ISO 10993-12-2007 医疗器械的生物学评估.第12部分:样品制备和参考材料
作者:标准资料网
时间:2024-05-10 17:52:08
浏览:9400
来源:标准资料网
下载地址: 点击此处下载
【英文标准名称】:Biologicalevaluationofmedicaldevices-Part12:Samplepreparationandreferencematerials
【原文标准名称】:医疗器械的生物学评估.第12部分:样品制备和参考材料
【标准号】:ISO10993-12-2007
【标准状态】:作废
【国别】:国际
【发布日期】:2007-11
【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;生物试验;定义;牙科设备;牙科器械;评定;萃取;医疗设备;医疗产品;参考材料;规范(验收);试样制备;外科设备;外科植入物;手术器械;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】:17P;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:样品制备和参考材料
【标准号】:ISO10993-12-2007
【标准状态】:作废
【国别】:国际
【发布日期】:2007-11
【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;生物试验;定义;牙科设备;牙科器械;评定;萃取;医疗设备;医疗产品;参考材料;规范(验收);试样制备;外科设备;外科植入物;手术器械;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】:17P;A4
【正文语种】:英语
下载地址:
点击此处下载