BS EN 12006-2-1998+A1-2009 非活性外科植入物.心脏和血管植入物的特殊要求.包括心瓣导管在内的血管假体
作者:标准资料网 时间:2024-05-21 01:22:59 浏览:8532
来源:标准资料网
下载地址: 点击此处下载
【英文标准名称】:Non-activesurgicalimplants-Particularrequirementsforcardiacandvascularimplants-Vascularprosthesesincludingcardiacvalveconduits
【原文标准名称】:非活性外科植入物.心脏和血管植入物的特殊要求.包括心瓣导管在内的血管假体
【标准号】:BSEN12006-2-1998+A1-2009
【标准状态】:现行
【国别】:英国
【发布日期】:1998-07-15
【实施或试行日期】:1998-07-15
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:生物的;生物危害;结合;心脏瓣膜;心动描记法;化学性质;兼容性;定义;设计;尺寸;评估;心脏;植入物(外科);信息;检验;标志;材料;测量;机械性能;医疗技术学;命名;包装件;生产;修复装置;质量保证;抽样方法;规范(验收);稳定性;状态;灭菌;外科学;外科植入物;测试;血管假体;验证
【英文主题词】:Biological;Biologicalhazards;Bond;Cardiacvalves;Cardiography;Chemicalproperties;Compatibility;Definitions;Design;Dimensions;Evaluations;Heart;Implants(surgical);Information;Inspection;Marking;Materials;Measurement;Mechanicalproperties;Medicaltechnology;Nomenclature;Packages;Production;Prostheticdevices;Qualityassurance;Samplingmethods;Specification(approval);Stability;Status;Sterilization(hygiene);Surgery;Surgicalimplants;Testing;Vascularprostheses;Verification
【摘要】:Thisstandarddescribesspecificrequirementsforvascularprostheses,includingcardiacvalveconduits,ofsyntheticorbiologicaloriginintendedtoreplace,toreconstruct,tobypassortoformshuntsbetweensegmentsofthecardio-vascularsysteminhumans.ThisEuropeanStandardisnotapplicabletoprosthesesderivedfromhosttissue(autografts).NOTEAvalveconduitisregardedasacompositeprosthesisandfallswithinthescopeofthisstandard.WithregardtosafetyitgivesinadditiontoENISO14630:1997,requirementsforintendedperformance,designattributes,materials,designevaluation,manufacturing,sterilization,packagingandinformationsuppliedbythemanufacturer.ThisEuropeanStandardspecifiesthedesignationofmaterialsofthemanufacturerandtheconstructionofthedevice,andthedesignationofsizesanddimensionsofvascularprostheses.ItspecifiesbiologicalrequirementsforthematerialsofconstructionandforthefinishedproductbyreferencestoappropriateInternationalandEuropeanStandards.InadditionthisEuropeanStandardspecifiesthedesignationofmechanicalproperties.Itdescribesmethodsforthemeasurementandverificationofthedimensionsandmechanicalpropertiesstatedbythemanufacturer,includingdurabilitytesting.Thisstandardalsogivesrequirementsforpackagingandlabelling.Itprovidesdefinitionsofthetermsincommonuse.ThisEuropeanStandarddoesnotspecifyallpossibleperformanceordimensionalcharacteristics.Insuchcases,theEuropeanStandarddoeshoweverincludemethodstoverifythenominalvaluesstatedbythemanufacturer.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:16P.;A4
【正文语种】:英语
【原文标准名称】:非活性外科植入物.心脏和血管植入物的特殊要求.包括心瓣导管在内的血管假体
【标准号】:BSEN12006-2-1998+A1-2009
【标准状态】:现行
【国别】:英国
【发布日期】:1998-07-15
【实施或试行日期】:1998-07-15
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:生物的;生物危害;结合;心脏瓣膜;心动描记法;化学性质;兼容性;定义;设计;尺寸;评估;心脏;植入物(外科);信息;检验;标志;材料;测量;机械性能;医疗技术学;命名;包装件;生产;修复装置;质量保证;抽样方法;规范(验收);稳定性;状态;灭菌;外科学;外科植入物;测试;血管假体;验证
【英文主题词】:Biological;Biologicalhazards;Bond;Cardiacvalves;Cardiography;Chemicalproperties;Compatibility;Definitions;Design;Dimensions;Evaluations;Heart;Implants(surgical);Information;Inspection;Marking;Materials;Measurement;Mechanicalproperties;Medicaltechnology;Nomenclature;Packages;Production;Prostheticdevices;Qualityassurance;Samplingmethods;Specification(approval);Stability;Status;Sterilization(hygiene);Surgery;Surgicalimplants;Testing;Vascularprostheses;Verification
【摘要】:Thisstandarddescribesspecificrequirementsforvascularprostheses,includingcardiacvalveconduits,ofsyntheticorbiologicaloriginintendedtoreplace,toreconstruct,tobypassortoformshuntsbetweensegmentsofthecardio-vascularsysteminhumans.ThisEuropeanStandardisnotapplicabletoprosthesesderivedfromhosttissue(autografts).NOTEAvalveconduitisregardedasacompositeprosthesisandfallswithinthescopeofthisstandard.WithregardtosafetyitgivesinadditiontoENISO14630:1997,requirementsforintendedperformance,designattributes,materials,designevaluation,manufacturing,sterilization,packagingandinformationsuppliedbythemanufacturer.ThisEuropeanStandardspecifiesthedesignationofmaterialsofthemanufacturerandtheconstructionofthedevice,andthedesignationofsizesanddimensionsofvascularprostheses.ItspecifiesbiologicalrequirementsforthematerialsofconstructionandforthefinishedproductbyreferencestoappropriateInternationalandEuropeanStandards.InadditionthisEuropeanStandardspecifiesthedesignationofmechanicalproperties.Itdescribesmethodsforthemeasurementandverificationofthedimensionsandmechanicalpropertiesstatedbythemanufacturer,includingdurabilitytesting.Thisstandardalsogivesrequirementsforpackagingandlabelling.Itprovidesdefinitionsofthetermsincommonuse.ThisEuropeanStandarddoesnotspecifyallpossibleperformanceordimensionalcharacteristics.Insuchcases,theEuropeanStandarddoeshoweverincludemethodstoverifythenominalvaluesstatedbythemanufacturer.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:16P.;A4
【正文语种】:英语
下载地址: 点击此处下载
