【英文标准名称】:Retrievalandanalysisofsurgicalimplants-Part4:Analysisofretrievedceramicsurgicalimplants
【原文标准名称】:外科植入物的分析和取出.第4部分:取出的陶瓷外科植入物的分析
【标准号】:ISO12891-4-2000
【标准状态】:现行
【国别】:国际
【发布日期】:2000-02
【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/TC150
【标准类型】:()
【标准水平】:()
【中文主题词】:分析;取出;生物测定;医疗产品;外科植入物;化学分析和试验;医疗技术学;陶瓷;处理
【英文主题词】:analysis;taking-out;bioassay;medicalproducts;surgicalimplants;chemicalanalysisandtesting;medicaltechnology;ceramics;handling
【摘要】:ThevariouspartsofISO12891giverecommendationsfortheretrieval,handlingandanalysisofsurgicalimplantsandassociatedspecimenswhichareremovedfrompatientsroutinely,duringrevisionsurgeryorpost-mortem.Theaimistoprovideguidanceinpreventingdamagetothespecimenswhichcouldobscuretheinvestigationresults,andingatheringdataatthepropertimeandunderthepropercircumstancestovalidatethestudy.Part1dealswithretrievalandhandling.Parts2to4concerntheanalysisofimplantsofspecificmaterials,includingprotocolsforreportingthedatacollected.Forparticularinvestigationprogrammes,additional,morespecific,protocolsmayberequired.Ifspecialanalyticaltechniquesareemployed,theappropriateproceduresshouldbespecified.ThispartofISO12891providesguidanceontheanalysisofretrievedceramicsurgicalimplants.Forgeneralinformationonceramics,seethebibliography.Theinvestigationisdividedintothreestagesthatareincreasinglydestructive.Thestageandtypeofinvestigationshouldbechosenasafunctionofthetypeofimplantandthepurposeoftheinvestigation.ThispartofISO12891concerns"dense","stable"ceramicssuchasaluminaandtetragonalzirconia.However,wheresuitable,sectionsofthispartofISO12891maybealsoappliedtolessstableceramicslikehydroxyapatiteorbio-accessibleceramicsliketricalciumphosphate.Inclause6,someprovisionsaremadeforanalysesofsuchtypesofceramic.ThispartofISO12891shouldbeusedinaccordancewithnationalregulationsorlegalrequirementsconcerningthehandlingandanalysisofretrievedimplantsandtissuesandassociatedbiologicalmaterial.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:18P.;A4
【正文语种】:英语