SSH EN ISO 14155-2:2004

Ekzaminimi klinik i pajisjeve mjekësore për subjektet njerëzore - Pjesa 2: Përgatitjet e ekzaminimit klinik

Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)

Scope

This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation.
This Standard does not apply to in vitro diagnostic medical devices.

Related directives

Directives related to this standards.