ISO 11249:2018为确定新型宫内节育器性能特征的临床研究的设计和实施提供了指导。它还为研究完成后的数据分析提供建议，以及制造商、研究人员和监管机构对这些结果的解释。 ISO 11249:2018旨在确保临床调查的科学进行和临床调查结果的可信度，并协助发起人、监督员、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。 本文件未涉及某些临床试验问题，包括受试者报酬、受试者及其记录的保密性、当地伦理委员会的使用等。 ISO 14155详细介绍了这些和许多其他临床试验设计问题。

ISO 11249:2018 provides guidance on the design and conduct of clinical studies to determine the performance characteristics of new intrauterine devices. It also provides advice on the analysis of data when the study is completed, as well as interpretation of these results by manufacturers, researchers and regulatory bodies. ISO 11249:2018 is intended to ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, and to assist sponsors, monitors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices. Certain clinical trial concerns are not addressed in this document, including subject compensation, confidentiality of subjects and their records, use of local ethics committees, etc. These and many other clinical trial design issues are covered in great detail in ISO 14155.