BS 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).
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.
Cross References:ISO 16037:2002
ISO 13485:2016
ISO 4074:2015
ASTM D7661 - 10
ISO 14155:2011
ISO 23409:2011 Ed 1
All current amendments available at time of purchase are included with the purchase of this document. | File Size : | 1
file
, 8.4 MB |
| ISBN(s) : | 9780580856280 |
| Note : | This product is unavailable in Russia, Ukraine, Belarus |
| Number of Pages : | 50 |
| Product Code(s) : | 30296393, 30296393, 30296393 |
| Published : | 07/12/2017 |
| Same As : | BS ISO 29943-1:2017 |
