ISO/TS 20993:2006Withdrawn

Biological evaluation of medical devices — Guidance on a risk-management process

Évaluation biologique des dispositifs médicaux — Directives relatives à un processus d'évaluation du risque

Abstract / scope

ISO/TS 20993:2006 describes a process by which a manufacturer can identify the biological hazards associated with medical devices, estimate and evaluate the risks, control these risks and monitor the effectiveness of the control.