GSO ISO 29943-1:2021

Condoms — Guidance on clinical studies — Part 1: Male condoms, clinical function studies based on self-reports

GSO ISO 29943-1:2021 发布历史

GSO ISO 29943-1:2021由GSO 发布于 2021-07-01。

GSO ISO 29943-1:2021在国际标准分类中归属于: 11.200 人口控制、避孕器具。

GSO ISO 29943-1:2021 的最新版本是哪一版？

最新版本是 GSO ISO 29943-1:2021 。

GSO ISO 29943-1:2021的历代版本如下：

• 2021年 GSO ISO 29943-1:2021

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.

标准号

GSO ISO 29943-1:2021

发布

2021年

发布单位

GSO

当前最新

GSO ISO 29943-1:2021

 

 

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