Résumé
PrévisualiserISO 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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État actuel: PubliéeDate de publication: 2017-07
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Edition: 1
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Comité technique: ISO/TC 157 Contraceptifs non systémiques et barrière prophylactique contre les IST
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- ICS :
- 11.200 Contrôle des naissances. Contraceptifs mécaniques
Acheter cette norme
| Format | Langue | |
|---|---|---|
| std 1 166 | PDF + ePub | |
| std 2 166 | Papier |
- CHF166
Cycle de vie
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Actuellement
PubliéeISO 29943-1:2017
Les normes ISO sont réexaminées tous les cinq ans
Stade: 90.60 (En cours d'examen)
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