GOST ISO TS 10993-20-2011 Medical devices Biological evaluation of medical devices Part 20 Principles and methods for immunotoxicology testing of medical devices《医疗器械 医疗器械的生物学评价 第2.pdf

1、 . 20 (ISO/S 10993-20:2006, IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)ISO/TS 10993-202011, 1.092 . 1.22009 . , - . , , -, 1 - ()2 3 , (- 29 2011 . 40) : ( 3166) 00497 ( 3166) 00497 BYKZKGRUUZTJ 4 13 2011 . 1312- ISO/S 10993-202011 - 1 2013 .5 ISO/S 10993-20:200

2、6 Biologicalevaluation of medical devices Part 20: Principles and methods for immuno-toxicology testing of medicaldevices ( . 20. - ). - . (IDT). / 10993-2020096 - , - . () - . , , 2014 -, II ISO/TS 10993-2020111 12 13 24 25 .26 46.1 .46.2 .56.3 .56.4 76.5 76.6 77 7 A () 8 B () .11 C () - 12 () .13

3、14III ISO/TS 10993-202011 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 . - . . . :- , ;- . , Medline, - , . :- ;- ;- ;- ;- . :- ;- ;- , ;- . . 1 .IV ISO/TS 10993-202011 . 20

4、Medical devices. Biological evaluation of medical devices.Part 20. Principles and methods for immunotoxicology testing of medical devices 201301011 - . - . , - , - . . - , , - B. . , 11.2 . . - , ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing ( - . 1. )ISO 10993-

5、2 Biological evaluation of medical devices Part 2: nimal welfare requirements ( . 2. )ISO 10993-6 Biological evaluation of medical devices Part 6: Tests for local effects after implantation( . 6. - )ISO 10993-10 Biological evaluation of medical devices Part 10: Tests for irritation and delayed-typeh

6、ypersensitivity ( . 10. - )ISO 10993-11 Biological evaluation of medical devices Part 11: Tests for systemic toxicity ( . 11. )ISO 14971 Medical devices. Application of risk management to medical devices ( -. )1 ISO/TS 10993-202011 3 :3.1 : , , , .3.2 : , , , -, , , - , , :- , , , ;- , , , - ;- , ;- , , .1 , . - , .2 .3.3 : , .3.4 : .4 , - , - . , . , - , . - ISO 14971. , , . - - . , , -, , , - .5 - . - . , :- ;- ;- ;- , ;- ;- , , -;- .2 ISO/TS 10993-202011 , , - . , - . 1 . 1 - - ( 24 )B ( 24 30 )C ( 30 )-/- - - - - ,- , , - -, . () - ,