Standardization of in vitro testing for cardiovascular implants in the era of European Medical Device Regulation

In case of cardiovascular implants classified as class III medical products there is a specific responsibility for manufacturers as well as regulatory authorities to follow international standards to guarantee for safety and efficacy. Fast developments of science and technology as well as novel clin...

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Autores principales:	Schmidt Wolfram, Brandt-Wunderlich Christoph, Stiehm Michael, Kaule Sebastian, Siewert Stefan, Bock Andrea, Schmitz Klaus-Peter, Kurzhals Anja, Grabow Niels
Formato:	article
Lenguaje:	EN
Publicado:	De Gruyter 2020
Materias:	vascular stents artificial heart valves in-vitro testing standardization medical device regulation Medicine R
Acceso en línea:	https://doaj.org/article/d9823466539044679c00eb19724397cc
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spelling	oai:doaj.org-article:d9823466539044679c00eb19724397cc2021-12-05T14:10:42ZStandardization of in vitro testing for cardiovascular implants in the era of European Medical Device Regulation2364-550410.1515/cdbme-2020-3085https://doaj.org/article/d9823466539044679c00eb19724397cc2020-09-01T00:00:00Zhttps://doi.org/10.1515/cdbme-2020-3085https://doaj.org/toc/2364-5504In case of cardiovascular implants classified as class III medical products there is a specific responsibility for manufacturers as well as regulatory authorities to follow international standards to guarantee for safety and efficacy. Fast developments of science and technology as well as novel clinical findings create permanent needs to match the standardization. Therefore, a set of international standards is analyzed with respect to their use for particular coronary drug-eluting stents and artificial heart valves. It was found that standards (ISO, ASTM) exist for general requirements on passive implants, but also specifically relate to arterial stents, stent grafts, bioresorbable and drug-eluting stents, as well as artificial heart valves. New work items address new methods for characterization of coating integrity, particulate matter and simulated use testing. European Medical Device Regulation (MDR) requires technical expertise and capacity at Notified Bodies supported by independent test laboratories. Generally, the interest in standardization from industry, test laboratories and authorities is high, but more input from medical experts would further improve the value of standardization and its relevance for safe and even more effective implants.Schmidt WolframBrandt-Wunderlich ChristophStiehm MichaelKaule SebastianSiewert StefanBock AndreaSchmitz Klaus-PeterKurzhals AnjaGrabow NielsDe Gruyterarticlevascular stentsartificial heart valvesin-vitro testingstandardizationmedical device regulationMedicineRENCurrent Directions in Biomedical Engineering, Vol 6, Iss 3, Pp 330-333 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	vascular stents artificial heart valves in-vitro testing standardization medical device regulation Medicine R
spellingShingle	vascular stents artificial heart valves in-vitro testing standardization medical device regulation Medicine R Schmidt Wolfram Brandt-Wunderlich Christoph Stiehm Michael Kaule Sebastian Siewert Stefan Bock Andrea Schmitz Klaus-Peter Kurzhals Anja Grabow Niels Standardization of in vitro testing for cardiovascular implants in the era of European Medical Device Regulation
description	In case of cardiovascular implants classified as class III medical products there is a specific responsibility for manufacturers as well as regulatory authorities to follow international standards to guarantee for safety and efficacy. Fast developments of science and technology as well as novel clinical findings create permanent needs to match the standardization. Therefore, a set of international standards is analyzed with respect to their use for particular coronary drug-eluting stents and artificial heart valves. It was found that standards (ISO, ASTM) exist for general requirements on passive implants, but also specifically relate to arterial stents, stent grafts, bioresorbable and drug-eluting stents, as well as artificial heart valves. New work items address new methods for characterization of coating integrity, particulate matter and simulated use testing. European Medical Device Regulation (MDR) requires technical expertise and capacity at Notified Bodies supported by independent test laboratories. Generally, the interest in standardization from industry, test laboratories and authorities is high, but more input from medical experts would further improve the value of standardization and its relevance for safe and even more effective implants.
format	article
author	Schmidt Wolfram Brandt-Wunderlich Christoph Stiehm Michael Kaule Sebastian Siewert Stefan Bock Andrea Schmitz Klaus-Peter Kurzhals Anja Grabow Niels
author_facet	Schmidt Wolfram Brandt-Wunderlich Christoph Stiehm Michael Kaule Sebastian Siewert Stefan Bock Andrea Schmitz Klaus-Peter Kurzhals Anja Grabow Niels
author_sort	Schmidt Wolfram
title	Standardization of in vitro testing for cardiovascular implants in the era of European Medical Device Regulation
title_short	Standardization of in vitro testing for cardiovascular implants in the era of European Medical Device Regulation
title_full	Standardization of in vitro testing for cardiovascular implants in the era of European Medical Device Regulation
title_fullStr	Standardization of in vitro testing for cardiovascular implants in the era of European Medical Device Regulation
title_full_unstemmed	Standardization of in vitro testing for cardiovascular implants in the era of European Medical Device Regulation
title_sort	standardization of in vitro testing for cardiovascular implants in the era of european medical device regulation
publisher	De Gruyter
publishDate	2020
url	https://doaj.org/article/d9823466539044679c00eb19724397cc
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Standardization of in vitro testing for cardiovascular implants in the era of European Medical Device Regulation

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