Demonstrating that medical devices satisfy user related safety requirements

Detalhes bibliográficos
Autor(a) principal: Harrison, Michael douglas
Data de Publicação: 2017
Outros Autores: Masci, Paolo, Campos, José C., Curzon, Paul
Idioma: eng
Título da fonte: Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)
Texto Completo: http://hdl.handle.net/1822/51329
Resumo: One way of contributing to a demonstration that a medical device is acceptably safe is to show that the device satisfies a set of requirements known to mitigate hazards. This paper describes experience using formal techniques to model an IV infusion device and to prove that the modelled device captures a set of requirements. The requirements chosen for the study are based on a draft proposal developed by the US Food and Drug Administration (FDA). A major contributor to device related errors are (user) interaction errors. For this reason the chosen models and requirements focus on user interface related issues.
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spelling Demonstrating that medical devices satisfy user related safety requirementsFormal verificationHuman errorMALMedical devicesModel checkingPerformancePVSTheorem provingScience & TechnologyOne way of contributing to a demonstration that a medical device is acceptably safe is to show that the device satisfies a set of requirements known to mitigate hazards. This paper describes experience using formal techniques to model an IV infusion device and to prove that the modelled device captures a set of requirements. The requirements chosen for the study are based on a draft proposal developed by the US Food and Drug Administration (FDA). A major contributor to device related errors are (user) interaction errors. For this reason the chosen models and requirements focus on user interface related issues.FEDER - Federación Española de Enfermedades Raras(000062)This work has been funded by the EPSRC research grant EP/G059063/1: CHI+MED (Computer–Human Interaction for Medical Devices). J. C. Campos was funded by project NORTE-07-0124-FEDER-000062Springer International Publishing AGUniversidade do MinhoHarrison, Michael douglasMasci, PaoloCampos, José C.Curzon, Paul20172017-01-01T00:00:00Zconference paperinfo:eu-repo/semantics/publishedVersionapplication/pdfhttp://hdl.handle.net/1822/51329eng97833196319360302-974310.1007/978-3-319-63194-3_8info:eu-repo/semantics/openAccessreponame:Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)instname:FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologiainstacron:RCAAP2024-05-11T07:03:26Zoai:repositorium.sdum.uminho.pt:1822/51329Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireinfo@rcaap.ptopendoar:https://opendoar.ac.uk/repository/71602025-05-28T16:13:54.648008Repositórios Científicos de Acesso Aberto de Portugal (RCAAP) - FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologiafalse
dc.title.none.fl_str_mv Demonstrating that medical devices satisfy user related safety requirements
title Demonstrating that medical devices satisfy user related safety requirements
spellingShingle Demonstrating that medical devices satisfy user related safety requirements
Harrison, Michael douglas
Formal verification
Human error
MAL
Medical devices
Model checking
Performance
PVS
Theorem proving
Science & Technology
title_short Demonstrating that medical devices satisfy user related safety requirements
title_full Demonstrating that medical devices satisfy user related safety requirements
title_fullStr Demonstrating that medical devices satisfy user related safety requirements
title_full_unstemmed Demonstrating that medical devices satisfy user related safety requirements
title_sort Demonstrating that medical devices satisfy user related safety requirements
author Harrison, Michael douglas
author_facet Harrison, Michael douglas
Masci, Paolo
Campos, José C.
Curzon, Paul
author_role author
author2 Masci, Paolo
Campos, José C.
Curzon, Paul
author2_role author
author
author
dc.contributor.none.fl_str_mv Universidade do Minho
dc.contributor.author.fl_str_mv Harrison, Michael douglas
Masci, Paolo
Campos, José C.
Curzon, Paul
dc.subject.por.fl_str_mv Formal verification
Human error
MAL
Medical devices
Model checking
Performance
PVS
Theorem proving
Science & Technology
topic Formal verification
Human error
MAL
Medical devices
Model checking
Performance
PVS
Theorem proving
Science & Technology
description One way of contributing to a demonstration that a medical device is acceptably safe is to show that the device satisfies a set of requirements known to mitigate hazards. This paper describes experience using formal techniques to model an IV infusion device and to prove that the modelled device captures a set of requirements. The requirements chosen for the study are based on a draft proposal developed by the US Food and Drug Administration (FDA). A major contributor to device related errors are (user) interaction errors. For this reason the chosen models and requirements focus on user interface related issues.
publishDate 2017
dc.date.none.fl_str_mv 2017
2017-01-01T00:00:00Z
dc.type.driver.fl_str_mv conference paper
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/1822/51329
url http://hdl.handle.net/1822/51329
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 9783319631936
0302-9743
10.1007/978-3-319-63194-3_8
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Springer International Publishing AG
publisher.none.fl_str_mv Springer International Publishing AG
dc.source.none.fl_str_mv reponame:Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)
instname:FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologia
instacron:RCAAP
instname_str FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologia
instacron_str RCAAP
institution RCAAP
reponame_str Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)
collection Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)
repository.name.fl_str_mv Repositórios Científicos de Acesso Aberto de Portugal (RCAAP) - FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologia
repository.mail.fl_str_mv info@rcaap.pt
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