Reference number
ϲʿ 29943-2:2017
International Standard
ϲʿ 29943-2:2017
Condoms — Guidance on clinical studies — Part 2: Female condoms, clinical function studies based on self-reports
Edition 1
2017-07
Preview
ϲʿ 29943-2:2017
62498
No disponible en 貹ñDZ
Publicado (徱ó 1, 2017)
Esta publicación se revisó y confirmó por última vez en 2023. Por lo tanto, esta versión es la actual.

ϲʿ 29943-2:2017

ϲʿ 29943-2:2017
62498
Idioma
Formato
CHF 173
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Resumen

ϲʿ 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 ϲʿ 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.

ϲʿ 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 ϲʿ 14155.

Informaciones generales

  •  : Publicado
     : 2017-07
    : Norma Internacional confirmada [90.93]
  •  : 1
     : 40
  • ϲʿ/TC 157
    11.200 
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