Objetivo 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'. Ámbito científico natural sciencesbiological sciencescell biologynatural scienceschemical sciencespolymer sciencesengineering and technologyindustrial biotechnologybiomaterialsmedical and health sciencesmedical biotechnologyimplantssocial scienceslaw Programa(s) FP4-SMT - Specific research and technological development programme in the field of standards, measurements and testing, 1994-1998 Tema(s) 0102 - Measurement and testing in the industrial development phase Convocatoria de propuestas Data not available Régimen de financiación CSC - Cost-sharing contracts Coordinador Rheinisch-Westfälische Technische Hochschule Aachen Aportación de la UE Sin datos Dirección 30,Pauwelsstrasse 30 52057 Aachen Alemania Ver en el mapa Coste total Sin datos Participantes (7) Ordenar alfabéticamente Ordenar por aportación de la UE Ampliar todo Contraer todo Biocom SA Francia Aportación de la UE Sin datos Dirección 24,Avenue de la Baltique 91942 Les Ulis Ver en el mapa Coste total Sin datos Kreco - Kreiner Consulting Gesellschaft für Wissenschaftlich- Technisches Projektmanagement mbH Alemania Aportación de la UE Sin datos Dirección 16,Möhlstrasse 81675 München Ver en el mapa Coste total Sin datos Labor Rolf Siegel M.D. Alemania Aportación de la UE Sin datos Dirección 180,Vorsbacher Strasse 97078 Würzburg Ver en el mapa Coste total Sin datos Tecnobiomateriali Srl Italia Aportación de la UE Sin datos Dirección Via XXIV Maggio 60 56100 Pisa Ver en el mapa Coste total Sin datos Università degli Studi di Pisa Italia Aportación de la UE Sin datos Dirección Via Diotisalvi 2 56126 Pisa Ver en el mapa Coste total Sin datos Université Pierre et Marie Curie - Paris VI Francia Aportación de la UE Sin datos Dirección 27,Rue Chaligny 75571 Paris Ver en el mapa Coste total Sin datos Vygon SA Francia Aportación de la UE Sin datos Dirección 5-11,Rue Adeline 95440 Ecouen Ver en el mapa Coste total Sin datos