International Standard
ISO 11249:2026
Copper-bearing intrauterine contraceptive devices — Guidance on the design, execution, analysis and interpretation of clinical studies
Reference number
ISO 11249:2026
Edition 2
2026-05
© ISO 2026
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Published (Edition 2, 2026)

ISO 11249:2026

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Abstract

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 ISO 14155.

General information

  • Status
     : Published
    Publication date
     : 2026-05
    Stage
    : International Standard published [60.60]
  • Edition
     : 2
    Number of pages
     : 22
  • Technical Committee :
    ISO/TC 157
    ICS :
    11.200 
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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