Utilize este identificador para referenciar este registo:
https://hdl.handle.net/1822/51320
Título: | A hazard analysis method for systematic identification of safety requirements for user interface software in medical devices |
Autor(es): | Masci, Paolo Zhang, Yi Jones, Paul Campos, José C. |
Palavras-chave: | Medical devices Requirements identification/formalization User interface software |
Data: | 1-Jan-2017 |
Editora: | Springer Verlag |
Revista: | Lecture Notes in Computer Science (including subseries Lecture Notes in Artificial Intelligence and Lecture Notes in Bioinformatics) |
Resumo(s): | © Springer International Publishing AG (outside the US) 2017. Formal methods technologies have the potential to verify the usability and safety of user interface (UI) software design in medical devices, enabling significant reductions in use errors and consequential safety incidents with such devices. This however depends on comprehensive and verifiable safety requirements to leverage these techniques for detecting and preventing flaws in UI software that can induce use errors. This paper presents a hazard analysis method that extends Leveson’s System Theoretic Process Analysis (STPA) with a comprehensive set of causal factor categories, so as to provide developers with clear guidelines for systematic identification of use-related hazards associated with medical devices, their causes embedded in UI software design, and safety requirements for mitigating such hazards. The method is evaluated with a case study on the Gantry-2 radiation therapy system, which demonstrates that (1) as compared to standard STPA, our method allowed us to identify more UI software design issues likely to cause use-related hazards; and (2) the identified UI software design issues facilitated the definition of precise, verifiable safety requirements for UI software, which could be readily formalized in verification tools such as Prototype Verification System (PVS). |
Tipo: | Artigo em ata de conferência |
URI: | https://hdl.handle.net/1822/51320 |
ISBN: | 9783319661964 |
DOI: | 10.1007/978-3-319-66197-1_18 |
ISSN: | 0302-9743 |
Arbitragem científica: | yes |
Acesso: | Acesso aberto |
Aparece nas coleções: |
Ficheiros deste registo:
Ficheiro | Descrição | Tamanho | Formato | |
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MasciZJC17-SEFM-postprint.pdf | 498,82 kB | Adobe PDF | Ver/Abrir |