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

This International Standard addresses good clinical practice for the design, conduct, recording and reportingof clinical investigations carried out in human subjects to assess the safety or performance of medical devicesfor regulatory purposes.The principles set forth in this International Standard also apply to all other clinical investigations and shouldbe followed as far as possible, considering the nature of the clinical investigation and the requirements ofnational 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 clinical investigationresults,—define the responsibilities of the sponsor and principal investigator, and—assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in theconformity assessment of medical devices.It does not apply to in vitro diagnostic medical devices.NOTE Standards developed by ISO/TC 194 are intended to be applied to medical devices. Users of this InternationalStandard will need to consider whether other standards and/or requirements also apply to the investigational device(s)under consideration.

标准预览图