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...
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
De Gruyter
2020-09-01
|
| Series: | Current Directions in Biomedical Engineering |
| Subjects: | |
| Online Access: | https://doi.org/10.1515/cdbme-2020-3085 |
| _version_ | 1811246854265896960 |
|---|---|
| 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 |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-04-12T14:59:20Z |
| format | Article |
| id | doaj.art-d9823466539044679c00eb19724397cc |
| institution | Directory Open Access Journal |
| issn | 2364-5504 |
| language | English |
| last_indexed | 2024-04-12T14:59:20Z |
| publishDate | 2020-09-01 |
| publisher | De Gruyter |
| record_format | Article |
| series | Current Directions in Biomedical Engineering |
| spelling | doaj.art-d9823466539044679c00eb19724397cc2022-12-22T03:28:07ZengDe GruyterCurrent Directions in Biomedical Engineering2364-55042020-09-016333033310.1515/cdbme-2020-3085cdbme-2020-3085Standardization of in vitro testing for cardiovascular implants in the era of European Medical Device RegulationSchmidt Wolfram0Brandt-Wunderlich Christoph1Stiehm Michael2Kaule Sebastian3Siewert Stefan4Bock Andrea5Schmitz Klaus-Peter6Kurzhals Anja7Grabow Niels8University Medicine Rostock, Institute for Biomedical Engineering, Friedrich-Barnewitz- Straße 4,Rostock, GermanyInstitute for ImplantTechnology and Biomaterials IIB e.V.,Rostock, GermanyInstitute for ImplantTechnology and Biomaterials IIB e.V.,Rostock, GermanyInstitute for ImplantTechnology and Biomaterials IIB e.V.,Rostock, GermanyInstitute for ImplantTechnology and Biomaterials IIB e.V.,Rostock, GermanyInstitute for ImplantTechnology and Biomaterials IIB e.V.,Rostock, GermanyInstitute for ImplantTechnology and Biomaterials IIB e.V.,Rostock, GermanyUniversity Medicine Rostock, Institute for Biomedical Engineering,Rostock, GermanyUniversity Medicine Rostock, Institute for Biomedical Engineering,Rostock, GermanyIn 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.https://doi.org/10.1515/cdbme-2020-3085vascular stentsartificial heart valvesin-vitro testingstandardizationmedical device regulation |
| spellingShingle | 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 Current Directions in Biomedical Engineering vascular stents artificial heart valves in-vitro testing standardization medical device regulation |
| title | 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_short | 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 |
| topic | vascular stents artificial heart valves in-vitro testing standardization medical device regulation |
| url | https://doi.org/10.1515/cdbme-2020-3085 |
| work_keys_str_mv | AT schmidtwolfram standardizationofinvitrotestingforcardiovascularimplantsintheeraofeuropeanmedicaldeviceregulation AT brandtwunderlichchristoph standardizationofinvitrotestingforcardiovascularimplantsintheeraofeuropeanmedicaldeviceregulation AT stiehmmichael standardizationofinvitrotestingforcardiovascularimplantsintheeraofeuropeanmedicaldeviceregulation AT kaulesebastian standardizationofinvitrotestingforcardiovascularimplantsintheeraofeuropeanmedicaldeviceregulation AT siewertstefan standardizationofinvitrotestingforcardiovascularimplantsintheeraofeuropeanmedicaldeviceregulation AT bockandrea standardizationofinvitrotestingforcardiovascularimplantsintheeraofeuropeanmedicaldeviceregulation AT schmitzklauspeter standardizationofinvitrotestingforcardiovascularimplantsintheeraofeuropeanmedicaldeviceregulation AT kurzhalsanja standardizationofinvitrotestingforcardiovascularimplantsintheeraofeuropeanmedicaldeviceregulation AT grabowniels standardizationofinvitrotestingforcardiovascularimplantsintheeraofeuropeanmedicaldeviceregulation |