KS P ISO 11418-3-2009 Containers and accessories for pharmaceutical preparations－ Part 3：Screw-neck glass bottles (veral) for solid and liquid dosage forms《药剂容器及附件 第3部分 固体和液体药剂用螺口玻.pdf

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