标准编号：ISO 29943-1:2017
中文名称：避孕套 临床研究指南 第1部分：男性避孕套、基于自我报告的临床功能研究
英文名称：Condoms — Guidance on clinical studies — Part 1: Male condoms, clinical function studies based on self-reports
发布日期：2017-07
标准范围
This document 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). This document 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.
立即下载标准文件