ISO 16054-2000 外科植入物.外科植入物的最小数据组
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【英文标准名称】:Implantsforsurgery-Minimumdatasetsforsurgicalimplants
【原文标准名称】:外科植入物.外科植入物的最小数据组
【标准号】:ISO16054-2000
【标准状态】:现行
【国别】:国际
【发布日期】:2000-12
【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】:陶瓷;数据记录;定义;精密机械;外科植入物;信息交流;国际的;医学科学;烧结的;规范(验收);外科学
【英文主题词】:Ceramic;Ceramics;Datarecords;Definitions;Finemechanics;Implants(surgical);Informationexchange;International;Medicalsciences;Sintered;Specification(approval);Surgery;Surgicalimplants
【摘要】:ThisInternationalStandarddefinesminimumdatasetsforsurgicalimplantstofacilitaterecordingandinternationalexchangeofdataforthepurposesofimplantregistryandtrackingsystemsandforretrievalanalysis.Minimumdatacollectionrequirementsarespecifiedforthepurposeofimplanttrackingtoallowrecallforproductcorrectionorpa-tientfollowupintheeventofunforeseendevicemalfunction.Theminimumdatasetalsofulfilsthecoredatarequire-mentstoallowcrossreferencingbetweenextendeddatasetsforthepurposesofretrievalanalysisandresearch.ThisInternationalStandardisapplicabletothemanufacturersanddistributorsofmedicaldevicesintendedforper-manentimplant,i.e.morethan30daysandtothosehospitalsandothermedicalfacilitieswhichcarryoutimplantprocedures.Itspecifiesrequirementsfordataitemstoberecordedbythemanufacturersanddistributorsofperma-nentlyimplantablemedicaldevicesandbyhospitalsandothermedicalfacilitiesatboththetimeofimplantandatthetimeofanysubsequentexplantprocedure.ThisInternationalStandardisintendedtodefineaminimumdatasettoberecordedforallimplantandexplantevents,aswellasprovidingforthetimelyretrievalofminimumimplantdatarelatedtospecificsubsetsofpatientswhohavereceivedspecificidentifieddevicesordeviceswithinaspecifiedrangeoflot,batchorserialnumbers,forthepurposeofpatientfollowup.ItisnottheintentofthisInternationalStandardtoprovideameansofdatarecoverywhichisrelatedtospecificmedicalpractitioners,medicalfacilitiesormanufacturersforpurposesotherthanpatientfollowup.NOTEUsersofthisInternationalStandardshouldensurecompliancewithappropriatenationalstandardsorregulationscon-cerningdataprotectionandhandling.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:4P.;A4
【正文语种】:英语
【原文标准名称】:外科植入物.外科植入物的最小数据组
【标准号】:ISO16054-2000
【标准状态】:现行
【国别】:国际
【发布日期】:2000-12
【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】:陶瓷;数据记录;定义;精密机械;外科植入物;信息交流;国际的;医学科学;烧结的;规范(验收);外科学
【英文主题词】:Ceramic;Ceramics;Datarecords;Definitions;Finemechanics;Implants(surgical);Informationexchange;International;Medicalsciences;Sintered;Specification(approval);Surgery;Surgicalimplants
【摘要】:ThisInternationalStandarddefinesminimumdatasetsforsurgicalimplantstofacilitaterecordingandinternationalexchangeofdataforthepurposesofimplantregistryandtrackingsystemsandforretrievalanalysis.Minimumdatacollectionrequirementsarespecifiedforthepurposeofimplanttrackingtoallowrecallforproductcorrectionorpa-tientfollowupintheeventofunforeseendevicemalfunction.Theminimumdatasetalsofulfilsthecoredatarequire-mentstoallowcrossreferencingbetweenextendeddatasetsforthepurposesofretrievalanalysisandresearch.ThisInternationalStandardisapplicabletothemanufacturersanddistributorsofmedicaldevicesintendedforper-manentimplant,i.e.morethan30daysandtothosehospitalsandothermedicalfacilitieswhichcarryoutimplantprocedures.Itspecifiesrequirementsfordataitemstoberecordedbythemanufacturersanddistributorsofperma-nentlyimplantablemedicaldevicesandbyhospitalsandothermedicalfacilitiesatboththetimeofimplantandatthetimeofanysubsequentexplantprocedure.ThisInternationalStandardisintendedtodefineaminimumdatasettoberecordedforallimplantandexplantevents,aswellasprovidingforthetimelyretrievalofminimumimplantdatarelatedtospecificsubsetsofpatientswhohavereceivedspecificidentifieddevicesordeviceswithinaspecifiedrangeoflot,batchorserialnumbers,forthepurposeofpatientfollowup.ItisnottheintentofthisInternationalStandardtoprovideameansofdatarecoverywhichisrelatedtospecificmedicalpractitioners,medicalfacilitiesormanufacturersforpurposesotherthanpatientfollowup.NOTEUsersofthisInternationalStandardshouldensurecompliancewithappropriatenationalstandardsorregulationscon-cerningdataprotectionandhandling.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:4P.;A4
【正文语种】:英语
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