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

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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

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