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Biocompatibility: ISO 10993

Within the general safety-testing framework, the device manufacturer is responsible for selecting and justifying the specific tests most appropriate for product safety and compliance with regulatory requirements.

We recommended that testing be performed to comply with GLP regulations. With years of experience in biocompatibility testing, the Medical Device Testing division provides exceptional expertise to assist medical device manufacturers in designing thorough, well-constructed testing programs that meet global compliance standards.

• Cytotoxicity Testing

  Cytotoxicity tests involve exposing cultured cells to substances extracted from your test material. Cell cultures are extremely sensitive to minute quantities of leachable chemicals and readily display characteristic signs of toxicity in the presence of potentially harmful leachables. In vitro cytotoxicity testing is also required to test the biocompatibility of medical devices. Typical testing programs will adhere the ISO test method to meet international regulatory requirements.

  • ISO Guinea Pig Maximization Sensitization Test

    Extracts of the device are prepared, and the skin surface of animals is exposed to the extract in the presence of an adjuvant. After a short waiting period, the animals are challenged with a lower dose of the same extract to estimate the potential for contact erythema, swelling, or delayed allergic response, or other edema responses through the testing of appropriate materials or extracts. Methods for both polymeric devices and liquid test articles available.

  • Buehler Dermal Sensitization Test

    Extracts of the device are prepared, and the skin surface of animals is exposed to the extract in the absence of an adjuvant for at least 6 hours. After multiple such exposures, the animal is challenged with a sub-irritating dose of the extract, and contact erythema, swelling, or delayed allergic response, or other edema responses are measured.

  • Repeated Patch Derma Sensitization Test

    Here, animals are sensitized and challenged with the test article itself rather than with an extract from the test article.
    Irritation Testing
    Irritation tests assess the localized reaction of tissues to device materials or extracts. The selection of a test method is based on intended patient contact type.

• Sensitization Testing

  Sensitization tests estimate the potential for erythema, swelling, or delayed allergic response through the testing of appropriate materials or extracts.

  • MEM Elution

    ISO MEM Elution Using L-929 Mouse Fibroblast Cells
    Solid materials are extracted in cell culture medium, and the extracts are placed in triplicate containers of L-929 mouse fibroblast cells. Cells are examined up to 72 hours for signs of toxicity.

  • MEM Elution

    ISO MEM Elution Using L-929 Mouse Fibroblast Cells
    Solid materials are extracted in cell culture medium, and the extracts are placed in triplicate containers of L-929 mouse fibroblast cells. Cells are examined up to 72 hours for signs of toxicity.

  • MEM Elution

    ISO MEM Elution Using L-929 Mouse Fibroblast Cells
    Solid materials are extracted in cell culture medium, and the extracts are placed in triplicate containers of L-929 mouse fibroblast cells. Cells are examined up to 72 hours for signs of toxicity.

• Irritation Testing

  Irritation tests assess the localized reaction of tissues to device materials or extracts. The selection of a test method is based on intended patient contact type.

  • ISO Intracutaneous Irritation Test

    Test material solution or an extract of a device is injected under the top layer of skin to test the possible irritancy of the test article compounds.

  • ISO Mucosal Irritation Test

    Materials that comes in direct or indirect contact with mucosal tissue receive repeated administration of a dose to observe possible irritation.

  • ISO Primary Skin Irritation Test

    This test is performed to assess the potential topical irritation from acute exposure or device material.