ISO 29943-1:2017 PDF

Scope: This document 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.

ISO 29943-1:2017 Referenced Document

ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms*， 2024-04-20 Update
ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
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

2017 ISO 29943-1:2017 Condoms - Guidance on clinical studies - Part 1: Male condoms, clinical function studies based on self-reports