BS ISO 29943-1:2017
Current
The latest, up-to-date edition.
Condoms. Guidance on clinical studies Male condoms, clinical function studies based on self-reports
Hardcopy , PDF
English
12-07-2017
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
CH/157
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| DevelopmentNote |
Supersedes 14/30296392 DC. (07/2017)
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| DocumentType |
Standard
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| Pages |
52
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| PublisherName |
British Standards Institution
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| Status |
Current
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| Supersedes |
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 .
| 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 |
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