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How the MHRA regulates the safety of devices

机译:MHRA如何规范设备安全

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摘要

The term "medical device" covers any product,other than medicines,that is used in the health care environment for the diagnosis,treatment,prevention or monitoring of illness or disease.It encompasses a wide variety of products,ranging from blood pressure monitors,aids for the disabled and needles and syringes,to pacemakers,coronary stents,heart valves,joint replacements and equipment used in vitro for the examination of specimens,including blood and tissue donations derived from the human body for the purpose of diagnosis or monitoring (eg,blood glucose monitors,cholesterol tests,pregnancy tests).
机译:「医疗装置」一词涵盖医疗环境中用于诊断,治疗,预防或监测疾病的任何产品,但不包括药物。它涵盖了多种产品,包括血压计,用于残疾人和针头和注射器的辅助工具,用于起搏器,冠状动脉支架,心脏瓣膜,关节置换和体外用于检查标本的设备,包括为诊断或监测目的从人体获得的血液和组织捐赠,血糖监测仪,胆固醇测试,怀孕测试)。

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