Condoms -- Guidance on clinical studies -- Part 2: Female condoms, clinical function studies based on self-reports
Status:
Valid
Buy this standard
StandardISO standard
·
ISO 29943-2:2017
Condoms -- Guidance on clinical studies -- Part 2: Female condoms, clinical function studies based on self-reports
Subscribe on standards with our subscription service. When you use our service you can be assured the latest editions and easy access.
Read more about SIS Subscriptions
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.
Condoms -- Guidance on clinical studies -- Part 2: Female condoms, clinical function studies based on self-reports
Subscribe on standards with our subscription service. When you use our service you can be assured the latest editions and easy access.
Read more about SIS Subscriptions
