ISO 14971-2007 医疗装置.医疗装置风险管理的应用

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【英文标准名称】:Medicaldevices-Applicationofriskmanagementtomedicaldevices
【原文标准名称】:医疗装置.医疗装置风险管理的应用
【标准号】:ISO14971-2007
【标准状态】:现行
【国别】:国际
【发布日期】:2007-03
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC210
【标准类型】:()
【标准水平】:()
【中文主题词】:应用;检查;定义;危害;体外诊断;管理;医疗设备;医疗产品;医学科学;生产;质量管理;风险;风险分析;安全;安全措施;规范(验收);监督(认可);使用
【英文主题词】:Acceptance;Accessories;Analysis;Applications;Assessment;Biologicalhazards;Characteristics;Checks;Components;Contact;Contexts;Creation;Definitions;Diagnosis;Dottedlines;Energy;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】:ThisInternationalStandardspecifiesaprocessforamanufacturertoidentifythehazardsassociatedwithmedicaldevices,includinginvitrodiagnostic(IVD)medicaldevices,toestimateandevaluatetheassociatedrisks,tocontroltheserisks,andtomonitortheeffectivenessofthecontrols.TherequirementsofthisInternationalStandardareapplicabletoallstagesofthelife-cycleofamedicaldevice.ThisInternationalStandarddoesnotapplytoclinicaldecisionmaking.ThisInternationalStandarddoesnotspecifyacceptablerisklevels.ThisInternationalStandarddoesnotrequirethatthemanufacturerhaveaqualitymanagementsysteminplace.However,riskmanagementcanbeanintegralpartofaqualitymanagementsystem.
【中国标准分类号】:C30
【国际标准分类号】:11_040_01
【页数】:82P;A4
【正文语种】:英语