1、 . 3 , (ISO 10993-3:2003, IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)ISO 10993-32011, 1.092 . 1.22009 . , - . , , -, 1 - ()2 3 , (- 29 2011 . 40) : ( 3166) 00497 ( 3166) 00497 BYKZKGRUTJUZ 4 13 2011 . 1316- ISO 10993-32011 1 2013 .5 ISO 10993-3:2003 Biologicalev
2、aluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (- . 3. , - ). - . (IDT). 10993-320096 ( ) - . - , - . - , 2013 -, II ISO 10993-320111 12 13 24 24.1 .24.2 .34.3 34.4 34.4.1 in vitro 34.4.2 in vivo.45 45.1 .45.2 .45.3 45.4 46 56.1 .56.2 .56.3 56.4
3、 57 6 () 7 B () 8 C () .9 () 11 12III ISO 10993-32011 . . - , , , , . 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 -.IV ISO 10993-32011 . 3 , Medical devices. Biological evaluation of medical devices.Par
4、t 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity 201301011 :- ;- ;- . , -, -. ISO 10993-1. -.2 :ISO 10993-1:1997* . 1. -ISO 10993-2:1992* . 2. - ISO 10993-6:1994* . 6. - ISO 10993-12:2002* . 12. - ISO 10993-18 . 18. - OECD* 414 OECD 415 OECD 416 OECD 421 OECD 451 * ISO 10993-1:
5、2003, ISO 10993-2:2006, ISO 10993-6:2007, ISO 10993-12:2007 .* .1 ISO 10993-32011 OECD 453 /OECD 471 OECD 473 in vitroOECD 476 in vitro3 ISO 10993-1, 10993-12, - :3.1 ( ): , , / - - . , . , , . , / , (. . ).3.2 , : , , - . , , -, .3.3 : , -, , , , . .3.4 (): , .3.5 : , , (), .4 4.1 ISO 10993-1, (ISO
6、 10993-18). -.ISO 10993-1 , - (. ISO 10993-1:1997, 1). - , , , , -. , - , , -. - , . , , in vitro. , 2(4.2.1.2), -2 ISO 10993-32011, , 1 (4.2.1.1). -, , .4.2 4.2.1 1 (4.2.1.1), 2 (4.2.1.2).4.2.1.1 1) (OECD 471) b) (OECD 476) c) (OECD 473).4.2.1.2 2) (OECD 471) b) (OECD 476), ( ).4.2.2 in vitro, 4.2.1, . in vivo ISO 10993-2.4.2.3 in vitro in vivo - (. 4.2.4) , .4.2.4 in vivo , - in vitro. , -. , in vivo - - in vivo. in vivo:) (CD 474) b) (CD 475) c) (CD 486). -.4.2.5 in vivo - , -.4.3 4.3.1 , ISO 10993-12. -,
