TentaMedix provides a highly sophisticated in-vitro platform for testing of medical devices, pharmaceuticals and biological active substances using cellular test systems.
The evaluation of biocompatibility of medical devices is specified in the standard series DIN EN ISO 10993 and represents an absolute prerequisite prior to the performance of animal studies.
Determination of cytotoxicity in-vitro
- According to DIN ISO 10993-5 / USP <87>
- Annex A: Neutral red uptake (NRU) cytotoxicity test
- Annex D: XTT cytotoxicity test
- Determination of photoxicity (OECD TG 432)
Occular corrosion and irritation
- Human corneal epithelium test: OECD TG 492
- Fluorescein Leakage test: OECD TG 460
Skin irritation and sensitization
- In vitro skin irritation on reconstructed human epidermis: ISO 10993-10 / 23 (OECD TG 439)
- ARE-Nrf2 Luciferase Test Method (Kerationsens assay): OECD TG 442d
- Human Cell Line Activation test (h-CLAT): OECD TG 442e
- Skin corrosion in vitro (OECD TG 431)
- Bacterial reverse mutation test (AMES-test): DIN ISO 10993-3 / OECD TG 471
- In-vitro mammalian micronucleus test (MNT): DIN ISO 10993-3 / OECD TG 487
- Bacterial Endotoxin Testing (BET) LAL test Ph. Eur. 2.6.14
- Non endotoxin pyrogens (NEPs) monocyte activation test: Ph. Eur. 2.6.30
Bioburden and Sterility
- Determination of Bioburden as well as the product specific recovery (ISO 11737-1, Ph. Eur 2.6.12)
- Examination of the sterilization process (ISO 11737-2)
- Determination of residual and Host Cell DNA/RNA/Protein
- Determination of DNase/RNase contaminants
- Determination of Protease contaminants
TentaMedix’s platform of biological /medical device risk assessment according to ISO 10993 is supplemented by the chemical characterization of test items (ISO 10993-18) as well as with the determination of leachabels / extractables (ISO 10993-17) and the proper generation of extracts from medical devices (ISO 10993-12). The chemical characterization and the leachables / extractables testing is performed by our accredited partner labs within the Tentamus network.
In addition to our in-vitro testing platform – in cases where in-vitro testing is limited – the determination biological reactivity of test items in defined by in-vivo test systems, in detail
- ISO 10993-2 – Animal welfare regulations
- ISO 10993-6 – Determination of local effects upon implantation
- ISO 10993-11 – Determination of systemic toxicity
- ISO 10993-20 – Principles and methods of immune toxicology
The in-vivo tests are performed by qualified partner laboratories.
TentaMedix is GMP certified and accredited according to the ISO 17025 by DAkkS and ZLG. We offer a professional service for testing of medical devices according to Medical Device Directive 93/42 / EEC (MDD). In addition we offer GMP compliant method development, validation and routine testing of your finished products, API, in-process controls of pharmaceuticals and biologics.