【英文标准名称】:Biologicalevaluationofmedicaldevices-Testsforgenotoxicity,carcinogenicityandreproductivetoxicity
【原文标准名称】:医疗器械的生物评定.遗传毒性、致癌性和生殖毒性试验
【标准号】:BSENISO10993-3-2003
【标准状态】:作废
【国别】:英国
【发布日期】:2003-10-31
【实施或试行日期】:2003-10-31
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:生物测定;生物试验;致癌物材料;致癌物质;定义;牙科设备;牙科器械;牙科材料;精密机械;遗传学;遗传毒性;材料;医疗设备;医疗产品;医学科学;生殖系统;外科设备;外科植入物;测试;毒性
【英文主题词】:Bioassay;Biological;Biologicalhazards;Biologicaltests;Carcinogenicmaterials;Carcinogens;Definitions;Dentalequipment;Dentalinstruments;Dentalmaterials;Evaluations;Finemechanics;Genes;Genetics;Genotoxicity;Implants(surgical);Materials;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Methods;Preparation;Reproductions;Reproductivesystem;Samples;Surgicalequipment;Surgicalimplants;Testing;Toxicity
【摘要】:ISO10993-3:2003specifiesstrategiesforhazardidentificationandtestsonmedicaldevicesforthefollowingbiologicalaspects:genotoxicity,carcinogenicity,andreproductiveanddevelopmentaltoxicity.ISO10993-3:2003isapplicableforevaluationofamedicaldevicewhosepotentialforgenotoxicity,carcinogenicityorreproductivetoxicityhasbeenidentified.GuidanceonselectionoftestsisprovidedinISO10993-1.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:28P;A4
【正文语种】:英语