KS P ISO 11418-2-2009 Containers and accessories for pharmaceutical preparations－Part 2：Screw-neck glass bottles for syrups《药剂容器及附件 第2部分 糖浆用螺口玻璃瓶》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 11418 2 2： KS P ISO 11418 2:2009 2009 12 17 http:/www.kats.go.krKS P ISO 11418 2:2009 : ( ) ( ) () () ( ) : (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 2:2009 i 20

2、05 2 ISO 11418 2, Containers and accessories for pharmaceutical preparations Part 2： Screw-neck glass bottles for syrups . KS P ISO 11418 . 1： 2： 3： 4： 5： 7： KS P ISO 11418 2:2009 2： Containers and accessories for pharmaceutical preparations Part 2： Screw-neck glass bottles for syrups 1 ( ) , , . .

3、. . , , . 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 the interior surfaces of glass containers Part 1： Determination by titration method

4、 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 Thermal shock resistance and thermal shock endurance Test methods ISO 8113： 2004, Glass c

5、ontainers Resistance to vertical load Test method 3 3.1 1 1 . KS P ISO 11418 2:2009 2 , , KS A ISO 1101 . 3.2 . . ISO 4802 HC 3 (cl) 500 mL 28 mm . KS P ISO 11418 2 500 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

6、ISO 7459 , 42 . 5 1(Y ) . 1) ISO 4801 1 ISO 4802 2 KS P ISO 11418 2:2009 3 ： mm 1 ISO ( ) 2 3 ( ) 4 . 5 / a r3, . b 1 mm 1 28 mm 1 , ( ) ： mm d1h1 mL ( ) mL a h2 h3 h4 r1 r2 r3 r4 g 30 35.7 0.9 35 0.7 67 0.8 8.8 48.6 30.4 6.5 29 18 2.5 39 50 55.3 1.1 38.6 0.7 85.4 0.8 10 67 43.6 5.5 38 19 3 55 60 65

7、.7 1.2 38.6 0.7 94 0.8 10 75.7 52.3 5.5 38 19 3 60 75 81 1.2 43.9 0.7 95 0.8 11.3 77.1 49.3 6 39 19.5 3 67 90 95.2 1.35 43.9 0.7 103.1 0.8 11.3 84.9 59.8 5.9 32 19.6 3 69 100 105.5 1.35 46.1 0.8 104.8 0.9 11.7 86.4 58.3 6.5 36 19.6 3.5 69 125 133 1.5 49 0.8 114.4 0.9 12.5 96 65.9 5 38.7 21.5 3.5 83

8、150 156.6 1.6 51.6 0.8 122.8 0.9 13 104.4 73.9 8 33.6 23 3.5 98 180 189.1 1.7 54.7 0.9 129.9 1 14 111.5 78.5 9 35.1 24 4 112 200 209.8 1.7 57 0.9 133.3 1 14.5 114.4 79.4 10.5 35.8 25 4 123 250 261.1 1.85 61.7 1 142.9 1 15.5 124 84 12 40.8 26.5 4.5 145 300 314.4 1.95 65.6 1 151.3 1 16.5 132.4 91.4 13

9、 38.6 28 5 172 500 522.2 2.3 76.8 1.2 176.8 1.1 19 157.9 106 8 57 32.5 5.5 252 1 000 1 025 2.8 97.5 1.5 215.3 1.3 24 196.7 124.7 17 72.5 41 7 455 4 KS P ISO 114182:2009 2： 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 2:2009KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Containers and accessories for pharmaceutical preparations Part 2： Screw-neck glass bottles for syrups ICS 11.040.20； 11.120