KS P ISO 11418-1-2009 Containers and accessories for pharmaceutical preparations－Part 1：Drop-dispensing glass bottles《药剂容器及附件 第1部分 玻璃点滴瓶》.pdf

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