在用医疗器械产品质量监管初探
재용의료기계산품질량감관초탐
Primary Exploration of the Product Quality Supervision on Medical Devices in Use
  • 万方数据
    中国医疗器械杂志 중국의료기계잡지
    CHINESE JOURNAL OF MEDICAL INSTRUMENTATION
    2014年 3期 207-209 ,共3页

    张欣涛%郝擎%石现%朱炯%李文

    장흔도%학경%석현%주형%리문

    在用医疗器械%质量%监管 在用醫療器械%質量%鑑管
    재용의료기계%질량%감관
    medical devices in use%quality%supervision
    该文围绕在用医疗器械产品质量监管所亟需明确的生命周期、监管边界、监管对象、监管重点、监管依据、执行标准等问题逐一分析，并提出明确且开创性的学术主张，为在用医疗器械产品质量监管做出有益的理论探索。
    해문위요재용의료기계산품질량감관소극수명학적생명주기、감관변계、감관대상、감관중점、감관의거、집행표준등문제축일분석，병제출명학차개창성적학술주장，위재용의료기계산품질량감관주출유익적이론탐색。
    This paper focuses on issues needed to be clear towards the product quality supervision of medical devices in use. The life circle of medical devices, the supervision regarding its boundary, target, emphasis, basis and standards have been analyzed in turn. A clear and creative idea is also provided for theoretical exploration of the supervision on medical devices in use.
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