 85.8 1.2 47.4 0.8 91.4 0.8 13 73 56.5 6 9 28 2.8 86 100 115.3 1.3 51.6 0.8 98 0.8 14 79.6 60.6 6 9.5 30 3 95 125 144.8 1.3 57 0.9 98 0.8 15 79.6 58.6 6 10 35 3.2 103 150 169.4 1.4 57 0.9 110.4 0.8 15 92 71 6 10 35 3.2 110 200 221.6 1.6 64 1 116 0.
8、9 17 97.6 71.6 6 14 38 3.5 140 250 277.8 1.7 64 1 137.5 0.9 17 119.1 93.1 6 14 38 3.5 168 500 546.9 2.1 82.6 1.3 161.8 1 22 143.4 105 8 18 40 4 270 1 000 1 079 2.7 100.6 1.6 206.2 1.2 24 187.5 140 10 21 45 5 485 4 KS P ISO 114183:2009 3: (veral) 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 3:2009KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Containers and accessories for pharmaceutical preparations Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms ICS 11.040.20; 11.120