DocumentCode
2030399
Title
The assessment and control of risk in the development of medical systems
Author
Bibb ; , B.R.M.
Author_Institution
Philips Med. Syst.-Radiotherapy, Crawley, UK
fYear
1994
fDate
1994
Firstpage
42430
Lastpage
42433
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;
fLanguage
English
Publisher
iet
Conference_Titel
Designing Safety-Critical Systems, IEE Colloquium on
Conference_Location
IET
Type
conf
Filename
1638580
Link To Document