ISO 29943-1:2017
Current
The latest, up-to-date edition.
Condoms — Guidance on clinical studies — Part 1: Male condoms, clinical function studies based on self-reports
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English
07-06-2017
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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.
| Committee |
ISO/TC 157
|
| DevelopmentNote |
Supersedes ISO/DIS 29943-1. (07/2017)
|
| DocumentType |
Standard
|
| Pages |
42
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Standards | Relationship |
| BS ISO 29943-1:2017 | Identical |
| NEN ISO 29943-1 : 2017 | Identical |
| IS/ISO 29943 : Part 1 : 2017 | Identical |
| ISO 16038:2017 | Male condoms — Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms |
| BS ISO 23409:2011 | Male condoms. Requirements and test methods for condoms made from synthetic materials |
| ISO 23409:2011 | Male condoms Requirements and test methods for condoms made from synthetic materials |
| BS ISO 16038:2017 | Male condoms. Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms |
| 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 |
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