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GOST ISO 10993-1-2011 Medical devices Biological evaluation of medical devices Part 1 Evaluation and testing《医疗器械 医疗器械的生物学评价 第1部分 评价与测试》.pdf

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1、 . 1 (ISO 10993-1:2003, IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC) ISO10993-12011, 1.092 . 1.22009 . , - . , , -, 1 - ()2 3 , ( 29 2011 . 40) : ( 3166) 00497 ( 3166) 00497 BYKZKGRUTJUZ 4 13 2011 . 1315- ISO 10993-12011 1 2013 .5 ISO 10993-1:2003 Biologicalevalu

2、ation of medical devices Part 1: Evaluation and testing ( - . 1. ). (IDT). 10993-120096 -, - . () . , - - C, 2014 -, II ISO 10993-120111 .12 13 .24 35 .46 .67 .9 () .10 () - 1213III ISO 10993-12011 ISO 10993 - - . - - . , -, . ISO 10993 - , - , . ISO 10993, - . , , . ISO 10993 . : 1 ; 2 ; 3 , - ; 4

3、, ; 5 : in vitro; 6 ; 7 ; 9 ; 11 ; 12 ; 13 ; 14 ; 15 ; 16 -; 17 ; 18 ; 19 -, ; 20 .IV ISO 10993-12011 . 1 Medicaldevices.Biologicalevaluationofmedicaldevices.Part1.Evaluationandtesting1 :- ( );- -;- .,-,.-, , -(,.). (.-).2 :2.1 : ,-, , , -:- ,;- , , , ;- ,;- ,.1 . ,.2 .1 ISO 10993-12011 201301012.2

4、: , , , - , , .2.3 : , - .3 3.1 , - , . - , . , - , . , - , - .3.2 , , , , -, .3.3 :) ;b) , ;c) ;d) ;e) ;f) . , - - ISO 10993-9.3.4 , , , , - . , - (. 4). / . :- (: , , , , , );- (: - , , , , ).3.5 -.,- (. 6).3.6 in vitro in vivo , - , - . , in vitro in vivo. , , (.3.6.2).2 ISO 10993-120113.7 :- , ;- , , ;- ;- , , - .3.8 , , , , , - (. 3.8 .2 - ).4 4.1 , 3, , ., . , , , - . - , 4.2 4.3.4.2 4.2.1 , , , .4.2.2 , , :) . , , , , , ;b) . , -,- ( , , , ), , , , ;c) . - , , , , , .4.2.3 , , :) , . , - , , - ;b) ,

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