GOST ISO TS 10993-19-2011 Medical devices Biological evaluation of medical devices Part 19 Tests physico-chemical morphological and topographical characterization of materials《医疗器械.pdf

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1、 . 19 -, (ISO/S 10993-19:2006, IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC) ISO/TS10993-192011, 1.092 . 1.22009 . , - . , , -, 1 - ()2 3 , (- 29 2011 . 40) : ( 3166) 00497 ( 3166) 00497 BYKZKGRUTJUZ 4 13 2011 . 1311- ISO 10993-192011 - 1 2013 .5 ISO/S 10993-19:20

2、06 Biologicalevaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterizationof materials ( . 19. -, ). - 1.52001 ( 3.6). - . (IDT). / 10993-1920096 ( ) - . , - . - C, 2013 -, II ISO/TS 10993-1920111 .12 13 24 .25 .36 .56.1 56.2 66.3 .66.4 76.5 77 .78 .12A()

3、13B() .- 14() .1617III ISO/TS 10993-192011 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 -.ISO 14971 , - .ISO 10993-1 .ISO 10993-1, 3, , , , -. , , -, , , . .ISO10993-1,7.2 , - . -,

4、-, , - , . :- (ISO 10993);- / , - . , , . , , , , , -.IV ISO/TS 10993-192011 IS/S 10993-192011 1 19 -, Medical devices. Biological evaluation of medical devices. Part 19. Physico-chemical, morphological and topographical characterization of materials 20130101 1 , -, () , . , ( , ), . 2 , . . ISO 109

5、93-1 Biological evaluation of medical devices Part 1: Evaluation and testing ( . 1. ) IS/S 10993-192011 2 ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials ( . 18. ) 3 ISO 10993-1, ISO 10993-18, : 3.1 -: (). 3.2 : , (). 3.3 : (). 4 : - ; - -,

6、. , 1, 7. IS/S 10993-192011 3 1 , / - / , -, - - - -, , - - () ( ) / / / -/ - / / 5 IS/S 10993-192011 4 , , ( ISO 10993-18), . : ) , b) . , , . , . . 1 , , . 2 , (Dexter et al. 50). 3 , , , , , . 4 , , (Alaerts et al. 46, Dewez et al. 49). 5 , , , . . , , , . . IS/S 10993-192011 5 , , . , . , . , , , , , , , , . , , , . 6 6.1 , . , ,

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