Cytotoxicity

Medical devices must be produced so that they do not have any adverse and undesired effects on the user. The EN ISO 10993 series of norms describes the biological assessment and testing as part of a risk management system. Testing for cytotoxicity is an important test point for all medical products having direct contact with the body.

In accordance with the standard, investigations are carried out in UFAG Laboratorien AG into whether extracts of medical products have a negative influence in-vitro in mammal cells. The vitality of cells in contact with the extract is measured and evaluated microscopically and by using photometric measurement of cellular metabolic processes.

The examination according to EN ISO 10993-5 provides important information for both product development and the selection of suitable materials, and also for batch release.

We are a GMP certified and ISO 17025 accredited contract laboratory in Switzerland with many years of experience in the testing of medical devices. We shall be pleased to provide support for any of your questions.

Read on to see which points you need to observe, or alternatively you can contact us.

How are extracts prepared?

The production of extracts is performed according to the intended use of the product at a defined temperature and using cell culture medium or ultrapure water as a solvent. When carrying out extractions at room or body temperature, it must be ensured that exclusively sterile products are investigated, in order to avoid disturbances from microbiological contaminations. If required, the test specimens are sterilised accordingly in the UFAG Laboratorien AG laboratory before extraction.

Selection of the extraction conditions is always performed in consultation with the client, in order to obtain meaningful results that are appropriate for the intended purpose of the medical product. Our specialists will be happy to advise you.

How will analysis be performed?

Active cultures of living mammal cells (for example fibroblasts from mice) have the extract added and are investigated microscopically for changes to the cell morphology after 24 and 72 hours. At the same time, changes to the cell viability are measured via the chemical reaction of a tetrazolium salt to a formazan dye.

Evaluation of the analysis

The influence of the extract is measured and assessed by comparing untreated cells with cells that have been treated with cytotoxic substances (positive control). If the cell viability falls to below 70% of the benchmark, it should be assumed that the test product possesses cytotoxic properties.

Our services in detail:

• Consultation on cytotoxicity testing
• Cytotoxicity testing
• Autres prestations selon cahier des charges ou sur demande.