KS P ISO 8871-4-2010 Elastomeric parts for parenterals and for devices for pharmaceutical use－Part 4：Biological requirements and test methods《非肠道及制药设备用弹性件 第4部分 生物学要求和试验方法》.pdf

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

2、 2 4.1 .2 4.2 .2 4.3 2 4.4 .2 A( ) .4 A.1 .4 A.2 .4 A.3 4 A.4 .4 A.5 4 A.6 5 B( ) .6 B.1 .6 B.2 6 B.3 .6 B.4 6 C( ) 7 C.1 .7 C.2 7 C.3 .7 C.4 7 D( ) .8 D.1 .8 D.2 8 D.3 .8 D.4 8 9 KS P ISO 8871 4:2010 ii . , , . , , . KS P ISO 8871 4:2010 iii 2006 1 ISO 8871 4, Elastomeric parts for parenterals and

3、for devices for pharmaceutical use Part 4： Biological requirements and test methods . . A D . . A D . KS P ISO 8871 4:2010 4： Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4： Biological requirements and test methods 1 . , . 2 . . ( ) . KS P ISO 10993 5, 5： USP, The Un

4、ited States Pharmacopeia, United States Pharmacopeial Convention, Inc., Rockville, MD, USA 3 . 3.1 (bacterial endotoxins) - (lipo-polysaccharides) 3.2 (bioburden) / KS P ISO 11737 1, 3.1 3.3 (cytotoxicity) KS P ISO 8871 4:2010 2 3.4 (intracutaneous toxicity) 3.5 (systemic toxicity) 4 4.1 . , , , . ,

5、 , . . 4.2 (EU/cm2) (EU/mL) . . A . 4.3 (cfu/cm2) cfu . . KS P ISO 11737 1 . 4.4 4.4.1 4.4.2 . . 4.4.3 4.4.4 . KS P ISO 8871 4:2010 3 4.4.2 B . USP “ , ” . 4.4.3 C . USP “ , ” . 4.4.4 D . USP . KS P ISO 8871 4:2010 4 A ( ) A.1 . USP “ ” Ph.Eur.2 2.6.14 “ ” . A.2 (endotoxin-free water) . USP Ph.Eur L

6、imulus polyphemus LAL LAL(limulus amebocyte lysate) . A.3 A.3.1 / (： ) A.3.2 (endotoxin-free water) A.3.3 USP Ph.Eur. A.4 A.4.1 . . A.4.2 . A.4.3 (： 250 30 ) . A.4.4 . A.5 (10010) cm2 . 100 mL 5 ( ). (10010) cm2 , (10.1) mL . KS P ISO 8871 4:2010 5 , 13 mm , , . . A.6 EU/cm2 EU/mL . KS P ISO 8871 4:

7、2010 6 B ( ) B.1 . USP KS P ISO 10993 5 . B.2 USP KS P ISO 10993 5 . (371) 24 20 mL 25 cm2 / . B.3 USP KS P ISO 10993 5 . B.4 B.4.1 . B.4.2 . 50 % . (cell lysis) . KS P ISO 8871 4:2010 7 C ( ) C.1 . USP . C.2 USP 9 g/L NaCl . C.3 USP . C.4 C.4.1 . C.4.2 USP . KS P ISO 8871 4:2010 8 D ( ) D.1 . USP .

8、 D.2 USP . D.3 USP . D.4 D.4.1 . D.4.2 USP . KS P ISO 8871 4:2010 9 1 KS P ISO 11737 1, 1： 2 Ph.Eur., European Pharmacopeia, European Directorate for the Quality of Medicines, Council of Europe, Strasbourg, France 4： 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 4:2010KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Elastomeric parts for parenterals and for devices for pharmaceutical usePart 4： Biological requirements and test methods ICS 11.040.20