Title :
An extended notation of FTA for risk assessment of software-intensive medical devices.: Recognition of the risk class before and after the risk control measure
Author :
Sakai, Yoshiki ; Shirasaka, Seiko ; Nishi, Yoshio
Author_Institution :
Eng. Promotion Center, NIHON KOHDEN Corp., Tokyo, Japan
Abstract :
It is difficult to assess the risk of software-intensive medical devices. An extended notation of FTA recognizes the risk class before and after the risk control measure and the software in the system affects the top event of FTA.
Keywords :
biomedical equipment; fault trees; medical computing; risk management; software reliability; system recovery; FTA; risk assessment; risk class; risk control measure; software-intensive medical devices; Hardware; Hazards; Monitoring; Risk management; Software; Software measurement; Systematics; FTA; residual risk; risk assessment; risk class; risk control measure; software architecture; systematic failure;
Conference_Titel :
Software Reliability Engineering Workshops (ISSREW), 2013 IEEE International Symposium on
Conference_Location :
Pasadena, CA
DOI :
10.1109/ISSREW.2013.6688900