Medical Device Biocompatibility Testing

We offer tests which evaluate cytotoxicity and biological risks within the chemical make-up of a medical device.

Medical Device Biocompatibility Testing

Our biocompatibility testing allows the accurate characterisation of a medical device’s patient contact time and level of invasiveness. This is a fundamental step in allowing a medical device to be recognised as safe for use, and subsequently being introduced into the market. Additionally, these tests can be further utilised as an evaluating tool when comparing replacement materials during changes in manufacturing processes. All medical devices which encounter human tissue should be subject to biocompatibility testing, critically cytotoxicity evaluation.

Test labs offer tests which aid in addressing the biocompatibility of medical device materials. These tests are performed to ISO 109993-5 to determine cytotoxic potential.

ISO 10993 Biocompatibility 

Biocompatibility testing is a critical part of the regulatory approval process for medical devices. Our Cytotoxicity testing (ISO 10993-5) is a crucial test for determining the effects of any medical device that encounters human tissue. This in-vitro test involves the extraction of potential toxins from the medical device through cell culturing techniques, which is validated by the ISO 10993-12 standard. The device extracts are then exposed to mammalian cells of mice origin (L929 or BALB/3T3 cells), under a range of concentrations. Cytotoxic effects are then observed through a variety of qualitative (Colony formation) and quantitative (NRU, MTT and XTT) tests. Our service is available to all medical devices which are prepared in accordance with ISO 10993-12.

Explore our medical device testing services

Disinfection products for medical devices

We test the efficacy of a wide range of disinfectants for medical devices, including disinfection technologies and robots.

Clinical Evaluation

We develop and implement procedures to collect, appraise, and analyse clinical data pertaining to your medical device.

Material compatibility assessment

We analyse test item materials at both sample and product level to assess process compatibility

See our research & testing facilities

Microbiology Laboratory

We are fully equipped to perform a wide variety of microbiology tests using bacteria, yeast, fungi, and bacterial spores.

Test chambers

We have built state of the art Test Chambers – all with a stainless steel interior and equipped with a wide range of sensors.

Chemistry Laboratory

Our chemistry lab is fully equipped to perform a wide variety of tests, that supports formulation and materials

Strong foundations are built with robust Quality Management Systems
Insight December 11th 2022

Medical Device Safety Testing – MDR focus on material compatibility

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