International Organization for Standardization (ISO)
Status
Latest
ISO/TS 20993:2006
Scope
This Technical Specification 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.
ISO/TS 20993:2006 history
2006ISO/TS 20993:2006 Biological evaluation of medical devices - Guidance on a risk-management process