KS P ISO 13926-1-2010 Pen systems－Part 1：Glass cylinders for pen-injectors for medical use《针头系列 第1部分 医用注射器针头用玻璃圆柱体》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 13926 1 1： - KS P ISO 13926 1:2010 2010 12 17 http:/www.kats.go.krKS P ISO 13926 1:2010 : ( ) ( ) () () ( ) : (http:/www.standard.go.kr) ： ：2004 12 18 ：2010 12 17 2010-0598 ： ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO 13926 1:2010 i

2、ii 1 1 2 1 3 1 4 3 4.1 .3 4.2 .3 5 3 6 4 5 KS P ISO 13926 1:2010 ii 2004 3 ISO 13926 1, Pen systems Part 1： Glass cylinders for pen-injectors for medical use , . . KS P ISO 13926 1： 2004 . . , , . , , . KS P ISO 13926 1:2010 1： - Pen systems Part 1： Glass cylinders for pen-injectors for medical use

3、1 ISO 11608 1 - , , , . . 2 . . ( ) . ISO 720： 1985, Glass Hydrolytic resistance of glass grains at 121 Method of test and classification ISO 4802 1： 2010, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 1： Determination by titration method and classification ISO 48

4、02 2： 2010, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2： Determination by flame spectrometry and classification 3 1 1 . (d6) h1 . . (h1) 0.3 mm KS P ISO 13926 1:2010 2 a l1 l2 1 - a a KS P ISO 13926 1:2010 3 1 - ： mm d1tol. d2tol. d3d4tol. d5tol. d6tol. h1tol.

5、 h2tol. 8.65 0.1 6.85 0.1 6.55 7.15 0.2 5.6 0.35 3.15 0.2 5.0 0.20 2.9 0.110.85 0.1 8.65 0.1 8.35 7.15 0.2 5.6 0.35 3.15 0.2 5.0 0.20 2.9 0.110.95 0.15 9.25 0.1 8.95 7.15 0.2 5.6 0.35 3.15 0.2 5.0 0.20 2.9 0.111.60 0.15 9.65 0.1 9.35 7.15 0.2 5.6 0.35 3.15 0.2 5.0 0.20 2.9 0.114.00 0.15 12.00 0.15 1

6、1.65 9.5 0.2 7.6 0.35 4.5 0.2 5.0 0.50 2.9 0.1514.45 0.15 11.85 0.15 11.50 9.5 0.2 7.6 0.35 4.5 0.2 5.0 0.50 2.9 0.1518.25 0.15 16.05 0.15 15.50 9.5 0.2 7.6 0.35 4.5 0.2 5.0 0.50 2.9 0.154 4.1 ISO 720 HGA 1 (cl) (br) . 1 . 9 . . 4.2 4.2.1 , . 4.2.2 ISO 4802 1 ISO 4802 2 HC 1 . . 4.2.3 mm 40 nm . . 5

7、 KS P ISO 13926 1:2010 4 - , d1(mm) . ISO 4802 HC 1 (cl) d1 11.6 mm - . KS P ISO 13926 1 cl 11.6 6 . a) b) ( )( , , ) c) d) KS P ISO 13926 1:2010 5 1 KS P ISO 11040 3, 3： 2 ISO 11608 1： 2000, Pen-injectors for medical use Part 1： Pen-injectors Requirement and test methods 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 13926 1:2010KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Pen systems Part 1： Glass cylinders for pen-injectors for medical use ICS 11.040.25