How to assure correctness and safety of medical software: The hemodialysis machine case study

Autoren Paolo Arcaini
Silvia Bonfanti
Angelo Gargantini
Elvinia Riccobene
Editoren Michael Butler
Klaus-Dieter Schewe
Atif Mashkoor
Miklós Biró
TitelHow to assure correctness and safety of medical software: The hemodialysis machine case study
BuchtitelAbstract State Machines, Alloy, B, TLA, VDM, and Z - Proc. ABZ 2016
Typin Konferenzband
VerlagSpringer
SerieLecture Notes in Computer Science
Band9676
ISBN978-3-319-33599-5
DOI10.1007/978-3-319-33600-8_30
MonatMay
Jahr2016
Seiten344-359
SCCH ID#1648
Abstract

Medical devices are nowadays more and more software dependent, and software malfunctioning can lead to injuries or death for patients. Several standards have been proposed for the development and the validation of medical devices, but they establish general guidelines on the use of common software engineering activities without any indication regarding methods and techniques to assure safety and reliability.

This paper takes advantage of the Hemodialysis machine case study to present a formal development process supporting most of the engineering activities required by the standards, and provides rigorous approaches for system validation and verification. The process is based on the Abstract State Machine formal method and its model refinement principle.