ISO 29943-2:2017
Current
The latest, up-to-date edition.
Condoms — Guidance on clinical studies — Part 2: Female condoms, clinical function studies based on self-reports
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English
07-06-2017
Important note : All end users must be registered with an Account prior to user licenses being assigned.
ISO 29943-2:2017 is intended to help in the design, execution, analysis, and interpretation of clinical function studies conducted in accordance with the requirements of ISO 25841 for female condoms.
These clinical studies compare the performance of a new female condom to an established female condom during vaginal intercourse (not anal intercourse). In particular, these studies are designed to assess acute failure events during use.
ISO 29943-2:2017 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 29943-2. (07/2017)
|
| DocumentType |
Standard
|
| Pages |
40
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Standards | Relationship |
| IS/ISO 29943 : Part 2 : 2017 | Identical |
| BS ISO 29943-2:2017 | Identical |
| NEN ISO 29943-2 : 2017 | Identical |
| BS ISO 25841:2017 | Female condoms. Requirements and test methods |
| ISO 25841:2017 | Female condoms — Requirements and test methods |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 25841:2017 | Female condoms — Requirements and test methods |
| ISO 16037:2002 | Rubber condoms for clinical trials Measurement of physical properties |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.