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            標準及技術更新一

            1) ISO 10993-3:2003 Biological evaluation of medical devices—Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity;

            2)ISO 10993-4:2002+Amd 1:2006: Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood;

            3)ISO 10993-5:2009: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity;

            4)ISO 10993-6:2007 Biological evaluation of medical devices—Part 6: Test for local effects after implantation;

            5)ISO 10993-10:2010: Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization;

            6)ISO 10993-12:2007: Biological evaluation of medical devices - Part 12: Sample preparation and reference materials;

            7)ISO 10993-13:1998 Biological evaluation of medical devices-Part 13: Identifition and quantification of degradation products from polymeric medical devices;

            8)ISO 10993-14:2001 Biological evaluation of medical devices- Part 14: Identification and quantification of degradation products from ceramics;

            9)ISO 10993-20: 2006 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices;
             
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