BS EN ISO 10993-12-2009 医疗器械的生物学评估.第12部分:样品制备和参考物质(ISO10993-12-2007)
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【英文标准名称】:Biologicalevaluationofmedicaldevices-Part12:Samplepreparationandreferencematerials(ISO10993-12:2007)
【原文标准名称】:医疗器械的生物学评估.第12部分:样品制备和参考物质(ISO10993-12-2007)
【标准号】:BSENISO10993-12-2009
【标准状态】:作废
【国别】:英国
【发布日期】:2009-07-31
【实施或试行日期】:2009-07-31
【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】:生物测定;生物的;生物试验;认证;检查;条件;致癌力;定义(术语);牙科设备;牙科器械;评估;萃取;浸渍物;植入物(外科);材料;医疗器械;医疗设备;医疗产品;颗粒;式样;准备;生产;标准物质;参考;试样;选择;规范(验收);试样制备;标准;表面;外科设备;外科植入物;手术器械;温度;测试
【英文主题词】:Bioassay;Biological;Biologicaltests;Certification;Checks;Conditions;Cytotoxicity;Definitions;Dentalequipment;Dentalinstruments;Evaluations;Extraction;Extracts;Implants(surgical);Materials;Medicaldevices;Medicalequipment;Medicalproducts;Particles;Patterns;Preparation;Production;Referencematerials;References;Samples;Selection;Specification(approval);Specimenpreparation;Standards;Surfaces;Surgicalequipment;Surgicalimplants;Surgicalinstruments;Temperature;Testing
【摘要】:ThispartofISO10993specifiesrequirementsandgivesguidanceontheprocedurestobefollowedinthepreparationofsamplesandtheselectionofreferencematerialsformedicaldevicetestinginbiologicalsystemsinaccordancewithoneormorepartsoftheISO10993series.SpecificallythispartofISO10993addresses:-testsampleselection;-selectionofrepresentativeportionsfromadevice;-testsamplepreparation;-experimentalcontrols;-selectionofandrequirementsforreferencematerials;-preparationofextracts.ThispartofISO10993isnotapplicabletomaterialsordevicescontaininglivecells.
【中国标准分类号】:C37
【国际标准分类号】:11_100_20
【页数】:28P.;A4
【正文语种】:英语
【原文标准名称】:医疗器械的生物学评估.第12部分:样品制备和参考物质(ISO10993-12-2007)
【标准号】:BSENISO10993-12-2009
【标准状态】:作废
【国别】:英国
【发布日期】:2009-07-31
【实施或试行日期】:2009-07-31
【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】:生物测定;生物的;生物试验;认证;检查;条件;致癌力;定义(术语);牙科设备;牙科器械;评估;萃取;浸渍物;植入物(外科);材料;医疗器械;医疗设备;医疗产品;颗粒;式样;准备;生产;标准物质;参考;试样;选择;规范(验收);试样制备;标准;表面;外科设备;外科植入物;手术器械;温度;测试
【英文主题词】:Bioassay;Biological;Biologicaltests;Certification;Checks;Conditions;Cytotoxicity;Definitions;Dentalequipment;Dentalinstruments;Evaluations;Extraction;Extracts;Implants(surgical);Materials;Medicaldevices;Medicalequipment;Medicalproducts;Particles;Patterns;Preparation;Production;Referencematerials;References;Samples;Selection;Specification(approval);Specimenpreparation;Standards;Surfaces;Surgicalequipment;Surgicalimplants;Surgicalinstruments;Temperature;Testing
【摘要】:ThispartofISO10993specifiesrequirementsandgivesguidanceontheprocedurestobefollowedinthepreparationofsamplesandtheselectionofreferencematerialsformedicaldevicetestinginbiologicalsystemsinaccordancewithoneormorepartsoftheISO10993series.SpecificallythispartofISO10993addresses:-testsampleselection;-selectionofrepresentativeportionsfromadevice;-testsamplepreparation;-experimentalcontrols;-selectionofandrequirementsforreferencematerials;-preparationofextracts.ThispartofISO10993isnotapplicabletomaterialsordevicescontaininglivecells.
【中国标准分类号】:C37
【国际标准分类号】:11_100_20
【页数】:28P.;A4
【正文语种】:英语
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