EN ISO 14971:2000 RISK MANAGEMENT FOR MEDICAL DEVICES

EN ISO 14971:2000 – risk management for medical devices includes risk analysis, evaluation, control and post production information.
Do not confuse with EN ISO 14971-1:1998 which is replaced by this standard.
The risk analysis element of EN 1441 is retained within the new standard.
    

Risk Assessment	RISK ANALYSIS Intended Use Hazard Identification Risk Estimation	Risk Management
	RISK EVALUATION Acceptability Decisions
	RISK CONTROL Options Analysis Implementation Residual risk evaluation & acceptance
	POST PRODUCTION INFORMATION Post-production Experience Review of Risk Man Experience   All recorded in the
	RISK MANAGEMENT FILE

THE EN ISO 14971 PROCESS IS CONTINUOUS

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