Testing laboratory Biological safety
To eliminate unacceptable risks of your materials and devices
Biosafety means that a medical device or material is free from unacceptable risks in the context of its intended use.
Biological safety can be verified and ensured through biological testing, assessment of the effects of leachable substances, morphological characteristics and performance of the medical device or material.
The testing of biological safety is defined in a separate series of standards, the ISO 10993.
Our company offers comprehensive services for the assessment of biocompatibility (biological safety) of medical devices according to ISO 10993. Our range of services includes all relevant biological tests, either in-house or with qualified cooperation partners. We support our customers in the strategy development for the selection of biological tests and in the decision-making process.
On request, we prepare biological assessments and toxicological evaluations according to ISO 10993-1 for our customers' products on the basis of the test results.
We offer the following services for the verification of biological safety:
- preparation of the biological assessment according to 10993-1
- chemical characterisation according to ISO 10993-18
- cytotoxicity test according to ISO 10993-5 (in vitro) (more)
- sensitization, irritation or intracutaneous reactivity according to ISO 10993-10
- material-related pyrogenicity according to ISO 10993-11
- acute systemic, subacute, sub-chronic and chronic toxicity according to ISO 10993-11
- implantation effects as per ISO 10993-6
- haemo-compatibility according to ISO 10993-4
- genotoxicity, carcinogenicity and reproductive toxicity according to ISO 10993-3
- degradation according to ISO 10993-13 to ISO 10993-16
Our company is committed to reducing animal testing, so we are constantly developing new in-vitro testing methods to verify the biological safety of medical devices.
In-vitro cytotoxicity test according to 10993-5
The in-vitro test for cytotoxicity is the most common biosafety test according to ISO 10993.
Our laboratory has an ISO 17025 accreditation and GLP certification for this test and has many years of experience with this cell culture-based test system, which is often used not only for end product testing, but also for monitoring cleaning processes, for example, or for the selection and inspection of incoming materials and raw materials or intermediate products.
In this test, an extract of the product to be tested is created. For this purpose, we have developed suitable extraction options for a wide variety of medical products.
The extract is brought into contact with the test cells. The viability of the cells is then determined by visual detection of a vital dye. A reduction in viability of more than 30% indicates a cytotoxic reaction.
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Should you have any questions about our services, please do not hesitate to contact us.