ANSI/AAMI/ISO 14155:2011
人体用医疗器械的临床研究 临床试验质量管理规范

Clinical investigation of medical devices for human subjects - Good clinical practice

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标准号

ANSI/AAMI/ISO 14155:2011

发布

2010年

发布单位

US-AAMI

替代标准

ANSI/AAMI/ISO 14155:2020

当前最新

ANSI/AAMI/ISO 14155:2020

 

 

适用范围

This International Standard 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 this International Standard 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. This International Standard 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. It does not apply to in vitro diagnostic medical devices.

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