GOST ISO 10993-5-2011 Medical devices Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity《医疗器械 医疗器械的生物学评价 第5部分 体外细胞毒性试验》.pdf

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GOST ISO 10993-5-2011 Medical devices Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity《医疗器械 医疗器械的生物学评价 第5部分 体外细胞毒性试验》.pdf_第1页
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GOST ISO 10993-5-2011 Medical devices Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity《医疗器械 医疗器械的生物学评价 第5部分 体外细胞毒性试验》.pdf_第2页
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GOST ISO 10993-5-2011 Medical devices Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity《医疗器械 医疗器械的生物学评价 第5部分 体外细胞毒性试验》.pdf_第3页
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GOST ISO 10993-5-2011 Medical devices Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity《医疗器械 医疗器械的生物学评价 第5部分 体外细胞毒性试验》.pdf_第4页
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GOST ISO 10993-5-2011 Medical devices Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity《医疗器械 医疗器械的生物学评价 第5部分 体外细胞毒性试验》.pdf_第5页
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1、 5 : in vitro(ISO 10993-5:1999, IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC) ISO10993-52011, 1.092 . 1.22009 . , - . , , -, 1 - ()2 3 , (- 29 2011 . 40) : ( 3166) 00497 ( 3166) 00497 BYKZKGRUTJUZ 4 13 2011 . 1308- ISO 10993-52011 1 2013 .5 ISO 10993-5:1999 Biolog

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4、es. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity1 in vitro. :) ();b) . in vitro - .2 , - , .ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing ( - . 1. )ISO 10993-12:1996 Biological evaluation of medical devices Part 12: Sample pr

5、eparation andreference materials ( . 12. )3 ISO10993-1,- :3.1 : , , , . , , 1) , .3.2 : , , , , -.1) (Rockville, Maryland, USA) FDA, (Ochiai 729-5, Hadanoshi, Kanagawa 257 Japan). ISO.1 ISO 10993-52011 20130101 - -. , ()1) , .3.3 : , . ISO 10993-12, 3.1.3.4 : , , , , . , .3.5 : 80 % , . . .4 4.1 :)

6、)b) . , - . ISO 10993-12.4.2 4.2.1 , , , -,- , . , , -, , , - , , , , , , , .4.2.2 - :) ;b) ;c) ;d) . . , -, . , - (). - , 0,5 % .1) () - SIMS Portex Ltd, Hythe, Kent, CT21 6JL, UK, ( 499-300-000). ZDEC ZDBC FDA, (Ochiai 729-5, Hadanoshi, Kanagawa 257 Japan). ISO.2 ISO 10993-520114.2.3 4.2.3.1 , - ISO 10993-12.4.2.3.2 :) 24 (37 c1772) ;b) (72 c1772) (50 c1772) ;c) (24 c1772) (70 c1772) ;d) (1 c1770,2) (121 c1772) . . , 4.2.3.2, a).4.2.3.3 ( ) , - - , - 9. . , , , .4.3

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