This document provides guidance on the maintenance management of medical devices that are under the supervision of healthcare delivery organizations.
This document is not applicable to:
a) modification, refurbishment or remanufacturing of medical devices;
b) manufacturers that are responsible for installation, testing, maintenance, and servicing on medical devices that they have placed on the market; or
c) implantable or single-use medical devices.
État actuel: Projet
Comité technique: ISO/TC 210 Management de la qualité et aspects généraux correspondants des dispositifs médicaux