Norm

ISO/DIS 11249:2014 en

Mechanical contraceptives - Guidance for clinical evaluation of intra-uterine contraceptive devices (IUDs)

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Over deze norm

Status Ontwerp
Aantal pagina's 26
Gepubliceerd op 28-07-2014
Taal Engels
This International Standard provides guidance on the design and conduct of clinical studies to determinethe performance characteristics of new intrauterine devices. It also provides advice on the analysisof data when the study is completed, as well as interpretation of these results by manufacturers andregulatory bodies.It is intended to ensure the scientific conduct of the clinical investigation and the credibility of the clinicalinvestigation results, and to assist sponsors, monitors, investigators, ethics committees, regulatoryauthorities and other bodies involved in the conformity assessment of medical devices.Certain clinical trial concerns are not addressed in this guidance document, including subjectcompensation, confidentiality of subjects and their records, use of local ethics committees, etc. Theseand many other clinical trial design issues are covered in great detail in ISO 14155.

Details

ICS-code 11.200
Nederlandse titel Mechanical contraceptives - Guidance for clinical evaluation of intra-uterine contraceptive devices (IUDs)
Engelse titel Mechanical contraceptives - Guidance for clinical evaluation of intra-uterine contraceptive devices (IUDs)

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