1、 , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC)ISO 10993-112011 . 11 (ISO 10993-11:2006, IDT) ISO 10993-112011II, 1.092 . 1.22009 . , - . , , -, 1 - ()2 3 , (- 29 2011 . 40) : ( 3166) 00497 ( 3166) 00497 BY KZ KG RU TJ UZ 4 13 - 2011 . 1327- ISO 10993-112011 1 2013 .5
2、ISO 10993-11:2006 Biological evalu-ation of medical devices Part 11: Tests for systemic toxicity ( - . 11. ). - . (IDT). 10993-1120096 , 2014 -, - ISO 10993-112011III - , - . () - . , ISO 10993-112011IV1 1 2 .13 14 24.1 24.2 24.3 34.4 34.5 34.6 .44.7 .44.8 .44.9 / 54.10 54.11 64.12 64.13 64.14 .65 7
3、5.1 . 75.2 75.3 .85.4 96 (, .106.1 106.2 106.3 .126.4 .12 A () .13 B () 15 C () .16 D () , 17 E () 18 F () , .19 () 20 21 ISO 10993-112011V 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
4、 -, -; 20 . . , , , , , () . , - - , , - . , - . , - , , . , - , . ISO 10993-112011VI , (, ) -, , , - , . -, , ISO 10993-3, ISO 10993-6, ISO 10993-10 ISO 10993-20. (. F) , - . , , . . - -.1 20130101 1 , - , . -. - , .2 : IS 10993-1 Biological evaluation of medical devices Part 1: Evaluation and test
5、ing ( - . 1. )IS 10993-2 Biological evaluation of medical devices Part 2: Animal welfare requirements ( . 2. )IS 10993-12 Biological evaluation of medical devices Part 12: Sample preparation and reference materials ( . 12. )3 ISO 10993-1, - :3.1 : (. , ), .3.2 -: - .3.3 -: , . . . .3.4 : , - , . ISO
6、 10993-112011 . 11 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity ISO 10993-1120112 , , , , , , , -, , , , .3.5 : , - .3.6 : , - . 6 12 .3.7 : , - 24 . 3.8 : , - 24 28 . , , . - 14 28 . 24 , 14 .3.9 : , ( 90 , 10 % ). 90 , 10 % .3.10 : , - . 6 12 .3.11 : , , , , -, .4 4.1 ISO 10993-1, . - / / . - . , . . , - , , , pH, , , -, , .
