ISO 29943-1:2017 - $185.00   BUY NOW

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

ISO 29943-1:2017 Publication Description:

ISO 29943-1:2017 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).

ISO 29943-1:2017 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 ISO 14155.

International Classification for Standards (ICS)

ICS Classification Field ICS Field Sub-Group and Number
ICS-11-Health ICS Birth Control (11.200)

ICS Related Standards

Cart Document Number Document Title
$45.00 ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties
$19.00 ISO 16037/Amd1:2011 Rubber condoms for clinical trials - Measurement of physical properties - Amendment 1
$68.00 ISO 16038:2005 Rubber condoms - Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms
$185.00 ISO 23409:2011 Male condoms - Requirements and test methods for condoms made from synthetic materials
$185.00 ISO 25841:2014 Female condoms - Requirements and test methods
$68.00 ISO 29941:2010 Condoms - Determination of nitrosamines migrating from natural rubber latex condoms
$162.00 ISO 29942:2011 Prophylactic dams - Requirements and test methods
$209.00 ISO 4074:2015 Natural rubber latex male condoms - Requirements and test methods
$240.00 ISO 4074:2014 Natural rubber latex male condoms - Requirements and test methods
$199.00 ISO 4074:2002 Natural latex rubber condoms - Requirements and test methods
$68.00 ISO 7439:2015 Copper-bearing contraceptive intrauterine devices - Requirements and tests
$88.00 ISO 7439:2011 Copper-bearing contraceptive intrauterine devices - Requirements and tests
$138.00 ISO 8009:2014 Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms - Requirements and tests
$149.00 ISO 8009:2004 Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms - Requirements and tests
$22.00 ISO 8009/Amd1:2012 Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms - Requirements and tests - Amendment 1
$209.00 ISO 25841:2017 Female condoms - Requirements and test methods
$185.00 ISO 29943-2:2017 Condoms - Guidance on clinical studies - Part 2: Female condoms, clinical function studies based on self-reports