Title :
The assessment and control of risk in the development of medical systems
Author_Institution :
Philips Med. Syst.-Radiotherapy, Crawley, UK
Abstract :
The inadequacy of the traditional approach to medical device safety assessment for increasingly complex and software-controlled systems is exposed. The process of risk analysis in the draft European standard is presented in flowchart form. A qualitative risk estimation method is adapted from a draft IEC generic standard.
Keywords :
biomedical engineering; health hazards; risk management; standards; IEC; development of medical systems; draft European standard; medical device safety assessment; qualitative risk estimation; risk analysis; software-controlled systems;
Conference_Titel :
Designing Safety-Critical Systems, IEE Colloquium on
Conference_Location :
IET
