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  • BSI
    BS ISO 11249:2018 Copper-bearing intrauterine contraceptive devices. Guidance on the design, execution, analysis and interpretation of clinical studies
    Edition: 2018
    $435.35
    / user per year

Description of BS ISO 11249:2018 2018

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.

It 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.



Standard NumberBS ISO 11249:2018
TitleCopper-bearing intrauterine contraceptive devices. Guidance on the design, execution, analysis and interpretation of clinical studies
StatusUnder Review
Publication Date2018-02-16
Identical National Standard OfISO 11249:2018
DescriptorsIntra-uterine devices, Clinical testing, Birth control, Test methods, Contraceptive devices, Contraceptives, Biological analysis and testing, Pregnancy, Reproductive system, Testing, Contraceptive diaphragms
ICS11.200 Birth control. Mechanical contraceptives
CommitteeCH/157
ISBN978 0 580 86936 5
PublisherBSI
Pages32

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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