GSO ISO 29943-2:2021
避孕套临床研究指南 第2部分：女用避孕套 基于自我报告的临床功能研究

Condoms — Guidance on clinical studies — Part 2: Female condoms, clinical function studies based on self-reports

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标准号

GSO ISO 29943-2:2021

发布

2021年

发布单位

GSO

当前最新

GSO ISO 29943-2:2021

 

 

适用范围

ISO 29943-2:2017 is intended to help in the design, execution, analysis, and interpretation of clinical function studies conducted in accordance with the requirements of ISO 25841 for female condoms. These clinical studies compare the performance of a new female condom to an established female condom during vaginal intercourse (not anal intercourse). In particular, these studies are designed to assess acute failure events during use. ISO 29943-2:2017 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.

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