BIOCOMPATIBILITY STUDIES

     

    In vivo and in vitro studies conducted to evaluate the biocompatibility of medical devices or other materials, or to examine the potential toxicity of an extremely heterogeneous category of products in contact with the living organism, simulating the interactions between the material used and the patient's tissues.

    • Cytotoxicity test

    In vitro tests conducted in order to acquire preliminary information on the general toxicity of the device and determine any biological damage caused by the substances it releases by observing the effects they produce on mammalian cells.

    UNI EN ISO Standard 10993-5: In vitro cytotoxicity tests

    EU Regulation 745/2017 relating to medical devices, amending Directive 2001/83 / EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 and repealing Council Directives 90/385 / EEC and 93/42 / EEC

    • Genotoxicity test

    (Mouse Lymphoma Assay)

    In vitro mammalian cell gene mutation test, widely used to determine the genotoxic potential of a substance, useful in screening for new molecules, especially new drug candidates and medical devices.

    UNI EN ISO Standard 10993-3: Genotoxicity, carcinogenicity and reproductive toxicity tests

    • Tests of irritability and sensitization

    In vitro and in vivo tests to determine the irritant activity of a chemical substance by evaluating the local inflammatory response to single or repeated applications of the substance studied at the skin or eye level. Intracutaneous reactivity test.

    LLNA (Local Limph Node Assay)

    For the in vivo determination of the irritant activity of a chemical substance by evaluating the local inflammatory response to single, repeated and continuous applications of the substance studied

    UNI EN ISO 10993-10 standard: Skin irritation and sensitization tests.

    OECD Guideline 404: Acute Dermal Irritation/Corrosion

    OECD Guideline 405: Acute Eye Irritation/Corrosion

    OECD Guideline 406: Skin Sensitisation

    OECD Guideline 439: In Vitro Skin Irritation

    OECD Guideline 442B: Local Lymph Node Assay: BRDU-ELISA or –FCM

    OECD Guideline 492: Reconstructed Human Cornea-Like Epithelium (Rhce) Test Method For Identifying Chemicals Not Requiring Classification And Labelling For Eye Irritation Or Serious Eye Damage

    OECD Guideline 496: In vitro Macromolecular Test Method for Identifying Chemicals Inducing Serious Eye Damage and Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage

    • Skin corrosion test

    OECD Guideline 431: In Vitro Skin Corrosion: Human Skin Model Test

    OECD Guideline 435: In vitro Membrane Barrier Test Method for Skin Corrosion

    • In vivo implantation test:

    Implantation under aseptic conditions and evaluation of the macroscopic and microscopic effects on the surrounding tissues.

    ISO Standard 10993-6: Tests relating to local effects after implantation

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