{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,9,8]],"date-time":"2024-09-08T20:58:06Z","timestamp":1725829086856},"publisher-location":"Cham","reference-count":22,"publisher":"Springer International Publishing","isbn-type":[{"type":"print","value":"9783319242545"},{"type":"electronic","value":"9783319242552"}],"license":[{"start":{"date-parts":[[2015,1,1]],"date-time":"2015-01-01T00:00:00Z","timestamp":1420070400000},"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":[[2015]]},"DOI":"10.1007\/978-3-319-24255-2_14","type":"book-chapter","created":{"date-parts":[[2015,9,5]],"date-time":"2015-09-05T09:51:13Z","timestamp":1441446673000},"page":"183-196","source":"Crossref","is-referenced-by-count":1,"title":["Safety Case Driven Development for Medical Devices"],"prefix":"10.1007","author":[{"given":"Alejandra","family":"Ruiz","sequence":"first","affiliation":[]},{"given":"Paulo","family":"Barbosa","sequence":"additional","affiliation":[]},{"given":"Yang","family":"Medeiros","sequence":"additional","affiliation":[]},{"given":"Huascar","family":"Espinoza","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2015,11,25]]},"reference":[{"issue":"4","key":"14_CR1","doi-asserted-by":"publisher","first-page":"14","DOI":"10.1109\/MSP.2013.49","volume":"11","author":"A Alemzadeh","year":"2013","unstructured":"Alemzadeh, A., Iyer, R.K., Kalbarczyk, Z., Raman, F.: Analysis of safety-critical computer failures in medical devices. IEEE Secur. Priv. 11(4), 14\u201326 (2013)","journal-title":"IEEE Secur. Priv."},{"key":"14_CR2","unstructured":"MHRA: Report on Devices Adverse Incidents in 2010 (2011). http:\/\/www.mhra.gov.uk\/home\/groups\/dts-bs\/documents\/publication\/con129234.pdf"},{"key":"14_CR3","unstructured":"The Boston Consulting Group: EU Medical Device Approval Safety Assessment: A comparative analysis of medical device recalls 2005\u20132009 (2011). http:\/\/www.eucomed.org\/uploads\/Press%20Releases\/BCG%20study%20report.pdf"},{"issue":"4","key":"14_CR4","doi-asserted-by":"publisher","first-page":"351","DOI":"10.1142\/S021853930100058X","volume":"8","author":"DR Wallace","year":"2001","unstructured":"Wallace, D.R., Kuhn, D.R.: Failure modes in medical device software: an analysis of 15 years of recall data. Int. J. Reliab. Qual. Saf. Eng. 8(4), 351\u2013371 (2001)","journal-title":"Int. J. Reliab. Qual. Saf. Eng."},{"key":"14_CR5","unstructured":"The Health Foundation: Supplements to: Using safety cases in industry and healthcare (2012). http:\/\/www.health.org.uk\/public\/cms\/75\/76\/313\/3847\/Using%20safety%20cases%20in%20industry%20and%20healthcare_supplements.pdf?realName=yjOYNa.pdf"},{"issue":"3","key":"14_CR6","doi-asserted-by":"publisher","first-page":"58","DOI":"10.1109\/MS.2013.60","volume":"30","author":"P M\u00e4der","year":"2013","unstructured":"M\u00e4der, P., Jones, P.L., Zhang, Y., Cleland-Huang, J.: Strategic Traceability for Safety-Critical Projects. IEEE Softw. 30(3), 58\u201366 (2013)","journal-title":"IEEE Softw."},{"key":"14_CR7","unstructured":"Eucomed: Towards a regulation that guarantees patient safety, ensures patient access and keeps innovation in Europe (2013). http:\/\/www.eucomed.org\/uploads\/Modules\/Publications\/20130130_2013_eucomed_detailed_position_on_proposal_mdd_revision.pdf"},{"key":"14_CR8","doi-asserted-by":"crossref","unstructured":"Kelly, T.: Arguing Safety - A Systematic Approach to Managing Safety Cases. Ph.d. thesis, Department of Computer Science, The University of York (1998)","DOI":"10.1007\/3-540-48249-0_2"},{"key":"14_CR9","unstructured":"ISO 26262 International Organization for Standardization (ISO), \u201cISO\/DIS 26262: Road vehicles - functional safety,\u201d (2011)"},{"key":"14_CR10","unstructured":"Bloomfield, R., Chozos, N., Embrey, D., Henderson, J., Kelly, T., Koornneef, F., Pasquini, A., Pozzi, S., Sujan, M.-A.: A Pragmatic Review of the Use of Safety Cases in Industry\u2013Lessons and Prerequisites for their Application in Healthcare (2011)"},{"key":"14_CR11","doi-asserted-by":"crossref","unstructured":"Eagles, S., Wu, F.: Safety Assurance Cases for Medical Devices. In: AAMI 2014, Biomedical Instrumentation & Technology, February 2014","DOI":"10.2345\/0899-8205-48.1.24"},{"key":"14_CR12","unstructured":"GSN Community Standard. Version.: Origin Consulting GSN Community Standard Version 1 (2011)"},{"key":"14_CR13","unstructured":"International Electrotechnical Commission Medical device software \u2013 Software life cycle processes. INTERNATIONAL IEC STANDARD 62304 First edition 2006-05. International Electrotechnical Commission (2006). Accessed 2 June 2012"},{"key":"14_CR14","unstructured":"ISO 14971 - medical devices \u2013 application of risk management to medical devices. Technical report, International Organization for Standardization (2010)"},{"key":"14_CR15","unstructured":"IEC\/TR 80002-1:2009: Medical Device Software Part 1: Guidance on the application of ISO 14971 to medical device software. ISO, Switzerland (2009)"},{"key":"14_CR16","unstructured":"ISO\/IEC 42010 (IEEE Std) 1471-2000: Systems and Software engineering- Recomended practice for architectural description of software-intensive systems, ISO\/IEC\/(IEEE), p. 23"},{"key":"14_CR17","unstructured":"Rick, K., Mark, K., Paul, C: ATAM: Method for Architecture Evaluation, Software Engineering Institute, Carnegie Mellon University, Pittsburgh, Pennsylvania, Technical report CMU\/SEI-2000-TR-004 (2000). http:\/\/resources.sei.cmu.edu\/library\/asset-view.cfm?AssetID=5177"},{"issue":"7","key":"14_CR18","doi-asserted-by":"publisher","first-page":"638","DOI":"10.1109\/TSE.2002.1019479","volume":"28","author":"L Dobrica","year":"2002","unstructured":"Dobrica, L., Niemel\u00e4, E.: A survey on software architecture analysis methods. IEEE Trans. Softw. Eng. 28(7), 638\u2013653 (2002)","journal-title":"IEEE Trans. Softw. Eng."},{"key":"14_CR19","volume-title":"Software Systems Architecture: Working with Stakeholders Using Viewpoints and Perspectives","author":"N Rozanski","year":"2005","unstructured":"Rozanski, N., Woods, E.: Software Systems Architecture: Working with Stakeholders Using Viewpoints and Perspectives. Addison-Wesley Professional, Reading (2005)"},{"key":"14_CR20","unstructured":"Antonino, P., Trapp, M..: Improving consistency checks between safety concepts and view based architecture design. In: Proceedings of 12th International Probabilistic Safety Assessment and Management Conference, PSAM 2014, Honolulu, Hawaii, USA, 22\u201327 June 2014"},{"issue":"2","key":"14_CR21","doi-asserted-by":"publisher","first-page":"103","DOI":"10.1016\/j.annemergmed.2011.07.022","volume":"59","author":"L DeLuca Jr","year":"2012","unstructured":"DeLuca Jr., L., et al.: Analysis of automated external defibrillator device failures reported to the food and drug administration. Annals Emerg. Med. 59(2), 103\u2013111 (2012)","journal-title":"Annals Emerg. Med."},{"key":"14_CR22","doi-asserted-by":"crossref","unstructured":"Knight, J.C.: Safety critical systems: challenges and directions. In: Proceedings of the 24th International Conference on Software Engineering, ICSE 2002, pp. 547\u2013550, 25 May 2002","DOI":"10.1145\/581404.581406"}],"container-title":["Lecture Notes in Computer Science","Computer Safety, Reliability, and Security"],"original-title":[],"link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/978-3-319-24255-2_14","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,5,21]],"date-time":"2022-05-21T09:02:20Z","timestamp":1653123740000},"score":1,"resource":{"primary":{"URL":"http:\/\/link.springer.com\/10.1007\/978-3-319-24255-2_14"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015]]},"ISBN":["9783319242545","9783319242552"],"references-count":22,"URL":"https:\/\/doi.org\/10.1007\/978-3-319-24255-2_14","relation":{},"ISSN":["0302-9743","1611-3349"],"issn-type":[{"type":"print","value":"0302-9743"},{"type":"electronic","value":"1611-3349"}],"subject":[],"published":{"date-parts":[[2015]]}}}