KS P ISO 8871-5-2010 Elastomeric parts for parenterals and for devices for pharmaceutical use－Part 5：Functional requirements and testing《非肠道及制药设备用弹性件 第5部分 功能要求和试验》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 8871 5 5： KS P ISO 8871 5:2010 2010 12 30 http:/www.kats.go.krKS P ISO 8871 5:2010 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2010 12 30 2010-0689 ： ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO 8871 5:2010 i ii iii 1 1 2 1 3 .1 4

2、 2 4.1 .2 4.2 .2 4.3 2 4.4 2 5 2 5.1 .2 5.2 .2 5.3 .3 A( ) .4 A.1 .4 A.2 .4 A.3 , 4 A.4 .4 A.5 4 B( ) .5 B.1 .5 B.2 .5 B.3 , 5 B.4 .5 B.5 6 C( ) .7 C.1 .7 C.2 .7 C.3 , 7 C.4 .7 C.5 8 D( ) .9 D.1 .9 D.2 .9 D.3 , 9 D.4 .9 D.5 10 11 KS P ISO 8871 5:2010 ii . , , . , , . KS P ISO 8871 5:2010 iii 2005 1

3、ISO 8871 5, Elastomeric parts for parenterals and for devices for pharmaceutical use Part 5： Functional requirements and testing . . , , . . . KS P ISO 8871 5:2010 5： Elastomeric parts for parenterals and for devices for pharmaceutical use Part 5： Functional requirements and testing 1 . KS P ISO 853

4、6 2 KS P ISO 8536 6 . 2 . . ( ) . KS P ISO 8362 1, 1： KS P ISO 8362 3, 3： KS P ISO 8362 4, 4： KS P ISO 8362 6, 6： ISO 7864, Sterile hypodermic needles for single use 3 . 3.1 (penetrability) 3.2 (fragmentation) 3.3 (self-sealing) KS P ISO 8871 5:2010 2 3.4 (container closure seal integrity) / 4 4.1 A

5、 10 N . 4.2 B 48 5 . 4.3 C . , . 4.4 . 4.4 D . 5 5.1 . 10 12 10 10 . 5.2 . . 5 5 . KS P ISO 8871 5:2010 3 5.3 . (borosilicate) , . 20 30 (1212) 30 . . . , (ethylene oxide) . . KS P ISO 8871 5:2010 4 A ( ) A.1 . . A.2 . A.3 , A.3.1 10 , 5. A.3.2 10 , KS P ISO 8362 1 KS P ISO 8362 4 ( 13 mm, 20 mm) A.

6、3.3 / 10 , KS P ISO 8362 3 KS P ISO 8362 6 ( 13 mm, 20 mm) A.3.4 ( 112) 10 , ISO 7864 0.8 mm A.3.5 , 0.25 N 10 N A.4 A.4.1 . A.4.2 (A.3.5) (A.3.4) . . 9 . A.5 4.1 . KS P ISO 8871 5:2010 5 B ( ) B.1 . , . B.2 . . B.3 , B.3.1 12 , 5. B.3.2 12 , KS P ISO 8362 1 KS P ISO 8362 4 ( 13 mm, 20 mm) B.3.3 / 1

7、2 , KS P ISO 8362 3 KS P ISO 83626 ( 13 mm, 20 mm) B.3.4 , B.3.5 ( 112) 12 , ISO 7864 0.8 mm B.3.6 , B.3.5 B.3.7 , 0.5 m B.3.8 , 0.5 m B.3.9 , 6X B.4 B.4.1 12 4 mL ( 25 mL 21 mL ). . B.4.2 (B.3.5) 1 mL 1 mL . KS P ISO 8871 5:2010 6 . . B.4.3 12 0.5 m . 50 m . . B.5 4.2 . KS P ISO 8871 5:2010 7 C ( )

8、 C.1 . . . , . . . / . C.2 . C.3 , C.3.1 10 , 5. C.3.2 10 , KS P ISO 8362 1 KS P ISO 8362 4 ( 13 mm, 20 mm) C.3.3 / 10 , KS P ISO 8362 3 KS P ISO 83626 ( 13 mm, 20 mm) C.3.4 , C.3.5 (methylene blue) , 1 g/L C.3.6 ( 112) 10 , ISO 7864 0.8 mm C.3.7 , 10 27 kPa C.4 C.4.1 10 ( 25 mL 25 mL ). . KS P ISO

9、8871 5:2010 8 C.4.2 10 , . . . 27 kPa . 10 . 30 . . C.5 4.3 . KS P ISO 8871 5:2010 9 D ( ) D.1 . . / , . D.2 . / . . D.3 , D.3.1 10 , 5. D.3.2 10 , KS P ISO 8362 1 KS P ISO 8362 4 ( 13 mm, 20 mm) D.3.3 / 10 , KS P ISO 8362 3 KS P ISO 83626 ( 13 mm, 20 mm) D.3.4 , D.3.5 (methylene blue) , 1 g/L D.3.6

10、 , 10 27 kPa D.4 D.4.1 10 ( 25 mL 25 mL ). . D.4.2 . . 27 kPa . 10 . 30 . KS P ISO 8871 5:2010 10 . D.5 4.4 . KS P ISO 8871 5:2010 11 1 KS P ISO 8536 2, 2： 2 KS P ISO 8536 6, 6： 5： 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 8871 5:2010KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Elastomeric parts for parenterals and for devices for pharmaceutical use Part 5： Functional requirements and testing ICS 11.040.20