IN VIVO STUDIES
ISO-compliant IN VIVO studies
Biological and biochemical tests for medical devices
In vivo skin sensitization using the Buehler test
Compliance criteria:
ISO 10993-10:2021
Guinea Pig Maximisation Test
Compliance criteria:
ISO 10993-10:2021
Irritation using the rabbit skin irritation test
Compliance criteria:
ISO 10993-23:2021
Irritation using the rabbit intradermal reactivity test
Compliance criteria:
ISO 10993-23:2021
Local reaction after in vivo implantation - subcutaneous implantation
Compliance criteria:
PN-EN ISO 10993-6:2017-04; ISO 10993-6:2016
Local reaction after in vivo 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
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When applying for appointment as a Local Ethics Committee, please consider the following factors:
