ISO 14155-2:2003

Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans

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.

OEN:

ISO

Langue:

English

Code(s) de l'ICS:

11.100.20

Statut:

Annulée

Date de Publication:

2003-05-15

Numéro Standard:

ISO 14155-2:2003