Norm

NEN-ISO 11249:2018 en

Koper-houdende intra-uteriene voorbehoedsmiddelen - Richtlijn voor het ontwerp, de uitvoering, analyse en interpretatie van klinische studies

106,87 129,31 Incl BTW

Over deze norm

Status Definitief
Aantal pagina's 23
Commissie Condooms
Gepubliceerd op 01-02-2018
Taal Engels
NEN-ISO 11249 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.

Details

ICS-code 11.200
Nederlandse titel Koper-houdende intra-uteriene voorbehoedsmiddelen - Richtlijn voor het ontwerp, de uitvoering, analyse en interpretatie van klinische studies
Engelse titel Copper-bearing intrauterine contraceptive devices - Guidance on the design, execution, analysis and interpretation of clinical studies

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