BS EN 50103-1996 有源(包括有源可植入)医疗器械工业用EN29001/EN46001和EN29002和EN46002应用指南
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【英文标准名称】:GuidanceontheapplicationofEN29001andEN46001andofEN29002andEN46002fortheactive(includingactiveimplantable)medicaldeviceindustry
【原文标准名称】:有源(包括有源可植入)医疗器械工业用EN29001/EN46001和EN29002和EN46002应用指南
【标准号】:BSEN50103-1996
【标准状态】:作废
【国别】:英国
【发布日期】:1996-03-15
【实施或试行日期】:1996-03-15
【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】:质量保证体系;医疗设备;外科植入物;包装;医用电气设备;管理;产品设计;交付;过程控制;质量保证;记录品(文献);检验;质量检查;采购;维修;文献;电驱动装置;储存;验证
【英文主题词】:Active;Applications;Definition;Definitions;Deliveryconditions;Electricappliances;Electricalmedicalequipment;Electromedicine;Guidelines;Implants(surgical);Industries;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Production;Qualityassurance;Qualitymanagement;Standards;Terminology
【摘要】:TheguidelinescontainedinthisEuropeanStandardareapplicabletoaQUALITYSYSTEMasspecifiedbyEN29001andEN46001orEN29002andEN46002.ThisEuropeanStandarddoesnotaddto,orotherwisechangetherequirementsofthosestandards,andisnotintendedtobeuseddirectlyintheassessmentofaSUPPLIER'SQUALITYSYSTEM.TheguidelinesprovideconceptsandobjectiveswhichshouldbeconsideredbyaSUPPLIERofACTIVEMEDICALDEVICESwhiledevelopingandmaintaininghisQUALITYSYSTEM.ThisEuropeanStandard:-providesexamplesofhowtomeettherequirements,whilerecognizingthatothermethodswhichachievethesameendsareequallyacceptable;-givesgeneraladviceonhowtomeettherequirements;-drawsattentiontoaspectsofrequirementsthatmaynotbereadilyapparenttothoseunfamiliarwithQUALITYSYSTEMSusedintheACTIVEMEDICALDEVICEindustry.
【中国标准分类号】:C39
【国际标准分类号】:03_120_10;11_040_01
【页数】:24P.;A4
【正文语种】:英语
【原文标准名称】:有源(包括有源可植入)医疗器械工业用EN29001/EN46001和EN29002和EN46002应用指南
【标准号】:BSEN50103-1996
【标准状态】:作废
【国别】:英国
【发布日期】:1996-03-15
【实施或试行日期】:1996-03-15
【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】:质量保证体系;医疗设备;外科植入物;包装;医用电气设备;管理;产品设计;交付;过程控制;质量保证;记录品(文献);检验;质量检查;采购;维修;文献;电驱动装置;储存;验证
【英文主题词】:Active;Applications;Definition;Definitions;Deliveryconditions;Electricappliances;Electricalmedicalequipment;Electromedicine;Guidelines;Implants(surgical);Industries;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Production;Qualityassurance;Qualitymanagement;Standards;Terminology
【摘要】:TheguidelinescontainedinthisEuropeanStandardareapplicabletoaQUALITYSYSTEMasspecifiedbyEN29001andEN46001orEN29002andEN46002.ThisEuropeanStandarddoesnotaddto,orotherwisechangetherequirementsofthosestandards,andisnotintendedtobeuseddirectlyintheassessmentofaSUPPLIER'SQUALITYSYSTEM.TheguidelinesprovideconceptsandobjectiveswhichshouldbeconsideredbyaSUPPLIERofACTIVEMEDICALDEVICESwhiledevelopingandmaintaininghisQUALITYSYSTEM.ThisEuropeanStandard:-providesexamplesofhowtomeettherequirements,whilerecognizingthatothermethodswhichachievethesameendsareequallyacceptable;-givesgeneraladviceonhowtomeettherequirements;-drawsattentiontoaspectsofrequirementsthatmaynotbereadilyapparenttothoseunfamiliarwithQUALITYSYSTEMSusedintheACTIVEMEDICALDEVICEindustry.
【中国标准分类号】:C39
【国际标准分类号】:03_120_10;11_040_01
【页数】:24P.;A4
【正文语种】:英语
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