ISO 11249:2026
ISO 11249:2026 Copper-bearing intrauterine contraceptive devices — Guidance on the design, execution, analysis and interpretation of clinical studies
CDN $251.00
This publication was last reviewed and confirmed in 2026.
Copper-bearing intrauterine contraceptive devices — Guidance on the design, execution, analysis and interpretation of clinical studies
Description
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.
Edition
2
Published Date
2026-06-19
Status
PUBLISHED
Pages
22
Language
English
Format
Secure PDF
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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.
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