Methodology for assessing the life cycle processes of scaffolds

Simple item page
dc.citation.epage33
dc.citation.issue2
dc.citation.journalTitleВимірювальна техніка та метрологія
dc.citation.spage26
dc.citation.volume83
dc.contributor.affiliationSumy State University
dc.contributor.affiliationOdesa Polytechnik National University
dc.contributor.authorChernobrovchenko, Vadym
dc.contributor.authorDyadyura, Kostiantyn
dc.coverage.placenameЛьвів
dc.coverage.placenameLviv
dc.date.accessioned2023-05-09T09:19:21Z
dc.date.available2023-05-09T09:19:21Z
dc.date.created2022-02-28
dc.date.issued2022-02-28
dc.description.abstractDue to the increase in diseases in the musculoskeletal system, regenerative medicine is now developing various bone substitutes. Not all scaffolds, due to their shortcomings, are applied for every application. Patients should be provided with basic product information and other warnings about health risks or measures to be taken. From the establishment of the purpose of the biomaterial to apply, several stages of the life cycle can pass. To ensure the biocompatibility of medical devices, there is a legislative framework and standards. They cover the full cycle from testing to market authorization, surveillance, and recall (ISO 15225:2010, ISO/IEC 33001:2015). We have developed the life cycle of bone substitutes and can offer an approach to evaluate operations based on the requirements of the ISO/IEC 33001:2015 series.
dc.format.extent26-33
dc.format.pages8
dc.identifier.citationChernobrovchenko V. Methodology for assessing the life cycle processes of scaffolds / Vadym Chernobrovchenko, Kostiantyn Dyadyura // Measuring equipment and metrology. — Lviv : Lviv Politechnic Publishing House, 2022. — Vol 83. — No 2. — P. 26–33.
dc.identifier.citationenChernobrovchenko V. Methodology for assessing the life cycle processes of scaffolds / Vadym Chernobrovchenko, Kostiantyn Dyadyura // Measuring equipment and metrology. — Lviv : Lviv Politechnic Publishing House, 2022. — Vol 83. — No 2. — P. 26–33.
dc.identifier.doidoi.org/10.23939/istcmtm2022.02.026
dc.identifier.urihttps://ena.lpnu.ua/handle/ntb/59061
dc.language.isoen
dc.publisherВидавництво Львівської політехніки
dc.publisherLviv Politechnic Publishing House
dc.relation.ispartofВимірювальна техніка та метрологія, 2 (83), 2022
dc.relation.ispartofMeasuring equipment and metrology, 2 (83), 2022
dc.relation.references[1] M. Alonzo, F. A. Primo, S. A. Kumar, J. A. Mudloff, E. Dominguez, G. Fregoso, N. Ortiz, Matthew, W. M. Weiss, B. Joddar, “Bone tissue engineering techniques, advances, and scaffolds for treatment of bone defects”, Current opinion in biomedical engineering, 2021, Vol. 17, 100248, DOI: 10.1016/j.cobme.2020.100248.
dc.relation.references[2] G. Fernandez de Grado, L. Keller, Y. Idoux-Gillet, Q. Wagner, A. Musset, N. Benkirane-Jessel, F. Bornert, D. Offner, “Bone substitutes: a review of their characteristics, clinical use, and perspectives for large bone defects management”, Journal of tissue engineering, 1–18, 2018, DOI: 10.1177/2041731418776819.
dc.relation.references[3] V. Campana, G. Milano, E. Pagano, M. Barba, C. Cicione, G. Salonna, V. Lattanzi, G. Lagroscino, “Bone substitutes in orthopedic surgery: from basic science to clinical practice”, Journal of Materials Science: Materials in Medicine, no. 10, 2445–2461, 2014. DOI: 10.1007/s10856-014-5240-2.
dc.relation.references[4] L. R. R. da Silva, W. F. Sales, F. D. A. R. Campos, J. A. G. de Sousa, R. Davis, A. Singh, R. T. Coelho, B. Borgohain, A comprehensive review on additive manufacturing of medical devices, Progress in Additive Manufacturing, no. 3, 517–553, 2021, DOI: 10.1007/s40964-021-00188-0.
dc.relation.references[5] Regulation (EU) 2017/745 of the European Parliament and the Council, EUR-Lex, 2022. [Online]. Available: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745
dc.relation.references[6] Medicines and Medical Devices, European parliament, 2022. [Online]. Available: https://www.europarl.europa.eu/factsheets/en/sheet/50/medicines-and-medical-devices
dc.relation.references[7] ISO 15225:2010 Medical devices – Quality management – Medical device nomenclature data structure, 2010. [Online]. Available: https://www.iso.org/standard/50728.html
dc.relation.references[8] ISO 14971:2007 Medical devices – Application of risk management to medical devices, 2007. [Online]. Available: https://www.iso.org/standard/38193.html
dc.relation.references[9] ISO/IEC 33001:2015 Information technology – Process assessment – Concepts and terminology, 2015. [Online]. Available: https://www.iso.org/standard/54175.html
dc.relation.references[10] ISO/IEC 33020:2015 Information technology – Process assessment – Process measurement framework for assessment of process capability, 2015. [Online]. Available: https://www.iso.org/standard/54195.html
dc.relation.references[11] ISO/IEC 33004:2015 Information technology – Process assessment – Requirements for process reference, process assessment, and maturity models, 2015. [Online]. Available: https://www.iso.org/standard/54178.html
dc.relation.references[12] ISO/IEC 33002:2015 Information technology – Process assessment – Requirements for performing process assessment, 2015. [Online]. Available: https://www.iso.org/standard/54176.html
dc.relation.references[13] V. Chernobrovchenko, K. Diadiura, A. Panda, “Investigation of the blockchain structure for hydroxyapatitebased scaffolds”, Journal of Engineering Sciences, no. 2, 30–35, 2021, DOI: 10.21272/jes.2021.8(2).c5.
dc.relation.references[14] DSTU 3627:2005 Medical devices – Product development and launching into manufacture – basic principles, 2005. [Online]. Available: http://www.ksv.biz.ua/GOST/DSTY_ALL/DSTU1/dstu_3627-2005.pdf.
dc.relation.referencesen[1] M. Alonzo, F. A. Primo, S. A. Kumar, J. A. Mudloff, E. Dominguez, G. Fregoso, N. Ortiz, Matthew, W. M. Weiss, B. Joddar, "Bone tissue engineering techniques, advances, and scaffolds for treatment of bone defects", Current opinion in biomedical engineering, 2021, Vol. 17, 100248, DOI: 10.1016/j.cobme.2020.100248.
dc.relation.referencesen[2] G. Fernandez de Grado, L. Keller, Y. Idoux-Gillet, Q. Wagner, A. Musset, N. Benkirane-Jessel, F. Bornert, D. Offner, "Bone substitutes: a review of their characteristics, clinical use, and perspectives for large bone defects management", Journal of tissue engineering, 1–18, 2018, DOI: 10.1177/2041731418776819.
dc.relation.referencesen[3] V. Campana, G. Milano, E. Pagano, M. Barba, C. Cicione, G. Salonna, V. Lattanzi, G. Lagroscino, "Bone substitutes in orthopedic surgery: from basic science to clinical practice", Journal of Materials Science: Materials in Medicine, no. 10, 2445–2461, 2014. DOI: 10.1007/s10856-014-5240-2.
dc.relation.referencesen[4] L. R. R. da Silva, W. F. Sales, F. D. A. R. Campos, J. A. G. de Sousa, R. Davis, A. Singh, R. T. Coelho, B. Borgohain, A comprehensive review on additive manufacturing of medical devices, Progress in Additive Manufacturing, no. 3, 517–553, 2021, DOI: 10.1007/s40964-021-00188-0.
dc.relation.referencesen[5] Regulation (EU) 2017/745 of the European Parliament and the Council, EUR-Lex, 2022. [Online]. Available: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745
dc.relation.referencesen[6] Medicines and Medical Devices, European parliament, 2022. [Online]. Available: https://www.europarl.europa.eu/factsheets/en/sheet/50/medicines-and-medical-devices
dc.relation.referencesen[7] ISO 15225:2010 Medical devices – Quality management – Medical device nomenclature data structure, 2010. [Online]. Available: https://www.iso.org/standard/50728.html
dc.relation.referencesen[8] ISO 14971:2007 Medical devices – Application of risk management to medical devices, 2007. [Online]. Available: https://www.iso.org/standard/38193.html
dc.relation.referencesen[9] ISO/IEC 33001:2015 Information technology – Process assessment – Concepts and terminology, 2015. [Online]. Available: https://www.iso.org/standard/54175.html
dc.relation.referencesen[10] ISO/IEC 33020:2015 Information technology – Process assessment – Process measurement framework for assessment of process capability, 2015. [Online]. Available: https://www.iso.org/standard/54195.html
dc.relation.referencesen[11] ISO/IEC 33004:2015 Information technology – Process assessment – Requirements for process reference, process assessment, and maturity models, 2015. [Online]. Available: https://www.iso.org/standard/54178.html
dc.relation.referencesen[12] ISO/IEC 33002:2015 Information technology – Process assessment – Requirements for performing process assessment, 2015. [Online]. Available: https://www.iso.org/standard/54176.html
dc.relation.referencesen[13] V. Chernobrovchenko, K. Diadiura, A. Panda, "Investigation of the blockchain structure for hydroxyapatitebased scaffolds", Journal of Engineering Sciences, no. 2, 30–35, 2021, DOI: 10.21272/jes.2021.8(2).P.5.
dc.relation.referencesen[14] DSTU 3627:2005 Medical devices – Product development and launching into manufacture – basic principles, 2005. [Online]. Available: http://www.ksv.biz.ua/GOST/DSTY_ALL/DSTU1/dstu_3627-2005.pdf.
dc.relation.urihttps://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745
dc.relation.urihttps://www.europarl.europa.eu/factsheets/en/sheet/50/medicines-and-medical-devices
dc.relation.urihttps://www.iso.org/standard/50728.html
dc.relation.urihttps://www.iso.org/standard/38193.html
dc.relation.urihttps://www.iso.org/standard/54175.html
dc.relation.urihttps://www.iso.org/standard/54195.html
dc.relation.urihttps://www.iso.org/standard/54178.html
dc.relation.urihttps://www.iso.org/standard/54176.html
dc.relation.urihttp://www.ksv.biz.ua/GOST/DSTY_ALL/DSTU1/dstu_3627-2005.pdf
dc.rights.holder© Національний університет “Львівська політехніка”, 2022
dc.subjectBone substitute
dc.subjectLife cycle
dc.subjectRisk assessment
dc.subjectBiocompatibility
dc.subjectProcess assessment
dc.titleMethodology for assessing the life cycle processes of scaffolds
dc.typeArticle

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Вимірювальна техніка та метрологія. – 2022. – Випуск 83, №2