Norm

ISO/DIS 29943-1:2014 en

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

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Over deze norm

Status Ontwerp
Aantal pagina's 47
Commissie Condooms
Gepubliceerd op 03-03-2014
Taal Engels
This International Standard provides guidance on the design and execution of clinical studies that compare the in-use performance characteristics of new test condoms to those of established male condoms made of natural rubber latex. In particular, these function studies are designed to assess slippage and breakage during use, key performance attributes generally accepted to correlate with condom effectiveness. These trials are intended to evaluate the performance of new condoms during vaginal intercourse (not anal intercourse). This International Standard 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 International Standard, 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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