ISO 14155:2011 以人为对象的医疗器械的临床调查 良好临床规程

标准编号：ISO 14155:2011

中文名称：以人为对象的医疗器械的临床调查 良好临床规程

英文名称：Clinical investigation of medical devices for human subjects — Good clinical practice

发布日期：2011-02

标准范围

ISO 14155:2011阐述了在人体受试者中进行临床研究的设计、实施、记录和报告的良好临床实践，以评估医疗器械的安全性或性能，达到监管目的。ISO 14155:2011中规定的原则也适用于所有其他临床研究，应尽可能遵守，具体取决于临床研究的性质和国家法规的要求。ISO 14155:2011规定了旨在保护权利、安全和健康的一般要求-作为人体受试者，确保临床研究的科学性和结果的可信度，确定赞助者和主要研究者的责任，并协助赞助者、研究者、伦理委员会、监管机构和其他参与医疗器械合格评定的机构。ISO 14155:2011不适用于体外诊断医疗设备。

ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.The principles set forth in ISO 14155:2011 also apply to all other clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations.ISO 14155:2011 specifies general requirements intended to protect the rights, safety and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.ISO 14155:2011 does not apply to in vitro diagnostic medical devices.

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