GLP Testing Unit – Certification

In August 2022, the area of the Multispecialty Laboratory and the animal Facility for Small and Large Animals of the Silesian Park of Medical Technology Kardio-Med Silesia obtained a certificate in the field of the Good Laboratory Practice (GLP) standard, which is an international quality system ensuring the highest reliability and correctness of the tests performed in the accreditation area. As part of the implemented standard, it will be possible to carry out biological evaluation of medical devices from the PN-EN ISO 10993 group of standards, as well as testing, based on OECD guidelines.

In the near future, the Research Unit plans to extend accreditation in Good Laboratory Practice to include studies in pharmacokinetics, histopathology and toxicological studies (within the scope of the PN-EN ISO 10993-11:2018-08 Biological evaluation of medical devices – Part 11: In vivo systemic toxicity testing (for acute, subacute, subchronic and chronic toxicity). It is also possible to perform the above tests without the GLP standard.

As a GLP Standard Testing Center, we have the ability to conduct tests in the scope of:

• PN-EN ISO 10993-5:2009: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity (including test on extracts, test by direct contact, agar diffusion, NRU, MTT, XTT),
• PN-EN ISO 10993-6:2009: Biological evaluation of medical devices – Part 6: Tests for local effects after implantation (including implantation in subcutaneous tissue, muscle, bone, brain tissue),
• PN-EN ISO 10993-10:2015-02: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization (including Guinea pig maximization test (GPMT), Closed-patch test (Buehler test)),
• PN-EN ISO 10993-23:2021-08: Biological evaluation of medical devices – Part 23: Tests for irritation (including in vitro reconstructed human epidermis model, in vivo irritation test).
• PN-EN ISO 10993-11:2018-08: Biological evaluation of medical devices – Part 11: Test for systemic toxicity; European Pharmacopoeia / ISO rabbit pyrogenic test – in vivo
• PN-EN ISO 10993-11:2018-08: Biological evaluation of medical devices – Part 11: Test for systemic toxicity