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ISO 29943-1:2017
Condoms — Guidance on clinical studies — Part 1: Male condoms, clinical function studies based on self-reports
Translate name
STANDARD published on 6.7.2017
The information about the standard:
Designation standards: ISO 29943-1:2017
Publication date standards: 6.7.2017
SKU: NS-687945
The number of pages: 42
Approximate weight : 126 g (0.28 lbs)
Country: International technical standard
Category: Technical standards ISO
The category - similar standards:
Annotation of standard text ISO 29943-1:2017 :
Description / Abstract: 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.
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