1、 , () INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) 14 (ISO 10993-14:2001, IDT) 2013 ISO 10993-14 2011 IS 10993-142011 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 . 1303- ISO 10993-142011
2、1 2013 . 5 ISO 10993-14:2001 Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics ( . 14. ). (IDT). 10993-142009. 6 ( ) , . C, 2013 , IS 10993-142011 IV ISO 10993 . . , -, . ISO 10993 , , . ISO 10993 . : 1 ; 2 ; 3 , ; 4 , ; 5 : in
3、vitro; 6 ; 7 ; 9 ; 10 ; 11 ; 12 ; 13 ; 14 ; IS 10993-142011 V 15 ; 16 ; 17 ; 18 ; 19 -, ; 20 . , . , , , , ISO 10993-1. IS 10993-142011 1 14 Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics 20130101 1 , , : -
4、; - . . , , , , ISO 10993-1. 2 IS 10993-142011 2 : ISO 3310-1 Test sieves Technical requirements and testing Part 1: Test sieves of metal wire cloth ( . . 1. ) ISO 3696 Water for analytical laboratory use Specification and test methods ( . ) ISO 5017 Dense shaped refractory products - Determination
5、of bulk density, apparent porosity and true porosity ( . , ) ISO 6474 Implants for surgery eramic materials based on high purity alumina ( . ) ISO 6872:1995 Dental ceramic ( ) ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing ( . 1. ) ISO 10993-9 Biological evaluati
6、on of medical devices Part 9: Framework for identification and quantification of potential degradation products . 9. . 3 ISO 10993-1, ISO 10993-9, : 3.1 : , . 3.2 : , . 3.3 : , . 3.4 : , . IS 10993-142011 34 4.1 : - . - ; - . , in vivo. 1 -, . , . , , . IS 10993-142011 4 1 - 5 100 3 ? 10 5 ? IS 1099
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