风险管理对医疗器械的生物学评价

风险管理对医疗器械的生物学评价作者：薛淼，XueMiao作者单位：上海交通大学医学院附属第九人民医院,上海生物材料研究测试中心,上海,200023刊名：口腔材料器械杂志英文刊名：CHINESEJOURNALOFDENTALMATERIALSANDDEVICES年，卷(期)：2008,17(4)参考文献(24条)1.ISO10993-3.Testsforgenotoxicity,carcinogenicityandreproductivetoxicity2.ISO10993-2.Animalwelfarerequirements3.ISO10993-1.Evaluationandtestingwithinariskmanagementsystem4.ISO10993-1-2003.Biologicalevaluationofmedicaldevices-Part1.Evaluationandtesting5.ISO/IEC17025-2005.Generalrequirementsforthecompetenceoftestingandcalibrationlaboratories(检测和校准实验室能力的通用要求6.ISO/DIS10993-1-2007.IDTBiologicalevaluationofmedicaldevices-Part1.Evaluationandtestingwithinariskmanagementsystem7.YY/T0316-2003/ISO14971-2000.医疗器械风险管理对医疗器械的应用20038.ISO/TS10993-20.Biologicalevaluationofmedicaldevuces-Part20.Principlesandmethods,forimmunotoxicologytestingofmedicaldevices9.ISO/TS10993-19.Biologicalevaluationofmedicaldevuces-19.Physico-chemical,morphologicalandtopographicalcharacterizationofmaterials10.ISO10993-18.Chemicalcharacterizationofmaterials11.ISO10993-17.Establishmentofallowablelimitsforleacheblesubstances12.ISO10993-16.Toxicokineticstudydesighfordegradationproductsandleachebles13.ISO10993-4.Selectionoftestsforinteractionswithblood14.ISO10993-15.Identificationandquantificationofdegradationproductsfrommetalsandalloys15.ISO10993-9.Frameworkfortheidentificationandquantificationofpotentialdegradationproducts16.SixthWorldBiomaterialsCongress--BiologicalEvaluationofBiomaterials/AcceptabletoSafetoUse(21of31)200017.ISO10993-7.Ethyleneoxidesterilizationresiduals18.ISO10993-6.Testsforlocaleffectsafterimplantation19.ISO10993-14.Identificationandquantificationofdegradationproductsfromceramics20.ISO10993-13.Identificationandquantificationofdegradationproductsfrompolymericmedicaldevices21.ISO10993-12.Samplepreparationandreferencematerials22.ISO10993-11.Testsforsystemictoxicity23.ISO10993-10.Testsforirritationanddelayed-typehypersensitivity24.ISO10993-5.Testsforinvitrocytotoxicity本文链接：