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【英文标准名称】:Biologicalevaluationofmedicaldevices.Testsforirritationandskinsensitization
【原文标准名称】:医疗设备的生物学评价.刺激和皮肤过敏化试验
【标准号】:BSENISO10993-10-2010
【标准状态】:现行
【国别】:英国
【发布日期】:2010-10-31
【实施或试行日期】:2010-10-31
【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】:过敏性反应;动物;生物测定;生物的;生物分析和试验;生物危害;生物试验;化合物;分类;减速度;定义(术语);牙科设备;牙科学;敏感性测定;评定;眼睛;在体外;在体内;材料;医疗器械;医疗器材;医疗产品;方法;观察;计划;兔;样品;选择;致敏性;副作用;皮肤;皮肤接触;外科设备;外科植入物;试验动物;试验性能;测试;试验
【英文主题词】:Allergies;Animals;Bioassay;Biological;Biologicalanalysisandtesting;Biologicalhazards;Biologicaltests;Chemicals;Classification;Deceleration;Definitions;Dentalequipment;Dentistry;Determinationsofsusceptibility;Evaluations;Eyes;Invitro;Invivo;Materials;Medicaldevices;Medicalequipment;Medicalproducts;Methods;Observation;Planning;Rabbits;Samples;Selection;Sensitization;Sideeffects;Skin(body);Skincontact;Surgicalequipment;Surgicalimplants;Testanimals;Testperformance;Testing;Trials
【摘要】:ThispartofISO10993describestheprocedurefortheassessmentofmedicaldevicesandtheirconstituentmaterialswithregardtotheirpotentialtoproduceirritationandskinsensitization.ThispartofISO10993includes:a)pretestconsiderationsforirritation,includinginsilicoandinvitromethodsfordermalexposure;b)detailsofinvivo(irritationandsensitization)testprocedures;c)keyfactorsfortheinterpretationoftheresults.InstructionsaregiveninAnnexAforthepreparationofmaterialsspecificallyinrelationtotheabovetests.InAnnexBseveralspecialirritationtestsaredescribedforapplicationofmedicaldevicesinareasotherthanskin.
【中国标准分类号】:C37
【国际标准分类号】:11_100_20
【页数】:74P;A4
【正文语种】:英语