Title :
Risk management standards and IEC 60601-1
Abstract :
This presentation dealt with: risk management standards such as 1st, 2nd and 3rd edition ISO 14971, and IEC 60601-1-4; risk analysis; hazard identification; risk evaluation; risk control; post production; management responsibilities; equivalent safety; fault; PEMS; and other related topics.
Keywords :
IEC standards; ISO standards; measurement standards; risk analysis; 1st edition ISO 14971; 2nd edition ISO 14971; 3rd edition ISO 14971; IEC 60601-1; IEC 60601-1-4; PEMS; equivalent safety; fault; hazard identification; management responsibilities; post production; risk analysis; risk control; risk evaluation; risk management standards;
Conference_Titel :
Medical Device Standards & Regulations - All Change, 2005. MDSRAC. IEE Seminar on
Conference_Location :
London
DOI :
10.1049/ic.2005.0778
