ISO 10993-6-2007 医用装置的生物学评估.第6部分:植入后局部效应试验

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【英文标准名称】:Biologicalevaluationofmedicaldevices-Part6:Testsforlocaleffectsafterimplantation
【原文标准名称】:医用装置的生物学评估.第6部分:植入后局部效应试验
【标准号】:ISO10993-6-2007
【标准状态】:现行
【国别】:国际
【发布日期】:2007-04
【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】:生物测定;生物分析和测试;生物试验;兼容性;定义;牙科设备;牙科材料;牙科学;测定;精密机械;植入试验;材料;医用设备;医用仪器;医疗产品;医学科学;方法;外科学;外科设备;外科植入物;测试;
【英文主题词】:Bioassay;Biocompatibility;Biological;Biologicalanalysisandtesting;Biologicalhazards;Biologicaltests;Ceramics;Compatibility;Definitions;Dentalequipment;Dentalmaterials;Dentistry;Determination;Evaluations;Experimentalanimals;Fabrics;Finemechanics;Histology;Implantationtest;Implants(surgical);Macroscopic;Materials;Medicaldevices;Medicalequipment;Medicalinstruments;Medicalproducts;Medicalsciences;Methods;Muscles;Observation;Polymers;Preparation(medical);Principle;Production;Reaction;Samples;Scope;Solids;Surgery;Surgicalequipment;Surgicalimplants;Taking-out;Testduration;Testpieces;Testing
【摘要】:ThispartofISO10993specifiestestmethodsfortheassessmentofthelocaleffectsafterimplantationofbiomaterialsintendedforuseinmedicaldevices.ThispartofISO10993appliestomaterialsthatare:?solidandnon-biodegradable;?degradableand/orresorbable;?non-solid,suchasporousmaterials,liquids,pastesandparticulates.Thetestspecimenisimplantedintoasiteandanimalspeciesappropriatefortheevaluationofthebiologicalsafetyofthematerial.Theseimplantationtestsarenotintendedtoevaluateordeterminetheperformanceofthetestspecimenintermsofmechanicalorfunctionalloading.ThispartofISO10993mayalsobeappliedtomedicaldevicesthatareintendedtobeusedtopicallyinclinicalindicationswherethesurfaceorliningmayhavebeenbreached,inordertoevaluatelocaltissueresponses.Thelocaleffectsareevaluatedbyacomparisonofthetissueresponsecausedbyatestspecimentothatcausedbycontrolmaterialsusedinmedicaldevicesofwhichtheclinicalacceptabilityandbiocompatibilitycharacteristicshavebeenestablished.Theobjectiveofthetestmethodsistocharacterizethehistoryandevolutionofthetissueresponseafterimplantationofamedicaldevice/biomaterialincludingfinalintegrationorresorption/degradationofthematerial.Inparticularfordegradable/resorbablematerialsthedegradationcharacteristicsofthematerialandtheresultingtissueresponseshouldbedetermined.ThispartofISO10993doesnotdealwithsystemictoxicity,carcinogenicity,teratogenicityormutagenicity.However,thelong-termimplantationstudiesintendedforevaluationoflocalbiologicaleffectsmayprovideinsightintosomeoftheseproperties.SystemictoxicitystudiesconductedbyimplantationmaysatisfytherequirementsofthispartofISO10993
【中国标准分类号】:C33;C35
【国际标准分类号】:11_100_20
【页数】:21P;A4
【正文语种】:英语