【英文标准名称】:Biologicalevaluationofmedicaldevices-Part20:Principlesandmethodsforimmunotoxicologytestingofmedicaldevices
【原文标准名称】:医疗设备的生物评定.第20部分:医疗设备的免疫毒物学试验的原则和方法
【标准号】:ISO/TS10993-20-2006
【标准状态】:现行
【国别】:国际
【发布日期】:2006-08
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC194
【标准类型】:()
【标准水平】:()
【中文主题词】:畜牧业;抗体;生物测定;生物分析和试验;定义;牙科设备;牙科材料;测定;评定;萃取;保健;外科植入物;极限(数学);测量;医疗设备;医疗产品;分析方法;质量保证;质量保证体系;残留物含量;残留物;规范(验收);试样制备;外科设备;试验;毒性;证实
【英文主题词】:Animalhusbandry;Antibodies;Bioassay;Biologicalanalysisandtesting;Definitions;Dentalequipment;Dentalmaterials;Determination;Evaluations;Extraction;Healthprotection;Implants(surgical);Limits(mathematics);Measurement;Medicaldevices;Medicalequipment;Medicalproducts;Methodsofanalysis;Qualityassurance;Qualityassurancesystems;Residualcontent;Residue;Residues;Specification(approval);Specimenpreparation;Surgicalequipment;Surgicalimplants;Testing;Toxicity;Validation
【摘要】:ThispartofISO10993presentsanoverviewofimmunotoxicologywithparticularreferencetothepotentialimmunotoxicityofmedicaldevices.Itgivesguidanceonmethodsfortestingforimmunotoxicityofvarioustypesofmedicaldevices.ThispartofISO10993isbasedonseveralpublicationswrittenbyvariousgroupsofimmunotoxicologistsoverthelastfewdecadesinwhichthedevelopmentofimmunotoxicologyasaseparateentitywithintoxicologytookplace.ThecurrentstateofknowledgewithregardtoimmunotoxicityisdescribedinAnnexA.AsummaryofclinicalexperiencetodatewithimmunotoxicologyassociatedwithmedicaldevicesisgiveninAnnexB.NOTESeealsoBibliographicReference[11].
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:17P.;A4
【正文语种】:英语