
Medical devices
Tentamus Pharma & Med tests the safety of medical devices as part of development, registration and market surveillance.
We conduct chemical-analytical, microbiological and bioanalytical tests. Our comprehensive and accredited testing platform is geared to testing medical devices in accordance with the EU MDR and the DIN ISO 10993 series of standards.
Chemical characterisation
of medical devices
Tentamus Pharma & Med’s laboratories conduct chemical and instrumental tests in order to analyse raw materials, semi-finished goods and finished batches of medical devices. We perform qualitative and quantitative limit and content determination for a wide variety of substances such as residual solvents, heavy metals and endotoxins. We detect contamination with foreign matter and verify the sterility of medical devices.
Our instrumental analytics methods
- Atomic absorption spectrometry (AAS) using the following techniques: flame, nitrous oxide, graphite furnace, hydride and the corresponding digestion methods: acid digestion and microwave digestion to detect metals
- Inductively coupled plasma mass spectrometry (ICP-MS) for trace analysis of heavy metals such as mercury, lead or cadmium
- Gas chromatography (GC) with the following detectors: FID, NPD and MSD, e.g. determination of content and purity of pharmaceutical raw materials and finished products, residual solvents, fatty acid composition
In vitro analytics
for medical device certification
At Tentamus Pharma & Med, we use cell culture-based in vitro techniques when carrying out functional bioassays or effector cell assays in order to test and certify the biocompatibility of medical devices (DIN EN ISO 10993). This allows us to examine devices for factors such as cytotoxicity as well as skin irritation and sensitisation in various cell culture models.
Functional bioassays
- Tests for in vitro cytotoxicity (ISO 10993 – 5)
- Tests for skin irritation (ISO 10993 – 10/OECD 439)
- Tests for skin sensitisation (ISO 10993 – 10 / OECD 442 d/e
- Tests for ocular irritation/corrosion (OECD 460)
- Tests for ocular irritation (OECD 492)
- Tests for skin corrosion (OECD 431)
- Effector cell assays using various cell lines (cytotoxicity, apoptosis, ADCC, CDC)
- Proliferation/reporter gene assays
- In vitro potency assays

Microbiological testing
for medical devices
Our microbiological department specialises in detecting microorganisms such as aerobic and anaerobic bacteria, bacterial viruses (bacteriophages) as well as yeasts and moulds. We use classical microbiological methods of enrichment, isolation and identification of specific microorganisms to examine the sterility of raw materials, intermediate products and ready-to-use batches of medical devices.
We carry out clinical assays for the following purposes:
- Determination of bioburden (Ph. Eur. 2.6.12, ISO 11737 – 1)
- Detection of specific bacteria (Ph. Eur. 2.6.13)
- Pyrogen determination:
- bacterial endotoxin test (Ph. Eur. 2.6.14)
- Monocyte activation test (Ph. Eur. 2.6.30)
- Microbiological testing of cosmetics in accordance with CTFA or ISO standards
In vitro biocompatibility testing
in accordance with DIN EN ISO 10993
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 revised EU MDR and DIN ISO 10993.
Our analytical procedures for testing biocompatibility:
In vitro determination of cytotoxicity
- DIN 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: 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 ISO 10993 – 3/OECD TG 471
- In vitro mammalian micronucleus test: DIN ISO 10993 – 3/OECD TG 487
Haemocompatibility
- DIN 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: ISO 11737 – 1, Ph. Eur 2.6.12: verification and testing
- Sterility testing of medical devices as part of a sterilisation process: 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 ISO 10993 – 12)
- Chemical characterisation of test samples using LC-MS, GC-MS, HS-GC-MS and ICP-MS (DIN ISO 10993−13÷−18)
- Detection of ethylene oxide residues (DIN 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