KS P ISO 11040-4-2009 Prefilled syringes－Part 4：Glass barrels for injectables《预灌装注射器 第4部分 血管注射剂用玻璃圆柱体》.pdf

1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 110404 4： KS P ISO 110404 :2009 2009 12 7 http:/www.kats.go.krKS P ISO 110404:2009 : ( ) ( ) () () ( ) : (http:/www.standard.go.kr) ： ： 2004 12 18 ： 2009 12 7 2009-0762 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 110404:2009 i .1 1

2、 1 2 1 3 .2 3.1 . 2 3.2 .2 4 3 4.1 .3 4.2 .3 4.3 .3 5 4 A() .5 B() .7 KS P ISO 110404:2009 4： Prefilled syringesPart 4：Glass barrels for injectables 2007 2 ISO 110404, Prefilled syringesPart 4：Glass barrels for injectables , . KS P ISO 11040 . 1： 2： 3： 4： 5： 1 - (single-chamber design) , . , . 2 . .

3、 ( ) . KS P ISO 110405, 5： ISO 5941, Conical fittings with a 6 %(Luer) taper for syringes, needles and certain other medical equipmentPart 1：General requirements ISO 5942, Conical fittings with 6 %(Luer) taper for syringes, needles and certain other medical equipmentPart 2：Lock fittings ISO 720：1985

4、, GlassHydrolytic resistance of glass grains at 121 Method of test and classification ISO 48021：1988, GlasswareHydrolytic resistance of the interior surfaces of glass containersPart 1：Determination by titration method and classification ISO 48022：1988, GlasswareHydrolytic resistance of the interior

5、surfaces of glass containersPart 2：Determination by flame spectrometry and classification KS P ISO 110404:2009 2 3 3.1 1 1 A B . 3.2 . “ ”, , (mL), “lg” 1 KS P ISO 110404 (cl) 6 % (A ) 1 mL (lg) . KS P ISO 1104041lgAcl 2 KS P ISO 110404 (br) 6 % -(Luer- lock) (B ) 2 mL . KS P ISO 1104042Bbr 3 KS P I

6、SO 110404 (cl) (C ) 0.5 mL . KS P ISO 1104040.5Ccl a X ： A.1, A.2, A.3 . 1 d 1 lh 1 d 2 s 1 d 4 d 5 d 3 d 3 l 1 X a A B KS P ISO 110404:2009 3 1 ：mm d 1d 2d 5l 1s 1h 1d 3d 4 mL 0.5 6.85 4.65 4.40 47.6 1.11.8 13.4 10.5 1 a8.15 6.35 0.1 6.05 54 0.9 1.9 0.5 13.8 0.4 11 0.4 1 b10.85 8.65 8.25 35.7 1.1 2

7、.2 17.75 14.7 2 10.85 8.65 8.25 49 1.1 2.2 17.75 14.7 2.25 10.85 8.65 8.25 54.4 1.1 2.2 17.75 14.7 3 10.85 8.65 8.25 72.2 0.5 1.1 2.2 17.75 0.75 14.7 5 14.45 0.1 11.85 11.4566.7 1.32.4 0.5 23 19.5 10 17.05 14.25 13.8587.25 1.42.5 27 21.5 0.5 20 22.05 0.2 19.05 0.2 18.40 96.8 0.75 1.5 3.1 0.6 32.25 1

8、 25.9 0.6 a . b , 4 4.1 , . 4.2 4.2.1 ISO 720 HGA 1 (cl) (br) . I . 4.2.2 9 . 4.3 4.3.1 ISO 48021 ISO 48022 ISO 4802 HC 1(ISO 48021/2:1988) I . . 4.3.2 , mm 40 nm . KS P ISO 110404:2009 4 . 5 , , . . KS P ISO 110404:2009 5 A () ：mm a . b ISO 5941 A.1 A ：ISO 5941 6 % (Luer cone) ：mm a . b 0.03 mm, c

9、ISO 5942 A.2 B ：ISO 5942 (Luer-lock) 6 % (Luer cone) KS P ISO 110404:2009 6 X . A.3 C ：staked-needle KS P ISO 110404:2009 7 B () B.1 l mL 0.5 57.5 0.5 1 a64.0 0.5 1 b46.7 0.5 2 60.0 0.5 2.25 66.6 0.75 3 84.4 1.0 5 80.0 0.75 10 100.5 1.0 20 114.9 1.0 a . b , 4： 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO 110404 :2009 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Prefilled syringes Part 4 ：Glass barrels for injectables ICS 11.040.25 Korean Agency for Technology and Standards http:/www.kats.go.kr