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Development of standardized test methods for cytocompatibility considering special demands on implants and medical products for the medical device industry

Cel



The aim is to combine various methods and criteria for cytocompatibility according to the International Standard EN 30993 part 1 and 5 to one test programme which can be applied in industry for routine quality assurance purposes and the CE-certification. This includes the usage of practical invitro tests for cell adhesion, cell spreading and cell migration. The programme will be tested according to the practical application. The refinement of test methodology for the direct contact of cells and material is one essential objective. The seeding of cells on the fixed biomaterial avoid mechanical stress of the cells, undefined contact between cells and material and lead to further information like cell spreading. The developed standard test method concentrates on the following criteria for practical application: membrane integrity, cell morphology, DNA-synthesis of single cells and cell spreading. The partners test in-vitro tests for the development of medical devices. These tests will give further informations about the specific suitability of the materials, here for catheters and intraocular lens material. The results will be compared with in-vivo experiments. The industrial partners test the method for example in product and process design as well as in batch tests to gain optimal results.
Experiences in industry are combined with the founded knowledge of the partners at universities. The result is summarized in a manual and is passed on in workshops, seminars and so on. A further objective is to enable the application of a broad ISO or European standard for the specialist in industry. Looked at from the point of view of a high life-span, increasing expenses for the health system, law restricting animal testing and considering the economic factors, the in-vitro testing of implant materials becomes more and more significant. Therefore it is essential to transfer the extensive ISO and European standards for cytocompatibility tests to the practical applications that can be easily realized in industry.
Furthermore, the ongoing scientific results which will come up during the duration of this project and the specific knowledge of the partners of this project can have a significant impact on the project 'RTD in Support of Community Policy', section 2.3 especially in relation to Methods Development(Category III within 'SMT Dedicated Call for Proposals in Support of Community Policy'), item 17 ('The development of a standardized test method for the cytocompatibility of silicone polymers used in mammary implant') and item 18 ('The development of a standardized test method for the cytocompatibility of dental materials'). The standardized methods and procedures for testing the cytocompatibility of medical devices, which is the declared aim of this project, can easily be transferred to the above mentioned items within the project 'Support of Community Policy'.

Dziedzina nauki

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System finansowania

CSC - Cost-sharing contracts

Koordynator

Rheinisch-Westfälische Technische Hochschule Aachen
Wkład UE
Brak danych
Adres
30,Pauwelsstrasse 30
52057 Aachen
Niemcy

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Brak danych

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Ostatnia aktualizacja: 27 Maja 1998

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Permalink: https://cordis.europa.eu/project/id/SMT4952040/pl

European Union, 2024