【英文标准名称】:Medicaldevices-Applicationofriskmanagementtomedicaldevices(ISO14971:2007,Correctedversion2007-10-01);EnglishversionofDINENISO14971:2009-10
【原文标准名称】:医疗设备.风险管理在医疗设备上的应用(ISO14971:2007,修订版2007-10-01),德文版本ENISO14971:2009
【标准号】:ENISO14971-2009
【标准状态】:现行
【国别】:
【发布日期】:2009-10
【实施或试行日期】:2009-10-01
【发布单位】:欧洲标准学会(EN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:Acceptance;Accessories;Analysis;Applications;Assessment;Biologicalhazards;Characteristics;Checks;Components;Contact;Contexts;Creation;Definitions;Diagnosis;Dottedlines;Energy;Englishlanguage;Environmentalhazards;Establishment;Evaluations;Examination(qualityassurance);Handling;Hazards;Healthhazards;Invitro;In-vitrodiagnostic;Loss;Management;Materials;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Methods;Personalhealth;Personnel;Planning;Production;Properties;Publichealth;Qualifications;Qualitative;Qualitymanagement;Quantitative;Risk;Riskanalysis;Safety;Safetymeasures;Safetytests;Specification(approval);Surveillance(approval);Use
【摘要】:
【中国标准分类号】:C30
【国际标准分类号】:11_040_01;11_120_01
【页数】:93P.;A4
【正文语种】:英语