KS P ISO 595-2-2008 Reusable all-glass or metal-and-glass syringes for medical use－Part 2：Design performance requirements and tests《可重复使用的全玻璃或金属 玻璃医用注射器 第2部分 设计、性能要求和试验》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 595 2 2： , KS P ISO 595 2:2008 2008 11 7 http:/www.kats.go.krKS P ISO 595 2:2008 : ( ) ( ) ( ) ( ) : (http:/www.standard.go.kr) ： ： 2003 4 30 ： 2008 11 7 2008-0746 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 595 2:2008 i ii .1 1 1 2

2、 1 3 1 3.1 .1 3.2 .1 4 .2 4.1 2 4.2 2 4.3 3 5 .3 5.1 3 5.2 .3 5.3 3 5.4 3 5.5 .3 5.6 3 5.7 .3 6 4 6.1 .4 6.2 4 6.3 .4 6.4 .4 6.5 4 6.6 .4 6.7 5 KS P ISO 595 2:2008 ii . KS P ISO 595 2： 2003 . . , , . , , . KS P ISO 595 2:2008 2： , Reusable all-glass or metal-and-glass syringes for medical usePart 2：

3、 Design, performance requirements and tests 1987 1 ISO 595 2, Reusable all-glass or metal-and-glass syringes for medical use Part 2： Design, performance requirements and tests . 1 1100 mL , . . 2 . . ( ) . ISO 594 1, Conical fittings with a 6 %(Luer) taper for syringes, needles and certain other med

4、ical equipment Part 1： General requirements ISO 594 2, Conical fittings with a 6 %(Luer) taper for syringes, needles and certain other medical equipment Part 2： Lock fittings 3 3.1 . 3.2 , 6.3KS P ISO 595 2:2008 2 . 4 4.1 4.1.1 . 4.1.2 ISO 594 1 / ISO 594 2 6 %(Luer) (male) . 4.1.3 2 mL , 2 mL . 4 m

5、m , . 4.1.4 . 4.1.5 . 4.1.6 . , , . . 4.2 4.2.1 , , . . 4.2.2 . 4.2.3 , . 10 , . 4.2.4 . . 1 . 2 . KS P ISO 595 2:2008 3 4.2.5 . 4.2.6 6.6 . 4.3 4.3.1 , , , , . 4.3.2 , , . 4.3.3 . 4.3.4 10 , . 5 5.1 6.1 . 5.2 6.2 , . 5.3 6.3 , . 5.4 6.4 . 5.5 6.5 . 5.6 6.6 . 5.7 KS P ISO 595 2:2008 4 6.7 . 6 6.1 (9

6、91) . 30 , (991) , . 6.2 . 180 30 , , . 6.3 . a) (1215) 30 . b) (991) 30 . c) 9 g (991) 30 . , . 6.4 ISO 594 (female) , . a) 110 mL 300 kPa b) 10 mL 30 mL 200 kPa c) 30 mL 150 kPa 10 . 6.5 c(HCl) 0.01 mol/L 30 (1215) 30 . 30 . 6.6 . 50 KS P ISO 595 2:2008 5 a) 110 mL 300 kPa b) 10 mL 30 mL 200 kPa c

7、) 30 mL 150 kPa . . 6.7 . 2： , 135513 7017 (02)60094114 (02)600948878 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 595 2:2008 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Reusable all-glass or metal-and- glass syringes for medical use Part 2：Design, performance requirements and tests ICS 11.040.20