Wallace, D.
and Kuhn, D.
(1999),
Software Quality Lessons From Medical Device Failure Data, - 6407, National Institute of Standards and Technology, Gaithersburg, MD
(Accessed January 24, 2025)
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Software Quality Lessons From Medical Device Failure Data
Published
Author(s)
,
Abstract
Most complex systems today contain software, and systems failures activated by software faults can provide lessons for software development practices and software quality assurance. This report presents an analysis of 342 software-related failures of medical devices that caused no death or injury but led to recalls by the manufacturers. The analysis categorizes the failures by their symptoms and faults. Tables provide methods for preventing and detecting the faults. The nature of the faults provides lessons about the value of generally accepted quality practices for prevention and detection methods applied prior to system release. It also provides some insight into the need for formal requirements specification and for improved testing of complex hardware-software systems.Citation
- 6407
Report Number
6407
Pub Type
NIST Pubs
Keywords
high assurance, medical devices, quality practices, software faults, system failures
Citation
Issues
If you have any questions about this publication or are having problems accessing it, please contact reflib@nist.gov.
Created November 1, 1999, Updated October 16, 2008