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有些内容是版主的，我只是自己整理了下，与各位分享。（绿色是和ISO一致，红色是未协调的）
生物学评价目录 ISO10993 ISO 10993-1-2009《Biological evaluation of medical devices. Part 1:Evaluationand testing within a risk management process》 ISO 10993-1-2009/Cor 1-2010《Corrigendum 1:Biological evaluation of medical devices. Part1:Evaluation and testing within a risk management process》 ISO 10993-2-2006《Biological evaluation of medical devices. Part 2:Animalwelfare requirements second edition》 ISO 10993-3-2014《Biologicalevaluation of medical devices. Part 3:Tests for genotoxicity,carcinogenicityand reproductive toxicity》 ISO 10993-4-2017《Biologicalevaluation of medical devices. Part 4:Selection of tests for interactions withblood》 ISO 10993-5-2009《Biologicalevaluation of medical devices. Part 5:Tests for in vitro cytotoxicity》 ISO 10993-6-2016《Biologicalevaluation of medical devices. Part 6:Tests for local effects afterimplantation》 ISO 10993-7-2008《Biological evaluation of medical devices. Part 7:Ethyleneoxide sterilization residuals》 ISO 10993-9-2009《Biologicalevaluation of medical devices. Part 9:Framework for identification andquantification of potential degradation products second edition》 ISO 10993-10-2010《Biologicalevaluation of medical devices. Part 10:Tests for irritation and skin sensitization》 ISO 10993-11-2017《Biologicalevaluation of medical devices. Part 11: Tests for systemic toxicity》 ISO 10993-12-2012《Biologicalevaluation of medical devices. Part 12:Sample preparation and referencematerials》 ISO 10993-13-2010《Biologicalevaluation of medical devices. Part 13:Identification and quantification ofdegradation products from polymeric medical devices second edit》 ISO 10993-14-2001《Biological evaluation of medical devices. Part14:Identification and quantification of degradation products from ceramicsfirst edition》 ISO 10993-15-2001《Biological evaluation of medical devices -- Part 15:Identification and quantification of degradation products from metals andalloys》 ISO 10993-16-2017 《Biological evaluation of medical devices. Part16:Toxicokinetic study design for degradation products and leachables》 ISO 10993-17-2002《Biological evaluation of medical devices. Part17:Establishment of allowable limits for leachable substances first edition》 ISO 10993-18-2005《Biological evaluation of medical devices. Part 18:Chemicalcharacterization of materials first edition》 ISO 10993-19-2006《Biologicalevaluation of medical devices. Part 19:physico-chemical、morphological andtopographical characterization of materials》 ISO 10993-20-2006 《Biologicalevaluation of medical devices. Part 20：Principles and methods forimmunotoxicology testing of medical devices》
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发表于 2017-11-21 11:12:48
置顶卡
变色卡
这是弃暗投明，还是步入火坑啊
