1、 , () INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) 15 (ISO 10993-15:2000, IDT) 2013 ISO 10993-15 2011 ISO 10993-15 2011 II , 1.092 . 1.22009 . , . , , , 1 - () 2 () 3 , ( 40-2011 29 2011 .) : ( 3166) 00497 ( 3166) 00497 BY KZ KG RU TJ UZ 4 13 2011 . 1302- ISO 10993-15201
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4、als and alloys 20130101 1 , . , , in vitro. , . . , . , , , . - , , . ISO 10993-15 2011 2 ( 106), , . . , ISO 10993-1 ISO 10993-17. 2 , , . . , . . ISO IEC . ISO 3585 Borosilicate glass 3.3 Properties ( 3.3. ) ISO 3696 Water for analytical laboratory use Specification and test methods ( . ) ISO 8044
5、 Corrosion of metals and alloys Basic terms and definitions ( . ) ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing ( . 1. ) ISO 10993-9 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation product
6、s ( . 9. ) ISO 10993-12 Biological evaluation of medical devices Part 12: Sample preparation and reference materials ( . 12. ) ISO 10993-13 Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices ( . 13. ISO 10993-15
7、2011 3 ) ISO 10993-14 Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics ( . 14. ) ISO 10993-16 Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables ( . 16. ) 3 ISO 10993-1, ISO 10993-9, ISO 10993-12, ISO 8044, : 3.1 : , () . 3.2 : , - . 3.3 : (. 1). 3.4 : , , - . 3.5 : , . 3.6 : , - . 3.7 : , (. . 1). 4 4.1 ISO 10993-15 2011 4 , , . : . . . ( ) / . . . 4.2 , , . () . , . 5 5.1 () . 5.2 () , . 2 ISO 3696. : - 0,9%- ; - ; - . ISO 10993-15 2011 5 . , . . 0,9%-
