ISO-29943-2 › Condoms - Guidance on clinical studies - Part 2: Female condoms, clinical function studies based on self-reports
The following bibliographic material is provided to assist you with your purchasing decision:
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.
To find similar documents by classification:
11.200 (Birth control. Mechanical contraceptives)
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Document Number
ISO 29943-2:2017
Revision Level
1ST EDITION
Status
Current
Publication Date
July 1, 2017
Committee Number
ISO/TC 157