Norm

ISO 14155:2020 en

Klinisch onderzoek van medische hulpmiddelen voor gebruik bij mensen - Goede klinische praktijkrichtlijnen (GCP)

182,40 198,82 Incl BTW

Over deze norm

Status Definitief
Aantal pagina's 83
Commissie Klinisch onderzoek
Gepubliceerd op 01-07-2020
Taal Engels
ISO 14155 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I).This document specifies general requirements intended to- protect the rights, safety and well-being of human subjects,- ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,- define the responsibilities of the sponsor and principal investigator, and- assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

Details

ICS-code 11.100.20
Nederlandse titel Klinisch onderzoek van medische hulpmiddelen voor gebruik bij mensen - Goede klinische praktijkrichtlijnen (GCP)
Engelse titel Clinical investigation of medical devices for human subjects - Good clinical practice
Vervangt

Winkelwagen

Subtotaal:

Ga naar winkelwagen