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】:     Medical devices - Application of risk management to medical devices            【原文标准名称】:     医疗器械.医疗器械风险管理的应用            【标准号】:     BS EN ISO 14971-2009            【标准状态】:     现行            【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;Biological hazards;Characteristics;Checks;Components;Contact;Contexts;Creation;Definitions;Diagnosis;Dotted lines;Energy;Environmental hazards;Establishment;Evaluations;Examination (quality assurance);Handling;Hazards;Health hazards;In vitro;In-vitro diagnostic;Loss;Management;Materials;Medical devices;Medical equipment;Medical products;Medical sciences;Medical technology;Methodsersonal healthersonnellanningroductionropertiesublic health;Qualifications;Qualitative;Quality management;Quantitative;Risk;Risk analysis;Safety;Safety measures;Safety tests;Specification (approval);Surveillance (approval);Use【摘要】: This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.The requirements of this International Standard are applicable to all stages of the life-cycle of a medical device.This International Standard does not apply to clinical decision making.This International Standard does not specify acceptable risk levels.This International Standard does not require that the manufacturer have a quality management system inplace. However, risk management can be an integral part of a quality management system.【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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BS EN ISO 14971-2012
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