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医疗器械档案属于医药卫生科学技术档案,是指在医疗器械使用管理工作中从医疗、防疫、科研、教学、生物制品、生产、器材管理、卫生行政管理以及其他各项活动中形成的具有保存价值的各种文字、图表、声像以及其他的不同载体、不同形式的历史记录。医疗器械档案是医疗器械审批、购置、直至报废全生命周期的动态记录,是医疗器械受控性、安全性、可靠性记录的重要法律文件。随着我国医疗卫生事业的迅猛发展,作为医院的重要支柱之
Medical device files are medical and health science and technology files, refers to the use of medical devices in the management of work from the medical, epidemic prevention, research, teaching, biological products, production, equipment management, health administration and other activities formed with the preservation value Various text, graphics, audio and video and other different carriers, different forms of historical records. Medical device archives are the dynamic records of examination, approval and purchase of medical devices until the end of life cycle. They are important legal documents for the recordability, safety and reliability of medical devices. With the rapid development of China’s medical and health undertakings, as an important pillar of the hospital