【英文标准名称】:Medicaldevices-Qualitymanagementsystems-Requirementsforregulatorypurposes(ISO13485:2003);GermanversionENISO13485:2003+AC:2007
【原文标准名称】:医疗装置.质量管理体系.调整要求
【标准号】:DINENISO13485-2007
【标准状态】:作废
【国别】:德国
【发布日期】:2007-10
【实施或试行日期】:
【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】:售后服务;应用;CE标记;消费者与供货者的关系;定义;交付;交货条件;设计;详细规范;开发;文献;电气工程;架设(施工作业);手册;工业;检验;装配;装置;安装;仪器;国际标准;维修;医疗设备;医疗器械;医疗产品;医学科学;组织;工艺管理;采办;产品设计;生产计划;生产;质量;质量评定系统;质量保证;质量保证体系;质量检查;质量控制;质量改进;质量管理;质量要求;卖货商;服务设施;规范;规范(验收);标准;使用;验证
【英文主题词】:After-salesservices;Applications;Auditing;Bearings;CEmarking;Conduits;Consumer-supplierrelations;Corrrections;Customers;Data;Definitions;Delivery;Deliveryconditions;Design;Detailspecification;Developments;Documentations;Editing;Electricalengineering;Erecting(constructionoperation);Establishment;Evaluations;Handbooks;Handling;Industries;Inspection;Installation;Installations;Instruments;Internationalstandards;Maintenance;Medicaldevices;Medicalequipment;Medicalinstruments;Medicalproducts;Medicalsciences;Methods;Organization;Packages;Planning;Preservation;Preventiveactions;Process;Processmanagement;Procurements;Productdesign;Productplanning;Production;Products;Quality;Qualityassessmentsystems;Qualityassurance;Qualityassurancesystems;Qualityauditing;Qualitycontrol;Qualityimprovement;Qualitymanagement;Qualityrequirements;Responsibility;Returncurrent;Sellers;Services;Shipping;Specification;Specification(approval);Standards;Steeringgear;Storage;Surveillance(approval);Testing;Training;Treatment;Use;Verification
【摘要】:1.1GeneralThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganizationneedstodemonstrateitsabilitytoprovidemedicaldevicesandrelatedservicesthatconsistentlymeetcustomerrequirementsandregulatoryrequirementsapplicabletomedicaldevicesandrelatedservices.TheprimaryobjectiveofthisInternationalStandardistofacilitateharmonizedmedicaldeviceregulatoryrequirementsforqualitymanagementsystems.Asaresult,itincludessomeparticularrequirementsformedicaldevicesandexcludessomeoftherequirementsofISO9001thatarenotappropriateasregulatoryrequirements.Becauseoftheseexclusions,organizationswhosequalitymanagementsystemsconformtothisInternationalStandardcannotclaimconformitytoISO9001unlesstheirqualitymanagementsystemsconformtoalitherequirementsofISO9001(seeAnnexB).1.2ApplicationAllrequirementsofthisInternationalStandardarespecifictoorganizationsprovidingmedicaldevices,regardlessofthetypeorsizeoftheorganization.Ifregulatoryrequirementspermitexclusionsofdesignanddevelopmentcontrols(see7.3),thiscanbeusedasajustificationfortheirexclusionfromthequalitymanagementsystem.Theseregulationscanprovidealternativearrangementsthataretobeaddressedinthequalitymanagementsystem.ItistheresponsibilityoftheorganizationtoensurethatclaimsofconformitywiththisInternationalStandardreflectexclusionofdesignanddevelopmentcontrols[see4.2.2a)and7.3].Ifanyrequirement(s)inClause7ofthisInternationalStandardis(are)notapplicableduetothenatureofthemedicaldevice(s)forwhichthequalitymanagementsystemisapplied,theorganizationdoesnotneedtoincludesucharequirement(s)initsqualitymanagementsystem[see4.2.2a)].TheprocessesrequiredbythisInternationalStandard,whichareapplicabletothemedicaldevice(s),butwhicharenotperformedbytheorganization,aretheresponsibilityoftheorganizationandareaccountedforintheorganization'squalitymanagementsystem[see4.1a)].InthisInternationalStandardtheterms"ifappropriate'and"whereappropriate~areusedseveraltimes.Whenarequirementisqualifiedbyeitherofthesephrases,itisdeemedtobe"appropriate"unlesstheorganizationcandocumentajustificationotherwise.Arequirementisconsidered"appropriate'ifitisnecessaryinorderfor--theproducttomeetspecifiedrequirements,and/or--theorganizationtocarryoutcorrectiveaction.
【中国标准分类号】:C30
【国际标准分类号】:03_120_10;11_040_01
【页数】:69P.;A4
【正文语种】:德语


【英文标准名称】:BloodTransfusionMicro-Filters
【原文标准名称】:输血用微量过滤器
【标准号】:ANSI/AAMIBF7-1989
【标准状态】:作废
【国别】:美国
【发布日期】:1989
【实施或试行日期】:
【发布单位】:美国国家标准学会(US-ANSI)
【起草单位】:AAMI
【标准类型】:()
【标准水平】:()
【中文主题词】:输注;过滤器;医疗设备
【英文主题词】:medicalequipment;filters;transfusions
【摘要】:Describessafetyandperformancerequirementsfordisposablemicro-filtersusedfortheremovalofmicroaggregatesfrombloodorbloodproductsduringtransfusion.
【中国标准分类号】:C31
【国际标准分类号】:11_040_20
【页数】:
【正文语种】:英语