Reference number
ISO 11249:2018
© ISO 2024
International Standard
ISO 11249:2018
Copper-bearing intrauterine contraceptive devices — Guidance on the design, execution, analysis and interpretation of clinical studies
Edition 1
2018-02
Read sample
Published (Edition 1, 2018)
This publication was last reviewed and confirmed in 2023. Therefore this version remains current.

ISO 11249:2018

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CHF 129
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Abstract

ISO 11249:2018 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.

ISO 11249:2018 is intended to ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, and to assist sponsors, monitors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

Certain clinical trial concerns are not addressed in this document, including subject compensation, confidentiality of subjects 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
     : 2018-02
    Stage
    : International Standard to be revised [90.92]
  • Edition
     : 1
    Number of pages
     : 23
  • 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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