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【英文标准名称】:Medicaldevices-Qualitymanagementsystems-Requirementsforregulatorypurposes
【原文标准名称】:医疗设备.质量管理体系.管理用系统要求
【标准号】:ANSI/AAMI/ISO13485-2003
【标准状态】:现行
【国别】:美国
【发布日期】:2003
【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】:ANSI
【标准类型】:()
【标准水平】:()
【中文主题词】:售后服务;应用;审计;CE标记;导(线)管;消费者与供货者的关系;修正;顾客;数据;定义;交付;交货条件;设计;详细规范;开发;文献工作;编辑;电气工程;架设(施工作业);设置;评定;手册;搬运;工业;检验;装配;装置;仪器;国际标准;维修;医疗器械;医疗设备;医疗装置;医疗产品;医学科学;方法;组织;包装件;计划;保存;预防作用;过程;工艺管理;采办;产品设计;产品规划;生产;产品;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;质量要求;可靠性;卖货商;服务设施;航运;规范;规范(验收);标准;转向机构;储存;监督(认可);试验;训练;处理;使用;验证
【英文主题词】:After-salesservices;Applications;Auditing;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;Qualityrequirements;Responsibility;Sellers;Services;Shipping;Specification;Specification(approval);Standards;Steeringgear;Storage;Surveillance(approval);Testing;Training;Treatment;Use;Verification
【摘要】:Specifiesrequirementsforaqualitymanagementsystemwhereanorganizationneedstodemonstrateitsabilitytoprovidemedicaldevicesthatconsistentlymeetcustomerrequirementsandregulatoryrequirementsapplicabletomedicaldevices.
【中国标准分类号】:C00
【国际标准分类号】:11_040_01
【页数】:
【正文语种】:英语


Product Code:SAE AMS3702
Title:Epoxy Resin, Tetraglycidyl Methylenedianiline 14,000 - 18,000centipoise Viscosity (Cancelled Oct 1995)
Issuing Committee:Ams P17 Composite Materials Committee
Scope: