DIN EN ISO 10993-6-2009 医疗设备的生物学评价.第6部分:植入后局部效果试验(ISO10993-6-2007);德文版本ENISO10993-6-2009
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【英文标准名称】:Biologicalevaluationofmedicaldevices-Part6:Testsforlocaleffectsafterimplantation(ISO10993-6:2007);EnglishversionofDINENISO10993-6:2009-08
【原文标准名称】:医疗设备的生物学评价.第6部分:植入后局部效果试验(ISO10993-6-2007);德文版本ENISO10993-6-2009
【标准号】:DINENISO10993-6-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-08
【实施或试行日期】:2009-08-01
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:生物测定;生物适应性;生物的;生物分析和试验;生物危害;生物试验;陶瓷;兼容性;定义;牙科设备;牙科材料;牙科学;测定;评定;实验动物;织物;精密机械;组织学;植入实验;植入物(外科);宏观的;材料;医疗器械;医疗设备;医疗仪器;医疗产品;医学科学;方法;肌肉;观察;高聚物;制剂(医疗);原理;生产;反应;试样;范围;固体;外科学;外科设备;外科植入物;取出;试验持续时间;试件;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】:C30
【国际标准分类号】:11_100_20
【页数】:30P.;A4
【正文语种】:英语
【原文标准名称】:医疗设备的生物学评价.第6部分:植入后局部效果试验(ISO10993-6-2007);德文版本ENISO10993-6-2009
【标准号】:DINENISO10993-6-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-08
【实施或试行日期】:2009-08-01
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:生物测定;生物适应性;生物的;生物分析和试验;生物危害;生物试验;陶瓷;兼容性;定义;牙科设备;牙科材料;牙科学;测定;评定;实验动物;织物;精密机械;组织学;植入实验;植入物(外科);宏观的;材料;医疗器械;医疗设备;医疗仪器;医疗产品;医学科学;方法;肌肉;观察;高聚物;制剂(医疗);原理;生产;反应;试样;范围;固体;外科学;外科设备;外科植入物;取出;试验持续时间;试件;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】:C30
【国际标准分类号】:11_100_20
【页数】:30P.;A4
【正文语种】:英语
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