Title :
Usability for medical devices
Abstract :
Use errors caused by poor usability of medical devices are a significant hazard. Regulatory authorities are addressing the issue by implementing guidelines and standards to improve usability engineering practices and minimize usability issues. This document introduces usability engineering, gives examples of critical usability hazards on medical devices and details the relevant regulations addressing usability for medical devices for Europe and the USA.
Keywords :
biomedical equipment; error analysis; health care; health hazards; standards; Europe; USA; error analysis; hazard; medical device; regulations; usability engineering; Aerospace engineering; Biomedical engineering; Design engineering; Hardware; Hazards; Humans; Manufacturing; Military aircraft; Stress; Usability;
Conference_Titel :
Product Safety Engineering, 2005 IEEE Symposium on
Print_ISBN :
0-7803-9350-3
DOI :
10.1109/PSES.2005.1529517
