本文件定义了为评估体外诊断（IVD）医疗器械的临床性能和安全性而进行的临床性能研究的规划、设计、实施、记录和报告的良好研究实践，以达到监管目的。 注1:这些研究的目的是评估预期用户手中的IVD医疗设备在预期人群中产生特定医疗条件或生理/病理状态相关结果的能力。 本文件并非旨在说明临床性能研究是否充分解决了相关IVD医疗器械的技术规格问题。 本文件确定了支持临床绩效研究的原则，并规定了旨在 -确保临床表现研究的开展将导致可靠和稳健的研究结果，-定义赞助者和主要研究者的责任，BR> -协助赞助商、临床研究机构、调查人员、伦理委员会、监管机构和其他参与IVD医疗器械合格评定的机构，并保护提供用于临床性能研究的样本的受试者的权利、安全、尊严和福祉。 分析性能研究不在本文件范围内。 注2:如果专门为分析性能研究收集样本会给受试者带来额外的收集风险，则本文件的一些内容（尤其是附件）可用于确保受试者的安全。 出于上市前和上市后监管目的以外的原因进行的临床绩效研究（如用于再支付目的）不在本文件的范围内。 注3:本文件的一些要素对此类研究的设计非常有用，包括受试者安全性和数据完整性。 本文件不包括实验室工作人员或收集研究样本的其他人员的安全信息。 注4此类信息包含在其他出版物[1][12][13]中。 注释5本文件的使用者可以考虑是否其他的标准和/或要求也适用于作为临床表现研究的主题的IVD医疗设备，例如，在IVD医疗设备和用于集成系统中的医疗设备（如刺血针、IVD测试条和血糖仪）的情况下，可以考虑本文件和ISO 14155的各个方面。交叉引用:ISO/IEC指南51:2014ISO 16142-2:2017ISO 15193:2009ISO 18113-1:2009ISO 15190:2003ISO 14971ISO 14155ISO/TR 24971ISO 13131:2014ISO 13485购买本文件时提供的所有当前修订版均包含在购买本文件中。

This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes. NOTE 1 The purpose of these studies is to assess the ability of an IVD medical device in the hands of the intended user, to yield results pertaining to a particular medical condition or physiological/pathological state, in the intended population. The document is not intended to describe whether the technical specifications of the IVD medical device in question are adequately addressed by the clinical performance study. This document identifies the principles that underpin clinical performance studies and specifies general requirements intended to — ensure the conduct of the clinical performance study will lead to reliable and robust study results,— define the responsibilities of the sponsor and principal investigator,BR> — assist sponsors, clinical research organization, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of IVD medical devices, and— protect the rights, safety, dignity and well-being of the subjects providing specimens for use in clinical performance studies. Analytical performance studies are out of the scope of this document. NOTE 2 When the collection of specimens specifically for the analytical performance study creates an additional collection risk for subjects, some of the elements of this document (particularly the annexes) can be useful for ensuring subject safety. Clinical performance studies that are performed for reasons other than pre- and post-market regulatory purposes, such as for re-imbursement purposes, are out of the scope of this document. NOTE 3 Some of the elements of this document can be useful for the design of such studies, including subject safety and data integrity. This document does not include safety information for laboratory workers or other personnel collecting the study specimens. NOTE 4 Such information is included in other publications[1][12][13]. NOTE 5 Users of this document can consider whether other standards and/or requirements also apply to the IVD medical device which is the subject of the clinical performance study, for instance, in the situation for which there is an IVD medical device and a medical device used in an integrated system (e.g. a lancet, an IVD test strip, and a glucose meter), aspects of both this document and ISO 14155 can be considered.Cross References:ISO/IEC Guide 51:2014ISO 16142-2:2017ISO 15193:2009ISO 18113-1:2009ISO 15190:2003ISO 14971ISO 14155ISO/TR 24971ISO 13131:2014ISO 13485All current amendments available at time of purchase are included with the purchase of this document.