ISO 14155:2020 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 14155:2020

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：2020-07

标准范围

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。对于上市后临床调查，考虑到临床调查的性质，本文件中规定的原则应尽可能遵守（见附件一）。本文件规定了一般要求，旨在:-保护人类主体的权利、安全和福祉，-确保临床调查的科学开展和临床调查结果的可信度，-明确申办人和主要研究人员的职责，以及-协助赞助商、调查人员、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。注1本文件的使用者需要考虑其他标准和/或国家要求是否也适用于正在考虑的调查设备或临床调查。如果要求存在差异，则适用最严格的要求。注2:对于作为医疗设备的软件（SaMD），SaMD的分析有效性（SaMD的输出对于给定的输入是准确的），以及科学有效性（SaMD的输出与预期的临床条件/生理状态相关）和临床性能（SaMD的输出与目标用途产生临床意义的关联）的证明，本文件的要求尽可能适用（见参考文献[4]）。免除该文件的理由可以考虑主体和SaMD间接接触的独特性。本文件不适用于体外诊断医疗设备。然而，可能存在依赖于设备和国家或区域要求的情况，在此文档中的用户可以考虑该文档的特定部分和/或要求是否适用。

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.For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I).This document 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 investigation 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.NOTE 1 Users of this document need to consider whether other standards and/or national requirements also apply to the investigational device(s) under consideration or the clinical investigation. If differences in requirements exist, the most stringent apply.NOTE 2 For Software as a Medical Device (SaMD) demonstration of the analytical validity (the SaMD's output is accurate for a given input), and where appropriate, the scientific validity (the SaMD's output is associated to the intended clinical condition/physiological state), and clinical performance (the SaMD's output yields a clinically meaningful association to the target use) of the SaMD, the requirements of this document apply as far as relevant (see Reference [4]). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD.This document does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document might consider whether specific sections and/or requirements of this document could be applicable.

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