ISO 11249:2026
Current
The latest, up-to-date edition.
Copper-bearing intrauterine contraceptive devices — Guidance on the design, execution, analysis and interpretation of clinical studies
Hardcopy , PDF
English
12-05-2026
This document provides guidance on the design and conduct of clinical studies to determine the performance characteristics of new intrauterine devices. It also provides advice on the analysis of data when the study is completed, as well as interpretation of these results by manufacturers, researchers and regulatory bodies.
Certain clinical trial concerns are not addressed in this document, including participant compensation, confidentiality of participants and their records, use of local ethics committees, etc. These and many other clinical trial design issues are covered in great detail in ISO14155.
| Committee |
ISO/TC 157
|
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
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