DIN EN ISO 7197-2009 神经外科植入物.无菌、一次性使用的脑积水分流管和组件(ISO7197-2006,包括技术勘误1-2007);德文版本ENISO7197-2009
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【英文标准名称】:Neurosurgicalimplants-Sterile,single-usehydrocephalusshuntsandcomponents(ISO7197:2006,includingCor1:2007);EnglishversionofDINENISO7197:2009-08
【原文标准名称】:神经外科植入物.无菌、一次性使用的脑积水分流管和组件(ISO7197-2006,包括技术勘误1-2007);德文版本ENISO7197-2009
【标准号】:DINENISO7197-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-08
【实施或试行日期】:2009-08-01
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:制造日期;定义;名称与符号;英语;企业;一次性使用设备;软管;植入物(外科);使用说明书;加标签;作标记;医疗器械;医疗设备;医疗仪器;医学科学;医疗技术学;神经病学;包装件;质量控制;规范(验收);规范;无菌设备;外科学;外科植入物;用户信息;阀门
【英文主题词】:Dataofthemanufacturer;Definitions;Designations;Englishlanguage;Enterprises;Equipmentforsingleuse;Hoses;Implants(surgical);Instructionsforuse;Labelling(process);Marking;Medicaldevices;Medicalequipment;Medicalinstruments;Medicalsciences;Medicaltechnology;Neurology;Packages;Qualitycontrol;Specification(approval);Specifications;Sterileequipment;Surgery;Surgicalimplants;Userinformation;Valves
【摘要】:ThisInternationalStandardspecifiessafetyandperformancerequirementsforsterile,single-usenon-activehydrocephalusshuntsandcomponents.Thisincludesthecomponentsusedinshunts,likevalves,tubesandreservoirs.ThisInternationalStandardgivesnorecommendationconcerningthesuperiorityofacertaintypeofvalve.Formanufacturing,itdefinesthemechanicalandtechnicalrequirements.ThisInternationalStandarddefinesthetechnicalinformationofthevalve,tobegivenbythemanufacturer.Inrespecttothedifferentprinciplesofthevalvetypes,specificcharacteristicsaredefinedforeachgroupasdeclaredbythemanufacturer.ThebenefitofthisInternationalStandardforthesurgeonandthepatientistounderstandtheinformationgivenbythemanufacturerandtoobtainstandardizedinformationabouttheperformanceofawellworkingproductwithnewdesigncharacteristics.Thebenefitforthemanufactureristodefinetheimportantrequirementsforshuntsasabasisforinvestigationsduringdevelopmentaswellasforqualitycontrolduringmanufacture.ThisInternationalStandarddoesnotapplytoactiveimplantsforthetreatmentofhydrocephalus.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:14P.;A4
【正文语种】:英语
【原文标准名称】:神经外科植入物.无菌、一次性使用的脑积水分流管和组件(ISO7197-2006,包括技术勘误1-2007);德文版本ENISO7197-2009
【标准号】:DINENISO7197-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-08
【实施或试行日期】:2009-08-01
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:制造日期;定义;名称与符号;英语;企业;一次性使用设备;软管;植入物(外科);使用说明书;加标签;作标记;医疗器械;医疗设备;医疗仪器;医学科学;医疗技术学;神经病学;包装件;质量控制;规范(验收);规范;无菌设备;外科学;外科植入物;用户信息;阀门
【英文主题词】:Dataofthemanufacturer;Definitions;Designations;Englishlanguage;Enterprises;Equipmentforsingleuse;Hoses;Implants(surgical);Instructionsforuse;Labelling(process);Marking;Medicaldevices;Medicalequipment;Medicalinstruments;Medicalsciences;Medicaltechnology;Neurology;Packages;Qualitycontrol;Specification(approval);Specifications;Sterileequipment;Surgery;Surgicalimplants;Userinformation;Valves
【摘要】:ThisInternationalStandardspecifiessafetyandperformancerequirementsforsterile,single-usenon-activehydrocephalusshuntsandcomponents.Thisincludesthecomponentsusedinshunts,likevalves,tubesandreservoirs.ThisInternationalStandardgivesnorecommendationconcerningthesuperiorityofacertaintypeofvalve.Formanufacturing,itdefinesthemechanicalandtechnicalrequirements.ThisInternationalStandarddefinesthetechnicalinformationofthevalve,tobegivenbythemanufacturer.Inrespecttothedifferentprinciplesofthevalvetypes,specificcharacteristicsaredefinedforeachgroupasdeclaredbythemanufacturer.ThebenefitofthisInternationalStandardforthesurgeonandthepatientistounderstandtheinformationgivenbythemanufacturerandtoobtainstandardizedinformationabouttheperformanceofawellworkingproductwithnewdesigncharacteristics.Thebenefitforthemanufactureristodefinetheimportantrequirementsforshuntsasabasisforinvestigationsduringdevelopmentaswellasforqualitycontrolduringmanufacture.ThisInternationalStandarddoesnotapplytoactiveimplantsforthetreatmentofhydrocephalus.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:14P.;A4
【正文语种】:英语
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