Applying Risk Management Principles to Medical Devices Performance Assurance Program—Defining the Process

Tidimogo Gaamangwe Agustina Krivoy and Petr Kresta

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Applying Risk Management Principles to Medical Devices Performance Assurance Program—Defining the Process

机译：将风险管理原则应用于医疗器械性能保证计划—定义流程

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The management of medical devices entails a number of essential components. These include technology assessment, acquisition, inventory control, repair service, in-service education, performance assurance (PA), etc. The PA program, in some cases referred to as preventive maintenance (PM), deals with device operation, performance, and safety. In this paper, PM is regarded as a specific subcomponent or activity of the PA program.

机译：医疗设备的管理需要许多基本组件。其中包括技术评估，采购，库存控制，维修服务，在职培训，性能保证（PA）等。PA程序在某些情况下称为预防性维护（PM），涉及设备的运行，性能和维护。安全。在本文中，PM被视为PA程序的特定子组件或活动。

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来源
《Biomedical Instrumentation & Technology》 |2008年第5期|p.401-406|共6页
作者
Tidimogo Gaamangwe Agustina Krivoy and Petr Kresta;
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作者单位

Tidimogo Gaamangwe MSc, PEng, is a clinical engineer at Health Sciences Center in Winnipeg, Manitoba, Canada. He is a member of ACCE, CMBES, and IEEE.Agustina Krivoy, a member CMBES, is a biomedical engineer (EIT) at Health Sciences Center.Petr Kresta MHSc., PEng, is the technical director of the diagnostic imaging program at Health Sciences Centre and the director of the clinical engineering program for the Winnipeg Regional Healthy Authority, and is a member of ACCE and CMBES. Address correspondence to Mr. Gaamangwe at tgaamangwe@hsc.mb.ca.;

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正文语种 eng
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关键词
Applying Risk Management;

机译：应用风险管理;

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1. Applying Risk Management Principles to Medical Devices Performance Assurance Program-Defining the Process [J] . Tidimogo Gaamangwe, Agustina Krivoy, Petr Kresta Biomedical Instrumentation and Technology . 2008,第5期

机译：将风险管理原则应用于医疗器械性能保证计划-定义流程
2. Guidance for validation and monitoring of thermal cleaning and disinfection processes for medical devices and for general principles of choosing devices as a part of quality assurance conditioning (reprocessing) of medical devices and presentation of improvements in the guidance from October 2008 [J] . Maria Theresia Linner Krankenhaus-Hygiene + Infektionsverhutung . 2009,第3期

机译：验证和监视医疗器械热清洗和消毒过程的指南，以及选择器械作为医疗器械质量保证条件（再处理）的一部分的一般原则，并在2008年10月开始对该指南进行改进
3. Medical Device Risk Management For Performance Assurance Optimization and Prioritization. [J] . Tidimogo Gaamangwe, Vishvek Babbar, Agustina Krivoy, Biomedical Instrumentation and Technology . 2015,第6期

机译：用于性能保证优化和优先级排序的医疗设备风险管理。
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5. Design of Medical Devices Involving Multi-disciplinary Processes and Based on Fundamental Physical Principles. [D] . Krautbauer, Kevin Robert. 2016

机译：基于基本物理原理的涉及多学科过程的医疗设备设计。
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7. Medical Device Risk Management For Performance Assurance Optimization and Prioritization [O] . Tidimogo Gaamangwe, Vishvek Babbar, Agustina Krivoy, 2015

机译：用于性能保证优化和优先级的医疗器械风险管理

Applying Risk Management Principles to Medical Devices Performance Assurance Program—Defining the Process

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