{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,9,9]],"date-time":"2024-09-09T18:25:36Z","timestamp":1725906336623},"publisher-location":"Cham","reference-count":19,"publisher":"Springer International Publishing","isbn-type":[{"type":"print","value":"9783319631936"},{"type":"electronic","value":"9783319631943"}],"license":[{"start":{"date-parts":[[2017,1,1]],"date-time":"2017-01-01T00:00:00Z","timestamp":1483228800000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.springer.com\/tdm"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2017]]},"DOI":"10.1007\/978-3-319-63194-3_8","type":"book-chapter","created":{"date-parts":[[2017,7,26]],"date-time":"2017-07-26T11:58:43Z","timestamp":1501070323000},"page":"113-128","source":"Crossref","is-referenced-by-count":2,"title":["Demonstrating that Medical Devices Satisfy User Related Safety Requirements"],"prefix":"10.1007","author":[{"given":"Michael D.","family":"Harrison","sequence":"first","affiliation":[]},{"given":"Paolo","family":"Masci","sequence":"additional","affiliation":[]},{"given":"Jose Creissac","family":"Campos","sequence":"additional","affiliation":[]},{"given":"Paul","family":"Curzon","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2017,7,27]]},"reference":[{"key":"8_CR1","doi-asserted-by":"crossref","DOI":"10.1017\/CBO9781139195881","volume-title":"Modeling in Event-B: System and Software Engineering","author":"J-R Abrial","year":"2010","unstructured":"Abrial, J.-R.: Modeling in Event-B: System and Software Engineering. Cambridge University Press, Cambridge (2010)"},{"key":"8_CR2","unstructured":"Arney, D., Jetley, R., Jones, P., Lee, I., Sokolsky, O., Ray, A., Zhang, Y.: Generic infusion pump hazard analysis and safety requirements. Technical report MS-CIS-08-31, University of Pennsylvania, February 2009"},{"key":"8_CR3","doi-asserted-by":"crossref","unstructured":"Campos, J.C., Harrison, M.D.: Interaction engineering using the IVY tool. In: Calvary, G., Graham, T.C.N., Gray, P. (eds.) Proceedings of the ACM SIGCHI Symposium on Engineering Interactive Computing Systems, pp. 35\u201344. ACM Press (2009)","DOI":"10.1145\/1570433.1570442"},{"key":"8_CR4","unstructured":"Cardinal Health Inc.: Alaris GP volumetric pump: directions for use. Technical report, Cardinal Health, 1180 Rolle, Switzerland (2006)"},{"key":"8_CR5","series-title":"Lecture Notes in Computer Science","doi-asserted-by":"publisher","first-page":"359","DOI":"10.1007\/3-540-45657-0_29","volume-title":"Computer Aided Verification","author":"A Cimatti","year":"2002","unstructured":"Cimatti, A., et al.: NuSMV 2: an opensource tool for symbolic model checking. In: Brinksma, E., Larsen, K.G. (eds.) CAV 2002. LNCS, vol. 2404, pp. 359\u2013364. Springer, Heidelberg (2002). doi:\n10.1007\/3-540-45657-0_29"},{"key":"8_CR6","volume-title":"Model Checking","author":"EM Clarke","year":"1999","unstructured":"Clarke, E.M., Grumberg, O., Peled, D.A.: Model Checking. MIT Press, Cambridge (1999)"},{"key":"8_CR7","doi-asserted-by":"crossref","unstructured":"Gelman, G.E., Feigh, K.M., Rushby, J.: Example of a complementary use of model checking and agent-based simulation. In: 2013 IEEE International Conference on Systems, Man, and Cybernetics (SMC), pp. 900\u2013905, October 2013","DOI":"10.1109\/SMC.2013.158"},{"key":"8_CR8","unstructured":"Harrison, M.D., Campos, J.C., Masci, P.: Reusing models and properties in the analysis of similar interactive devices. In: Innovations in Systems and Software Engineering, pp. 1\u201317, April 2013"},{"key":"8_CR9","doi-asserted-by":"crossref","unstructured":"Heitmeyer, J.C., Kirby Jr., J., Labaw, B.: Applying the SRC requirements method to a weapons control panel: an experience report. In: Proceedings of the Second Workshop on Formal Methods in Software Practice (FMSP 1998), pp. 92\u2013102 (1998)","DOI":"10.1145\/298595.298863"},{"key":"8_CR10","series-title":"Lecture Notes in Computer Science","doi-asserted-by":"publisher","first-page":"40","DOI":"10.1007\/978-3-540-45236-2_4","volume-title":"FME 2003: Formal Methods","author":"GJ Holzmann","year":"2003","unstructured":"Holzmann, G.J.: Trends in software verification. In: Araki, K., Gnesi, S., Mandrioli, D. (eds.) FME 2003. LNCS, vol. 2805, pp. 40\u201350. Springer, Heidelberg (2003). doi:\n10.1007\/978-3-540-45236-2_4"},{"issue":"4","key":"8_CR11","doi-asserted-by":"crossref","first-page":"61","DOI":"10.1109\/MC.2006.113","volume":"39","author":"R Jetley","year":"2006","unstructured":"Jetley, R., Purushothaman Iyer, S., Jones, P.L.: A formal methods approach to medical device review. Computer 39(4), 61\u201367 (2006)","journal-title":"Computer"},{"key":"8_CR12","volume-title":"Engineering a Safer World: Systems Thinking Applied to Safety (Engineering Systems)","author":"NG Leveson","year":"2011","unstructured":"Leveson, N.G.: Engineering a Safer World: Systems Thinking Applied to Safety (Engineering Systems). MIT Press, Cambridge (2011)"},{"key":"8_CR13","doi-asserted-by":"crossref","unstructured":"Masci, P., Ayoub, A., Curzon, P., Harrison, M.D., Lee, I., Sokolsky, O., Thimbleby, H.: Verification of interactive software for medical devices: PCA infusion pumps and FDA regulation as an example. In: Proceedings ACM Symposium Engineering Interactive Systems (EICS 2013), pp. 81\u201390. ACM Press (2013)","DOI":"10.1145\/2494603.2480302"},{"key":"8_CR14","series-title":"Lecture Notes in Computer Science","doi-asserted-by":"publisher","first-page":"228","DOI":"10.1007\/978-3-642-40793-2_21","volume-title":"Computer Safety, Reliability, and Security","author":"P Masci","year":"2013","unstructured":"Masci, P., Ayoub, A., Curzon, P., Lee, I., Sokolsky, O., Thimbleby, H.: Model-based development of the generic PCA infusion pump user interface prototype in PVS. In: Bitsch, F., Guiochet, J., Ka\u00e2niche, M. (eds.) SAFECOMP 2013. LNCS, vol. 8153, pp. 228\u2013240. Springer, Heidelberg (2013). doi:\n10.1007\/978-3-642-40793-2_21"},{"key":"8_CR15","series-title":"Lecture Notes in Computer Science","doi-asserted-by":"publisher","first-page":"200","DOI":"10.1007\/978-3-642-54804-8_14","volume-title":"Fundamental Approaches to Software Engineering","author":"P Masci","year":"2014","unstructured":"Masci, P., Zhang, Y., Jones, P., Curzon, P., Thimbleby, H.: Formal Verification of Medical Device User Interfaces Using PVS. In: Gnesi, S., Rensink, A. (eds.) FASE 2014. LNCS, vol. 8411, pp. 200\u2013214. Springer, Heidelberg (2014). doi:\n10.1007\/978-3-642-54804-8_14"},{"key":"8_CR16","series-title":"OpenAccess Series in Informatics (OASIcs)","first-page":"1","volume-title":"5th Workshop on Medical Cyber-Physical Systems","author":"P Masci","year":"2014","unstructured":"Masci, P., Zhang, Y., Jones, P., Thimbleby, H., Curzon, P.: A generic user interface architecture for analyzing use hazards in infusion pump software. In: Turau, V., Kwiatkowska, M., Mangharam, R., Weyer, C. (eds.) 5th Workshop on Medical Cyber-Physical Systems. OpenAccess Series in Informatics (OASIcs), vol. 36, pp. 1\u201314. Schloss Dagstuhl-Leibniz-Zentrum fuer Informatik, Dagstuhl (2014)"},{"key":"8_CR17","doi-asserted-by":"crossref","unstructured":"Murugesan, A., Whalen, M.W., Rayadurgam, S., Heimdahl, M.P.E.: Compositional verification of a medical device system. In: Proceedings ACM High Integrity Language Technologies (HILT 2013). ACM Press (2013)","DOI":"10.1145\/2527269.2527272"},{"key":"8_CR18","series-title":"Lecture Notes in Computer Science","doi-asserted-by":"publisher","first-page":"748","DOI":"10.1007\/3-540-55602-8_217","volume-title":"Automated Deduction\u2014CADE-11","author":"S Owre","year":"1992","unstructured":"Owre, S., Rushby, J.M., Shankar, N.: PVS: a prototype verification system. In: Kapur, D. (ed.) CADE 1992. LNCS, vol. 607, pp. 748\u2013752. Springer, Heidelberg (1992). doi:\n10.1007\/3-540-55602-8_217"},{"key":"8_CR19","unstructured":"US Food and Drug Administration: General principles of software validation; final guidance for industry and FDA staff. Technical report, Center for Devices and Radiological Health, January 2002. \nhttp:\/\/www.fda.gov\/medicaldevices\/deviceregulationandguidance"}],"container-title":["Lecture Notes in Computer Science","Software Engineering in Health Care"],"original-title":[],"link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/978-3-319-63194-3_8","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2017,7,26]],"date-time":"2017-07-26T12:01:10Z","timestamp":1501070470000},"score":1,"resource":{"primary":{"URL":"http:\/\/link.springer.com\/10.1007\/978-3-319-63194-3_8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017]]},"ISBN":["9783319631936","9783319631943"],"references-count":19,"URL":"https:\/\/doi.org\/10.1007\/978-3-319-63194-3_8","relation":{},"ISSN":["0302-9743","1611-3349"],"issn-type":[{"type":"print","value":"0302-9743"},{"type":"electronic","value":"1611-3349"}],"subject":[],"published":{"date-parts":[[2017]]}}}