International Standard
ISO 11249:2018
Copper-bearing intrauterine contraceptive devices — Guidance on the design, execution, analysis and interpretation of clinical studies
Reference number
ISO 11249:2018
Edición 1
2018-02
International Standard
Vista previa
ISO 11249:2018
64612
No disponible en español
Publicado (Edición 1, 2018)
Esta norma se revisó y confirmó por última vez en 2023. Por lo tanto, esta versión es la actual.

ISO 11249:2018

ISO 11249:2018
64612
Idioma
Formato
CHF 129
Convertir Franco suizo (CHF) a tu moneda

Resumen

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.

Informaciones generales

  •  : Publicado
     : 2018-02
    : Norma Internacional confirmada [90.93]
  •  : 1
     : 23
  • ISO/TC 157
    11.200 
  • RSS actualizaciones

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)