Norm

NEN-ISO 29943-1:2017 en

Condooms - Richtlijn voor klinische studies - Deel 1: Mannelijke condooms, klinische functie studies gebaseerd op eigen verslagen

143,10

Over deze norm

Status Definitief
Aantal pagina's 42
Commissie Condooms
Gepubliceerd op 01-07-2017
Taal Engels
NEN-ISO 29943-1 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). This document 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.

Details

ICS-code 11.200
Nederlandse titel Condooms - Richtlijn voor klinische studies - Deel 1: Mannelijke condooms, klinische functie studies gebaseerd op eigen verslagen
Engelse titel Condoms - Guidance on clinical studies - Part 1: Male condoms, clinical function studies based on self-reports

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