Our Certificates
Accredited testing
PCA accreditation number AB 1659
Biological and biochemical testing of medical devices
In vitro cytotoxicity - MTT test
Compliance criteria:
PN EN ISO 10993-5:2009
In vitro cytotoxicity - XTT test
Compliance criteria:
PN EN ISO 10993-5:2009
In vitro cytotoxicity - NRU test
Compliance criteria:
PN EN ISO 10993-5:2009
In vitro cytotoxicity - CF test
Compliance criteria:
PN EN ISO 10993-5:2009
In vitro cytotoxicity - agar diffusion test
Compliance criteria:
PN EN ISO 10993-5:2009
Irritation using the reconstructed human epidermis
Compliance criteria:
ISO 10993-23:2021
In vivo skin sensitization - Buehler test
Compliance criteria:
ISO 10993-10:2021
Sensitization using Guinea Pig Maximisation Test
Compliance criteria:
ISO 10993-10:2021
Irritation using rabbit skin irritation test
Compliance criteria:
ISO 10993-23:2021
Irritation using rabbit intradermal reactivity test
Compliance criteria:
ISO 10993-23:2021
Local effects after implantation - subcutaneous implantation
Compliance criteria:
PN-EN ISO 10993-6:2017-04;
ISO 10993-6:2016
Local effects after implantation - intramuscular implantation
Compliance criteria:
PN-EN ISO 10993-6:2017-04;
ISO 10993-6:2016
In vivo systemic toxicity test
Compliance criteria:
PN-EN ISO 10993-11:2018-08
In vivo pyrogenicity test
Compliance criteria:
PN-EN ISO 10993-11:2018-08
In vitro tests in accordance with GLP
certification number of Bureau for Chemical Substances 21/2024/DPL
In vitro studies for basic cytotoxicity
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When applying for appointment as a Local Ethics Committee, please consider the following factors:
