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Risk assessment of medical devices for the oral cavity using a human oral mucosa epithelium model

The result's identifiers

  • Result code in IS VaVaI

    <a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F75010330%3A_____%2F22%3A00014038" target="_blank" >RIV/75010330:_____/22:00014038 - isvavai.cz</a>

  • Result on the web

    <a href="https://proceedings.altex.org/data/2022-02/Altex_2022_%20Linz.pdf" target="_blank" >https://proceedings.altex.org/data/2022-02/Altex_2022_%20Linz.pdf</a>

  • DOI - Digital Object Identifier

Alternative languages

  • Result language

    angličtina

  • Original language name

    Risk assessment of medical devices for the oral cavity using a human oral mucosa epithelium model

  • Original language description

    Medical devices (MDs) have invaluable roles in today’s healthcare. MDs used in oral cavity can be defined as a broad range of products, from creams and ointments for treating sores or aphthae, to dental adhesives and materials used in dental prosthetic devices. In the oral cavity, these MDs get into direct contact with oral mucosa and must be assessed for safety. Bio-compatibility assessment is usually still conducted in animals, however alternative in vitro methods are now available due to development of cell and tissue engineering, for example in vitro reconstructed epidermis test for intra-cutaneous testing (ISO 10993-23).

  • Czech name

  • Czech description

Classification

  • Type

    O - Miscellaneous

  • CEP classification

  • OECD FORD branch

    30304 - Public and environmental health

Result continuities

  • Project

    <a href="/en/project/8X20026" target="_blank" >8X20026: TraiN-SafeMDs:Training Network for improving knowledge on safety of medical devices - focus on oral cavity</a><br>

  • Continuities

    P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Others

  • Publication year

    2022

  • Confidentiality

    S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů