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

《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》由会员分享，可在线阅读，更多相关《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（20页珍藏版）》请在麦多课文档分享上搜索。

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

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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 )-/- - - - - ,- , , - -, . () - ,