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ISO10993介绍


    材料生物相容性评价标准,ISO10993体系介绍如下:
 
  ISO10993-1:2009风险管理程序中的评价和测试
 
  BiologicalevaluationofmedicaldevicesPart1:Evaluationandtestingintheriskmanagementprocess
 
  ISO10993-2:2006动物保护要求
 
  BiologicalevaluationofmedicaldevicesPart2:Animalwelfarerequirements
 
  ISO10993-3:2003遗传毒性、致癌毒性和生殖毒性试验
 
  BiologicalevaluationofmedicaldevicesPart3:Testsforgenotoxicity,carcinogenicityandreproductivetoxicity
 
  ISO10993-4:2002/Amd1:2006与血液相互作用试验选择
 
  BiologicalevaluationofmedicaldevicesPart4:Selectionoftestsforinteractionswithblood
 
  ISO10993-5:2009体外细胞毒性试验
 
  BiologicalevaluationofmedicaldevicesPart5:Testsforinvitrocytotoxicity
 
  ISO10993-6:2007植入后局部反应试验
 
  BiologicalevaluationofmedicaldevicesPart6:Testsforlocaleffectsafterimplantation
 
  ISO10993-7:2008环氧乙烷残留限量
 
  BiologicalevaluationofmedicaldevicesPart7:Ethyleneoxidesterilizationresiduals
 
  ISO10993-8:2001生物试验用参考材料的选择和条件
 
  BiologicalevaluationofmedicaldevicesPart8:Selectionofreferencematerials
 
  ISO10993-9:1999潜在降解产物定性与定量框架
 
  BiologicalevaluationofmedicaldevicesPart9:Frameworkforidentificationandquantificationofpotentialdegradationproducts
 
  ISO10993-10:2010刺激和皮肤敏化试验
 
  BiologicalevaluationofmedicaldevicesPart10:Testsforirritationanddelayed-typehypersensitivity
 
  ISO10993-11:2006全身毒性试验
 
  BiologicalevaluationofmedicaldevicesPart11:Testsforsystemictoxicity
 
  ISO10993-12:2012样品制备与参照样品
 
  BiologicalevaluationofmedicaldevicesPart12:Samplepreparationandreferencematerials(availableinEnglishonly)
 
  ISO10993-13:1998聚合物医疗器械的降解产物定性与定量分析
 
  BiologicalevaluationofmedicaldevicesPart13:Identificationandquantificationofdegradationproductsfrompolymericmedicaldevices
 
  ISO10993-14:2001陶瓷降解产物定性与定量分析
 
  BiologicalevaluationofmedicaldevicesPart14:Identificationandquantificationofdegradationproductsfromceramics
 
  ISO10993-15:2000金属与合金降解产物定性与定量分析
 
  BiologicalevaluationofmedicaldevicesPart15:Identificationandquantificationofdegradationproductsfrommetalsandalloys
 
  ISO10993-16:1997降解产物与可沥滤物毒性动力学研究设计
 
  BiologicalevaluationofmedicaldevicesPart16:Toxicokineticstudydesignfordegradationproductsandleachables
 
  ISO10993-17:2002允许可沥滤物限制的建立
 
  BiologicalevaluationofmedicaldevicesPart17:Establishmentofallowablelimitsforleachablesubstances
 
  ISO10993-18:2005材料的化学特性
 
  BiologicalevaluationofmedicaldevicesPart18:Chemicalcharacterizationofmaterials
 
  ISO/TS10993-19:2006材料的物理化学、形态学和地形学特征
 
  BiologicalevaluationofmedicaldevicesPart19:Physico-chemical,morphologicalandtopographicalcharacterizationofmaterials
 
  ISO/TS10993-20:2006医疗器械的免疫毒性测试原则和方法
 
  BiologicalevaluationofmedicaldevicesPart20:Principlesandmethodsforimmunotoxicologytestingofmedicaldevices
 
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