KS P ISO 10993-20-2009 Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices《医疗设备的生物学评估 第20部分 医疗设备的免疫毒物学试验的原则和方法》.pdf

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2、09 i ii 1 1 2 1 3 .1 4 .2 5 2 6 4 6.1 .4 6.2 .5 6.3 .5 6.4 .6 6.5 .7 6.6 .7 7 .7 A( ) 8 B( ) .12 C( ) 13 14 KS P ISO 10993 20:2009 ii 2006 1 ISO/TS 10993 20, Biological evaluation of medical devices Part 20： Principles and methods for immunotoxicology testing of medical devices . . . , , . , , . KS

3、P ISO 10993 20:2009 20： Biological evaluation of medical devices Part 20： Principles and methods for immunotoxicology testing of medical devices 1 . (type) . . A . B . 11 . 2 . . ( ) . KS P ISO 10993 1, 1： KS P ISO 10993 6, 6： KS P ISO 10993 10, 10： KS P ISO 10993 11, 11： ISO 10993 2： 2006, Biologic

4、al evaluation of medical devices Part 2： Animal walfare requirements ISO 14971： 2007, Medical devices Application of risk management to medical devices 3 . KS P ISO 10993 20:2009 2 3.1 (xenobiotics) . 3.2 , , , , , , , , , , , , , . 1 , . 2 “ ” . 3.3 (xenobiotic) 3.4 (immunogenic) 4 , . . . , ISO 14

5、971 . . (chlorohexidine) . / . , , , . 5 ( ) . , . KS P ISO 10993 20:2009 3 , . . (type) 1 . 1 A： ( 24 ) B： ( 24 30 )C： ( 30 ) / A B C A B C A B C A B C A B , , C A B , C (type) , . ( ). . . , , , . KS P ISO 10993 20:2009 4 , (hapten) . , , . , , , , . 1 000 000 (daltons) , . . . ： KS P ISO 10993 1

6、( ) . I IV , I IV . ： . 24 . 6 6.1 . . , . (mechanistic studies) . . , ISO 10993 2 , . . , , , . . , . , / . , , ( , ) / . “ (-omics)” . C . KS P ISO 10993 20:2009 5 2 . , . (sub-acute test) . KS P ISO 10993 11 . 6.2 , (type) . , . . / . KS P ISO 10993 6 . C . 6.3 . 1 2 . . 1 , 2 . 1 , / , . 2 NK /

7、( , ) , . 1 ( T ). , / / . (type) . . , . . OECD 4071 , KS P ISO 10993 20:2009 6 . 2 a / / KS P ISO 10993 6 KS P ISO 10993 11 . b ( , ELISA) (C3a C5a ) , , , T (Th1, Th2) ( T ) . (IL1, TNF, IL6, TGF, IL10, - ) MHC T . T NK ( , , ) , , , . , . . . . . , , , , , a . / . b . . 6.4 , KS P ISO 10993 20:2

8、009 7 . . . . . KS P ISO 10993 11 F . 6.5 . . (IV ) (I ) . I . . KS P ISO 10993 10 . IgE . IgE . . 6.6 . . . . , . . T T ( ) . . 7 , / . . ( , , , ) ( , , , ) , . , . KS P ISO 10993 20:2009 8 A ( ) A.1 , . , , . . , . ( , , ) , / , T , . ( , ), . , . , ( , ) . B B , B . B . B . . , (HLA) B . T HLA .

9、 B T . T . , . , , . . a) , b) T , . . (Ig) B . T T ( ) T (type) . KS P ISO 10993 20:2009 9 A.2 . “ ”( “ ” ) ( , ), ( ) ( , ) . / . . a) b) c) (anti-self response) / , ( , , ) , . , - (Epstein-Barr virus) B UV-B . , . . , (hydralizine) , . . , . , ( ) . , ( , , ), . , . T . . , . ( ) , (種 ) . KS P ISO 10993 20:2009 10 ,