Biocompatibility
Our methods for biocompatibility testing of medical devices are validated in accordance with DIN EN ISO 10993. We avoid animal experiments and have adopted the 3Rs principle (replacement, reduction, refinement). Our tests are conducted in vitro. We use cell cultures to examine factors such as cytotoxicity as well as skin irritation and sensitisation in accordance with the DIN EN ISO 10993.
In vitro biocompatibility testing
in accordance with
DIN EN ISO 10993
Our analytical procedures for testing biocompatibility:
In vitro determination of cytotoxicity
- DIN EN ISO 10993-5/USP <87>
- Read out: XTT/neutral red/MTT/MTS
- Toxicity of diffusing substances through agar diffusion (USP <87>)
- Determination of phototoxicity (OECD TG 432)
In vitro irritation and sensitisation
- Skin irritation on reconstructed human epidermis: DIN EN ISO 10993-10 / 23 (draft) / OECD TG 439
- ARE-Nrf2 Luciferase test method (KeratinoSens assay): OECD TG 442d
- Human cell line activation test (h-CLAT): OECD TG 442e
- In vitro skin corrosion: OECD TG 431
In vitro corrosion and irritation on ocular tissue
- Reconstructed human Cornea-like Epithelium Test (RhCe): OECD TG 492
- Ocular Corrosives and Severe Irritants: OECD TG 460
Genotoxicity
- Bacterial reverse mutation test (AMES test):DIN EN ISO 10993-3/OECD TG 471
- In vitro mammalian micronucleus test: DIN EN ISO 10993-3/OECD TG 487
Haemocompatibility
- DIN EN ISO 10993-4
- Static or dynamic process using human whole blood in a closed loop system
- Integrity of red blood cells: haemolysis and determination of total and plasma haemoglobin
- Cellular components of blood/blood count
- Effects on coagulation: 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: complement factors C3a, C5a, Sc5b-9
Determination of bacterial endotoxins and pyrogens
- Bacterial endotoxin testing (BET): limulus amoebocyte lysate (LAL) test: Ph. Eur. 2.6.14: verification and testing
- Determination of non-endotoxin pyrogens (NEPs): monocyte activation test (MAT): Ph. Eur. 2.6.30: verification and testing
Bioburden and sterility
- Determination of bioburden: DIN EN ISO 11737-1, Ph. Eur 2.6.12: verification and testing
- Sterility testing of medical devices as part of a sterilisation process: DIN EN ISO 11737-2: verification and testing
Generation of extracts from and chemical characterisation of medical devices
- Generation of extracts for biological and chemical characterisation (DIN EN ISO 10993-12)
- Chemical characterisation of test samples using LC-MS, GC-MS, HS-GC-MS and ICP-MS (DIN EN ISO 10993-13/-18)
- Detection of ethylene oxide residues (DIN EN ISO 10993-7)
In vivo testing
In addition to our in vitro testing platform, we offer in vivo testing by qualified partner laboratories:
- ISO 10993-2 – Animal welfare requirements
- ISO 10993-6 – Tests for local effects after implantation
- ISO 10993-10 – Tests for irritation and skin sensitisation
- ISO 10993-11 – Tests for systemic toxicity
- ISO 10993-20 – Principles and methods for immunotoxicology testing of medical devices