GOST ISO 10993-10-2011 Medical devices Biological evaluation of medical devices Part 10 Tests for irritation and delayed-type hypersensitivity《医疗器械 医疗器械的生物学评价 第10部分 刺激与持续型过敏症试验》.pdf

1、 , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC)ISO 10993-102011 10 (ISO 10993-10:2002, IDT) ISO 10993-102011II, 1.092 . 1.22009 . , - . , , -, 1 - ()2 3 , (- 29 2011 . 40) : ( 3166) 00497 ( 3166) 00497 BY KZ KG RU TJ 4 13 2011 . 1347- ISO 10993-102011 - 1 2013 .5 ISO 1

2、0993-10:2002 Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity ( - . 10. - ). - . (IDT). 10993-1020096 - , . () - . , - , 2014 -, - ISO 10993-102011III1 .12 13 24 .35 35.1 .35.2 .35.3 45.4 46 46.1 in vitro .46.2 , in vitro 56.3 .56.4 .87 .127.1

3、.127.2 127.3 , .127.4 137.5 158 17 () 18 B () .19 C () 32 () 35 37 ISO 10993-102011IV ISO 10993 - . - - . - , -, - . ISO 10993 - , - , . ISO 10993 - : 1 ; 2 ; 3 , - ; 4 , ; 5 : in vitro; 6 ; 7 ; 9 ; 10 ; 11 ; 12 ; 13 ; 14 ; 15 ; 16 ; 17 ; 18 ; 19 -, -; 20 . , BS 5736, OECD, . - , - , - .1 201301011

4、- , . :) ;b) ;c) , . . ISO 10993-1. - . B , , , , , .2 -:ISO 10993-1:1997* Biological evaluation of medical devices Part 1: Evaluation and testing ( . 1. )ISO 10993-2 Biological evaluation of medical devices Part 2: Animal welfare requirements ( . 2. )ISO 10993-9 Biological evaluation of medical dev

5、ices Part 9: Framework for identification and quantification of potential degradation products ( . 9. - )ISO 10993-12 Biological evaluation of medical devices Part 12: Sample preparation and reference materials ( . 12. )ISO 10993-13 Biological evaluation of medical devices Part 13: Identification an

6、d quantification of degradation products from polymeric medical devices ( -. 13. )* ISO 10993-1:2003. ISO 10993-102011 10 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity ISO 10993-1020112ISO 10993-14 Biological evaluation of

7、medical devices Part 14. Identification and quantification of degradation products from ceramics ( . 14. )ISO 10993-15 Biological evaluation of medical devices Part 15. Identification and quantification of degradation products from metals and alloys ( . 15. )ISO 10993-18 Biological evaluation of med

8、ical devices Part 18. Chemical characterization of ma-terials ( . 18. )ISO 14555-1 Clinical investigation of medical devices for human subjects Part 1: General requirements ( . 1. )ISO 14555-2 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans ( . 2. )3

9、 ISO 10993-1, - :3.1 : , - , .3.2 : , , , , .3.3 : , , .3.4 : (, - ).3.5 : - , , .3.6 : , - .3.7 : .3.8 : .3.9 : , de novo - .3.10 : , .3.11 : , - /.3.12 : , , - .3.13 : , , -, -.3.14 : .3.15 : , , - -.3.16 : , , , -, (, -, , . .).3.17 : , , , - .3.18 : , .3.19 : , . ISO 10993-10201134 -. , :) , - ISO 10993-9; ISO 10993-13; ISO 10993-14; ISO 10993-15 ISO 10993-18;b) , , ;c) in vitro in vivo , in vitro