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

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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 : - ; - -,

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