【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.管理要求
【标准号】:BSENISO13485-2012
【标准状态】:现行
【国别】:英国
【发布日期】:2012-03-31
【实施或试行日期】:2012-03-31
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:After-salesservices;Applications;Auditing;CEmarking;Conduits;Consumer-supplierrelations;Corrrections;Customers;Data;Definitions;Delivery;Deliveryconditions;Design;Detailspecification;Developments;Documentation;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;Returncurrent;Sellers;Services;Shipping;Specification;Specification(approval);Standards;Steeringgear;Storage;Surveillance(approval);Testing;Training;Treatment;Use;Verification
【摘要】:
【中国标准分类号】:C00;C30
【国际标准分类号】:03_120_10;11_040_01
【页数】:86P;A4
【正文语种】:英语