Clinical investigation of medical devices for human subjects — Good clinical practice
1.Scope范围
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.
本文件阐述了在人类受试者中进行临床研究时，在设计、实施、记录和报告时应遵守的良好临床实践，以评估医疗器械的临床性能或有效性和安全性。
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).
对于上市后的临床研究，考虑到临床研究的性质，应尽可能遵循本文件相关的原则（见附件I）。
This document specifies general requirements intended to
本文件规定了一般性要求，旨在：
— protect the rights, safety and well-being of human subjects,
保护人类受试者的权利、安全和福祉，
— ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,
确保临床研究按科学性要求进行，以及临床研究结果的可信度，
— define the responsibilities of the sponsor and principal investigator, and
明确申办者和主要研究者的职责，以及
— assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
协助申办者、研究者、伦理委员会、监管机构，以及其他参与医疗器械符合性评估的机构。
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.
注1：本文件的用户需要考虑其他标准和/或国家要求是否也适用于正在进行的研究器械或临床研究。如果在要求上存在差异，则采用最严格的。
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.
注2：对于涉及分析有效性（SaMD输出对于给定输入是准确的），以及在适当时，涉及科学有效性（SaMD输出与预期临床状态/生理状态相关时）和临床性能（SaMD输出与目标使用有临床意义的关联）的医用软件（SaMD），本文件的要求尽可能采用（见参考[4]）。当受试者和医用软件的间接接触具有独特性时，可考虑豁免执行该文件要求。
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.
本文件不适用于体外诊断试剂。但是，根据器械和国家或地区的要求，可能存在某些情况，本文件的用户可能会考虑是否采用本文件的特定章节和/或要求。
全文见【金山文档】 ISO 14155-2020（翻译）
https://kdocs.cn/l/cp8Xr0apFt6E
1.Scope范围
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.
本文件阐述了在人类受试者中进行临床研究时，在设计、实施、记录和报告时应遵守的良好临床实践，以评估医疗器械的临床性能或有效性和安全性。
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).
对于上市后的临床研究，考虑到临床研究的性质，应尽可能遵循本文件相关的原则（见附件I）。
This document specifies general requirements intended to
本文件规定了一般性要求，旨在：
— protect the rights, safety and well-being of human subjects,
保护人类受试者的权利、安全和福祉，
— ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,
确保临床研究按科学性要求进行，以及临床研究结果的可信度，
— define the responsibilities of the sponsor and principal investigator, and
明确申办者和主要研究者的职责，以及
— assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
协助申办者、研究者、伦理委员会、监管机构，以及其他参与医疗器械符合性评估的机构。
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.
注1：本文件的用户需要考虑其他标准和/或国家要求是否也适用于正在进行的研究器械或临床研究。如果在要求上存在差异，则采用最严格的。
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.
注2：对于涉及分析有效性（SaMD输出对于给定输入是准确的），以及在适当时，涉及科学有效性（SaMD输出与预期临床状态/生理状态相关时）和临床性能（SaMD输出与目标使用有临床意义的关联）的医用软件（SaMD），本文件的要求尽可能采用（见参考[4]）。当受试者和医用软件的间接接触具有独特性时，可考虑豁免执行该文件要求。
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.
本文件不适用于体外诊断试剂。但是，根据器械和国家或地区的要求，可能存在某些情况，本文件的用户可能会考虑是否采用本文件的特定章节和/或要求。
全文见【金山文档】 ISO 14155-2020（翻译）
https://kdocs.cn/l/cp8Xr0apFt6E
