Condoms. Guidance on clinical studies Male condoms, clinical function studies based on self-reports

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

07-12-2017

Publisher

British Standards Institution

This document is intended to help in the design, execution, analysis and interpretation of clinical function studies conducted in accordance with the requirements of ISO23409 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 ISO14155 .

Committee	CH/157
DevelopmentNote	Supersedes 14/30296392 DC. (07/2017)
DocumentType	Standard
Pages	52
PublisherName	British Standards Institution
Status	Current
Supersedes	14/30296392 DC : 0

Standards	Relationship
ISO 29943-1:2017	Identical

ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
ISO 16037:2002	Rubber condoms for clinical trials Measurement of physical properties
ISO 23409:2011	Male condoms Requirements and test methods for condoms made from synthetic materials
ISO 4074:2015	Natural rubber latex male condoms Requirements and test methods
ISO 14155:2011	Clinical investigation of medical devices for human subjects Good clinical practice