本文件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，以评估医疗器械的临床性能或有效性和安全性。交叉引用:ISO 13485:2016ISO 10993（所有部分）ISO 15223-1购买本文件时可获得的所有现行修订均包含在购买本文件中。

This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.Cross References:ISO 13485:2016ISO 10993 (all parts)ISO 15223-1All current amendments available at time of purchase are included with the purchase of this document.