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Tentamus Pharma & Med Deutschland GmbHBiological Safety Testing of Medical Devices

Biological Evaluation of Medical Devices / Biocompatibility

TPMD provides a highly sophisticated and accredited in-vitro platform for testing of medical devices according to the DIN ISO 10993. We are skilled to test pharmaceuticals and biological active substances using cellular test systems according to international accepted guidelines.

Determination of cytotoxicity in-vitro: ISO 10993-5 / USP <87>

According to DIN ISO 10993-5 / USP <87>
Read out: XTT / MTT in combination with optical classification of material dependent cytopathic effects

Skin irritation and sensitization in vitro: ISO 10993-10 / ISO 10993-23

In vitro skin irritation on reconstructed human epidermis: ISO 10993-10 / ISO 10993-23 / OECD TG 439)
Direct Peptide Reactivity Assay (DPRA) OECD TG 442c
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)

Occular corrosion and irritation in vitro

Human Corneal Epithelium like Test: OECD TG 492
Fluorescein Leakage Test: OECD TG 460

Genotoxicity in vitro: ISO 10993-3

Bacterial Reverse Mutation Test (AMES-test): DIN ISO 10993-3 / OECD TG 471
In-vitro mammalian Micronucleus Test: DIN ISO 10993-3 / OECD TG 487

Hemocompatibilty ex vivo: ISO 10993-4

Dynamic process using human whole blood in a closed loop system
Integrity of red blood cells: haemolysis / determination of total and plasma haemoglobin (HB)
Determination of complete blood composition (CBC)
Effects on coagulation: changes in total thrombocyte count, human platelet factor 4 (hPF-4), Prothrombin (PT), Fibrinogen (Fib), Thrombin time (TT), Thrombin / anti-Thrombin complex (TAT)
Activation of the immune system: determination of complement factors C3a, C5a, Sc5b-9

Endotoxin and Pyrogens

Bacterial Endotoxin Testing (BET): Limulus Amoebocyte (LAL) Test Ph. Eur. 2.6.14
Non Endotoxin Pyrogens (NEPs) Monocyte Activation Test (MAT): Ph. Eur. 2.6.30

Microbiology: Bioburden and Sterility

Determination of Bioburden as well as the product specific recovery (ISO 11737-1, Ph. Eur 2.6.12), validation and product testing
Test of sterility performed within a sterilization process (ISO 11737-2, Ph. Eur. 2.6.12), validation and product testing
Direct inoculation or rinsing of test item

Chemical characterization

Chemical characterization of test items and the determination of Leachbales & Extractables by sophisticated Chromatography / Mass Spectroscopy (LC-MS, GC-MS, HS-GC-HS. ICP-MS) according to the DIN ISO 10993-13/14/15/17/18 is performed by accredited partner labs.

Biocompatibility in-vivo

In addition to our in-vitro testing platform we offer – when claimed – the determination of biological reactivity in-vivo, 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. We offer a professional service for testing of medical devices according to Medical Device Directive 93/42 / EEC (MDD).

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Biological Safety Testing of Medical Devices

Biological Evaluation of Medical Devices / Biocompatibility TPMD provides a highly sophisticated and accredited in-vitro platform for testing of medical devices according to the DIN ISO...

Medical devices: Determination of skin irritation and sensitisation

Tentamus Pharma & Med Deustchalnd GmbH offers a comprehensive and accredited test platform for the testing of medical devices according to the requirements of the EU MDR and DIN ISO 10993. We are...

Bacterial Endotoxin & Pyrogens: Monocyte Activation Test

TPMD is accredited and GMP certified for the determination of bacterial endotoxin (BET) and non endotoxin pyrogens (NEPs). In addition to the classical Limulus Amoebocyte Test (LAL), we offer an in-ho...

Medical Devices: Cytotoxicity & Genotoxicity

Tentamus Pharma & Med Deustchalnd GmbH offers a comprehensive and accredited test platform for the testing of medical devices according to the requirements of the EU MDR and DIN ISO 10993. We are...