BS EN ISO 14971-2009 医疗器械.医疗器械风险管理的应用
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【英文标准名称】:Medicaldevices-Applicationofriskmanagementtomedicaldevices
【原文标准名称】:医疗器械.医疗器械风险管理的应用
【标准号】:BSENISO14971-2009
【标准状态】:作废
【国别】:英国
【发布日期】:2009-07-31
【实施或试行日期】:2009-07-31
【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】:验收;附件;分析;应用;评定;生物危害;特征;检查;元部件;触点;上下文;创作;定义(术语);诊断;虚线;能量;环境危险;设置;评估;检验(质量保证);加工;危害;危害健康;在体外;实验室条件下诊断;损失;管理;材料;医疗器械;医疗设备;医疗产品;医学科学;医疗技术学;方法;个人保健;全体人员;计划;生产;特性;公共卫生;合格;合格的;质量管理;定量的;风险;风险分析;安全性;安全措施;安全试验;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】:C37
【国际标准分类号】:11_040_01
【页数】:96P.;A4
【正文语种】:英语
【原文标准名称】:医疗器械.医疗器械风险管理的应用
【标准号】:BSENISO14971-2009
【标准状态】:作废
【国别】:英国
【发布日期】:2009-07-31
【实施或试行日期】:2009-07-31
【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】:验收;附件;分析;应用;评定;生物危害;特征;检查;元部件;触点;上下文;创作;定义(术语);诊断;虚线;能量;环境危险;设置;评估;检验(质量保证);加工;危害;危害健康;在体外;实验室条件下诊断;损失;管理;材料;医疗器械;医疗设备;医疗产品;医学科学;医疗技术学;方法;个人保健;全体人员;计划;生产;特性;公共卫生;合格;合格的;质量管理;定量的;风险;风险分析;安全性;安全措施;安全试验;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】:C37
【国际标准分类号】:11_040_01
【页数】:96P.;A4
【正文语种】:英语
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