【英文标准名称】:Biologicalevaluationofmedicaldevices.Testsforlocaleffectsafterimplantation
【原文标准名称】:医疗器械的生物学评价.植入后的局部效应试验
【标准号】:BSENISO10993-6-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2009-06-30
【实施或试行日期】:2009-06-30
【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;评估;实验动物;织物;精密机械;组织学;移植试验;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(医学);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;试验
【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】:32P.;A4
【正文语种】:英语


【英文标准名称】:Clearliquids-Estimationofcolourbytheplatinum-cobaltscale-Part1:Visualmethod(ISO6271-1:2004);GermanversionENISO6271:2004
【原文标准名称】:透明液体.用铂钴标度评定颜色.第1部分:目测法
【标准号】:DINENISO6271-1-2005
【标准状态】:现行
【国别】:德国
【发布日期】:2005-03
【实施或试行日期】:
【发布单位】:德国标准化学会(DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:三原色;着色值;比色;清漆;暗色调;APHA色数;涂料;填充料;定义;添加剂;试验设备;粘合剂;颜色;哈森色数;估计;测定;溶剂;比较测量;铂-钴标度;试验;分类;液体;外观检查(试验);比色法;标准颜色
【英文主题词】:
【摘要】:Thestandardspecifiesamethodforestimationgthecolour,inPt-Counits,ofclearliquids.Itisapplicabletoclearliquidshavingcolourcharacteristicssimilartothoseofthereferenceplatinum-cobaltscale.
【中国标准分类号】:G04
【国际标准分类号】:17_180_20;87_060_20
【页数】:10P;A4
【正文语种】:德语