标准摘要
[中文适用范围]： 本文件旨在帮助设计、执行、分析和解释根据 ISO 23409 男用合成避孕套的要求进行的临床功能研究。 这些临床研究比较了新的男用避孕套与现有的男用避孕套在阴道性交（非肛交）期间的性能。 特别是，这些研究旨在评估使用过程中的急性失效事件（即临床滑移和临床破损）。 本文件还提供了研究完成后数据分析的指导，以及制造商和监管机构对这些结果的解释。 本文件未涉及某些临床试验要素，包括补偿、个人及其记录的保密性、当地伦理委员会的使用等。 ISO 14155 中更详细地介绍了这些以及许多其他临床试验设计问题。 [外文原描述]： ISO 29943-1:2017 is intended to help in the design, execution, analysis and interpretation of clinical function studies conducted in accordance with the requirements of ISO 23409 for male synthetic condoms. These clinical studies compare the performance of a new male condom to an established male condom during vaginal intercourse (not anal intercourse). In particular, these studies are designed to assess acute failure events during use (i.e. clinical slippage and clinical breakage). ISO 29943-1:2017 also provides direction on the analysis of data when the study is completed, as well as interpretation of these results by manufacturers and regulatory bodies. Certain clinical trial elements are not addressed in this document, including compensation, confidentiality of individuals and their records, use of local ethics committees, etc. These and many other clinical trial design issues are covered in greater detail in ISO 14155.
英文名称Condoms — Guidance on clinical studies — Part 1: Male condoms, clinical function studies based on self-reports