BS ISO 16054-2001 外科植入物.外科植入物的最小数据集
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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集
【标准号】:BSISO16054-2001
【标准状态】:现行
【国别】:英国
【发布日期】:2001-03-15
【实施或试行日期】:2001-03-15
【发布单位】:英国标准学会(BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:医疗设备;识别方法;外科植入物;外科设备;数据集;矫形外科设备;信息交流;数据;寄存器(计算机)
【英文主题词】:medicalsciences;specification(approval);definitions;surgicalimplants;informationexchange;datarecords;finemechanics;definition;international;ceramic;sintered;implants(surgical);ceramics;surgery
【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】:12P;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集
【标准号】:BSISO16054-2001
【标准状态】:现行
【国别】:英国
【发布日期】:2001-03-15
【实施或试行日期】:2001-03-15
【发布单位】:英国标准学会(BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:医疗设备;识别方法;外科植入物;外科设备;数据集;矫形外科设备;信息交流;数据;寄存器(计算机)
【英文主题词】:medicalsciences;specification(approval);definitions;surgicalimplants;informationexchange;datarecords;finemechanics;definition;international;ceramic;sintered;implants(surgical);ceramics;surgery
【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】:12P;A4
【正文语种】:英语
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