ISO 10993-12-2002 医疗器械的生物评定.第12部分:样品制备和标准样品

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【英文标准名称】:Biologicalevaluationofmedicaldevices-Part12:Samplepreparationandreferencematerials
【原文标准名称】:医疗器械的生物评定.第12部分:样品制备和标准样品
【标准号】:ISO10993-12-2002
【标准状态】:作废
【国别】:国际
【发布日期】:2002-12
【实施或试行日期】:
【发布单位】:国际标准化组织(ISO)
【起草单位】:ISO/TC194
【标准类型】:()
【标准水平】:()
【中文主题词】:生物试验;参考材料;规范(验收);外科植入物;医疗设备;定义;外科设备;牙科器械;试样制备;医疗产品;牙科设备;手术器械;试验
【英文主题词】:Bioassay;Biologicaltests;Definition;Definitions;Dentalequipment;Dentalinstruments;Evaluations;Extraction;Medicalequipment;Medicalproducts;Referencematerials;Specification(approval);Specimenpreparation;Surgicalequipment;Surgicalimplants;Surgicalinstruments;Testing
【摘要】:ThispartofISO10993specifiesrequirementsandgivesguidanceontheprocedurestobefollowedinthepreparationofsamplesandtheselectionofreferencematerialsformedicaldevicestestinginbiologicalsystemsinaccordancewithoneormorepartsoftheISO10993series.Specifically,thispartofISO10993addresses:—testmaterialselection;—selectionofrepresentativeportionsfromadevice;—testsamplepreparation;—experimentalcontrols;—selectionofandrequirementsforreferencematerials;and—preparationofextracts.TheapplicabilityofthispartofISO10993toabsorbablematerials,materialsthatpolymerizeinsitu,tissue-engineeredmedicalproductsandmaterialsofbiologicaloriginshouldbecarefullyevaluated.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:15P.;A4
【正文语种】:英语