The products offered by the medical device sector are subject to various biocompatibility regulations, depending on the intended application and complexity of the device.

We carry out a wide range of laboratory tests to ensure the quality and safety of medical devices in compliance with applicable harmonized standards. Our team of experts can also develop and validate methods for all requirements related to medical devices.

  • Cytotoxicity  (EN ISO 10993-5)
  • Acute systemic toxicity (EN ISO 10993-11)
  • Skin sensitization (GPMT) (EN ISO 10993-10)
  • Intracutaneous reactivity (EN ISO 10993-10)
  • Acute ocular irritation (EN ISO 10993-10)
  • Skin irritation (EN ISO 10993-10)
  • Nasal mucosal irritation (EN ISO 10993-10)
  • Oral mucosal irritation (EN ISO 10993-10)
  • Penile irritation (EN ISO 10993-10)
  • Rectal irritation (EN ISO 10993-10)
  • Vaginal irritation (EN ISO 10993-10)
  • Hemocompatibility (EN ISO 10993) (partnership)
  • Sub-chronic toxicity and implantation test (EN ISO 10993) (partnership)
  • Mutagenicity studies
    • Bacterial reverse mutation test (Ames test) (OECD 471)
    • In vitro mammalian cell micronucleus test (OECD 487)
    • In vitro Mammalian Chromosome Aberration Test (OECD 473)
    • In vitro mammalian cell gene mutation test - Mouse lymphoma assay (MLA) (OECD 490)

Our most common tests and services

May 29th, 2020
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