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DIN EN ISO 14971

DIN EN ISO 14971 defines process-related requirements for medical device manufacturers to identify the hazards associated with medical devices, including products for in vitro diagnostics (IVD).

Standard DIN EN ISO 14971 is used to assess and evaluate associated risks in order to manage them and to monitor the effectiveness of risk management actions. The requirements of this international standard apply to all phases of a medical device’s life cycle.
Glossary Technical terms at a glance

C

CAPA Characteristic CIP Coaching Complaint Management Complexity Conformity Considered unit Context diagram Correlation CPK CQRMP Critical characteristic Customer operation Cyber-physical systems

D

Decomposing functions Design FMEA Design of Experiments Detection action Diagnostic coverage DIN EN ISO 14971 DMAIC Dormant failure DRBFM

E

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