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ISO 13485医疗器材平治系统-特别要求使用ISO9001标准、以及美国医疗器材品系统规范是目前最为完善之医疗器械设计、制造与服务品质保证标准。ISO13485由ISO/TC210医疗器械的自己量管理和通用要求技术委员会制定的，包含了生产质量管理GMP的所有原则，只能与ISO9001结合使用，而不是一个独立的标准。出口到都周的各项医疗器械及设备必须满足偶工体医疗类指令93/42/EEC的要求。实施ISO13485体系可视为满足指令93/42/EEC的要求条件之一。 ISO13485 Medical devices is the most integ rated standard of designing and manufactu ring of medical devices and gua ranteeing service，especial applied to ISO 9001 and Quality System Regulation，(QSA/GMP)．ISO13485 was developed by Quality Management of medical devices and technical committee of universal requirements．consisted of all c riteria of GMPS not a“stand alone”document and must contain IS09001． Medical devices exported to Eu rope must meet the requi rements of direction of EU 93/42/EEC Implementing ISO13485 can be regarded as one of the choice to meet the direction 93/42/EEC． |
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