GOST ISO 10993-18-2011 Medical devices Biological evaluation of medical devices Part 18 Chemical characterization of materials《医疗器械 医疗器械的生物学评价 第18部分 材料的化学特征》.pdf

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GOST ISO 10993-18-2011 Medical devices Biological evaluation of medical devices Part 18 Chemical characterization of materials《医疗器械 医疗器械的生物学评价 第18部分 材料的化学特征》.pdf_第1页
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GOST ISO 10993-18-2011 Medical devices Biological evaluation of medical devices Part 18 Chemical characterization of materials《医疗器械 医疗器械的生物学评价 第18部分 材料的化学特征》.pdf_第2页
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GOST ISO 10993-18-2011 Medical devices Biological evaluation of medical devices Part 18 Chemical characterization of materials《医疗器械 医疗器械的生物学评价 第18部分 材料的化学特征》.pdf_第3页
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GOST ISO 10993-18-2011 Medical devices Biological evaluation of medical devices Part 18 Chemical characterization of materials《医疗器械 医疗器械的生物学评价 第18部分 材料的化学特征》.pdf_第4页
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GOST ISO 10993-18-2011 Medical devices Biological evaluation of medical devices Part 18 Chemical characterization of materials《医疗器械 医疗器械的生物学评价 第18部分 材料的化学特征》.pdf_第5页
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1、 . 18 (ISO 10993-18:2005, IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)ISO 10993-182011, 1.092 . 1.22009 . , - . , , -, 1 - ()2 3 , (- 29 2011 . 40) : ( 3166) 00497 ( 3166) 00497 BYKZKGRUUZTJ 4 13 2011 . 1313- ISO 10993-182011 - 1 2013 .5 ISO 10993-18:2005 Biologi

2、calevaluation of medical devices Part 18: Chemical characterization of materials ( . 18. ). - . (IDT). 10993-1820096 - , - . () - . , , 2014 -, II ISO 10993-1820111 12 13 24 25 36 46.1 .46.2 1 .46.3 2 56.4 3 56.5 4 .56.6 5 , 57 57.1 .57.2 .57.3 .67.4 .77.5 78 8 A () -, , .9 B () .10 C () .12 () 13 1

3、3III ISO 10993-182011 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 10993-1 . 3 ISO 10993-1:2003 , . , , , -, , . . 7.2 ISO 10993-1:2003 , - . ISO 14971 , ., , -, :- , ,

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5、13, ISO 10993-14 ISO 10993-15. ISO 10993 , - (. 4.2.1 ISO 10993-1:2003). - .2 . . , .IS 10993-1:2003 Biological evaluation of medical devices Part 1: Evaluation and testing ( . 1. )IS 10993-17 Biological evaluation of medical devices Part 17: Establishment of allowable limits forleachable substance

6、s ( . 17. )IS 14971:2000 Medical devices. Application of risk management to medical devices ( -. )1 ISO 10993-182011 3 ISO 10993-1, - :3.1 : , / - .3.2 : , , , , , - .3.3 : , , - , .3.4 : , (, , , - ).3.5 : , - , .3.6 : , - 10 % , . , , -, , . . - T . T , T. - . . - . - . , :) , , , ;b) , ;c) , - .3.7 : , , . . 3.6.4 7 . 1 - - 2 ISO 10993-182011 1 -a - () () () a- , -,- -.5

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