BS EN 724-1995 非放射性医疗器械用EN29001,EN46001,EN29002,EN46002标准的应用导则
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【英文标准名称】:GuidanceontheapplicationofEN29001andEN46001andofEN29002andEN46002fornon-activemedicaldevices
【原文标准名称】:非放射性医疗器械用EN29001,EN46001,EN29002,EN46002标准的应用导则
【标准号】:BSEN724-1995
【标准状态】:作废
【国别】:英国
【发布日期】:1995-04-15
【实施或试行日期】:1995-04-15
【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】:生产;包装;产品设计;工作规范;试验设备;无菌室;训练;作标记;作标记;防护服装;无菌设备;记录品(文献);文献;储存;采购;加标签;清洁处理;质量检查;维修;检验;质量保证;管理;医疗设备;质量保证体系;消费者与供货者的关系
【英文主题词】:Design;Guidebooks;Maintenance;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Production;Quality;Qualityassurance;Qualityassurancesystems;Specification(approval)
【摘要】:ThisEuropeanStandardprovidesguidanceontheestablishmentandmaintenanceofthequalitysystemsspecifiedinEN29001/EN46001orEN29002/EN46002forthemanufactureofnon-activemedicaldevices.Itdoesnotaddto,orotherwisechange,therequirementsofthosestandardsandisnotintendedtobeusedfortheassessmentofamanufacturer'squalitysystem.ThisEuropeanStandardprovidesexamplesofhowtomeettherequirements,recognizingthatothermethodswhichachievethesameendsareequallyacceptable;givesgeneraladviceonhowtomeettherequirements;anddrawsattentiontoaspectsofrequirementsthatmaynotbereadilyapparenttothoseunfamiliarwithqualitysystemsfornon-activemedicaldevices.AnnexAtothisEuropeanStandardprovidesguidanceontheelementsofqualitysystemswhicharerelevanttothemanufactureofmedicaldeviceswhicharetobesuppliedeithersterileoratadefinedlevelofmicrobiologicalorparticulatecleanliness.TheadoptionofsystemsotherthanthosedescribedinthisEuropeanStandardisnottoberegardedasanon-compliancewithEN29001andEN29002and/orthespecificrequirementsinEN46001andEN46002.
【中国标准分类号】:C30
【国际标准分类号】:11_040_01
【页数】:28P;A4
【正文语种】:英语
【原文标准名称】:非放射性医疗器械用EN29001,EN46001,EN29002,EN46002标准的应用导则
【标准号】:BSEN724-1995
【标准状态】:作废
【国别】:英国
【发布日期】:1995-04-15
【实施或试行日期】:1995-04-15
【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】:生产;包装;产品设计;工作规范;试验设备;无菌室;训练;作标记;作标记;防护服装;无菌设备;记录品(文献);文献;储存;采购;加标签;清洁处理;质量检查;维修;检验;质量保证;管理;医疗设备;质量保证体系;消费者与供货者的关系
【英文主题词】:Design;Guidebooks;Maintenance;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Production;Quality;Qualityassurance;Qualityassurancesystems;Specification(approval)
【摘要】:ThisEuropeanStandardprovidesguidanceontheestablishmentandmaintenanceofthequalitysystemsspecifiedinEN29001/EN46001orEN29002/EN46002forthemanufactureofnon-activemedicaldevices.Itdoesnotaddto,orotherwisechange,therequirementsofthosestandardsandisnotintendedtobeusedfortheassessmentofamanufacturer'squalitysystem.ThisEuropeanStandardprovidesexamplesofhowtomeettherequirements,recognizingthatothermethodswhichachievethesameendsareequallyacceptable;givesgeneraladviceonhowtomeettherequirements;anddrawsattentiontoaspectsofrequirementsthatmaynotbereadilyapparenttothoseunfamiliarwithqualitysystemsfornon-activemedicaldevices.AnnexAtothisEuropeanStandardprovidesguidanceontheelementsofqualitysystemswhicharerelevanttothemanufactureofmedicaldeviceswhicharetobesuppliedeithersterileoratadefinedlevelofmicrobiologicalorparticulatecleanliness.TheadoptionofsystemsotherthanthosedescribedinthisEuropeanStandardisnottoberegardedasanon-compliancewithEN29001andEN29002and/orthespecificrequirementsinEN46001andEN46002.
【中国标准分类号】:C30
【国际标准分类号】:11_040_01
【页数】:28P;A4
【正文语种】:英语
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