ISO 29943-1:2017

Indisponible en français

Publiée (Edition 1, 2017)

Cette norme a été révisée et confirmée pour la dernière fois en 2023. Cette édition reste donc d’actualité.

ISO 29943-1:2017

CHF 173

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Résumé

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.

Informations générales

État actuel
: Publiée

Date de publication
: 2017-07

Stade
: Norme internationale confirmée [90.93]
Edition
: 1
Comité technique :
ISO/TC 157

ICS :
11.200
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