Medical Device Biocompatibility Testing

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

Our Accreditations

Our biocompatibility testing is a fundamental step in allowing a medical device to be recognised as safe for use. 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 10993-5 to determine cytotoxic potential.

To determine which test are relevant to your device, Test labs offer a biological evaluation plan (BEP) which will identify the tests needed for your medical device, as well as sourcing available information on your product. After constructing the BEP and performing the required tests and sourcing the biocompatibility information, Test labs offer a biological evaluation Report (BER) with the complete set of justifications and results on your product.

ISO 10993-5 Test for cytotoxicity – in vitro methods

‘in vitro’ tests are free from animal cruelty, hence a more rapid and sensitive procedure. Qualitative cytotoxicity tests outcomes in an assigned cytotoxic score (0-4) which is dependent on the percentage of cell death (lysis), and overall cell structure (morphology). Whereas quantitative tests measure the metabolic activity of the cells, consequently allowing the measurement of living (viable) cells. Devices are considered cytotoxic if less than 70% cell viability occurs post-treatment with medical device extracts.

ISO 10993-23 Tests for irritation – in vitro methods

The irritation testing in accordance with ISO 10993-23 allows for detection of irritants in medical devices. With the introduction of the In Vitro Recombinant human Epidermis (RhE) model for skin irritation, manufacturers can now look to determine irritation potential of their devices without the need for animal testing. The testing allows for detection of irritants from polar and non-polar extracts of devices as well as through direct contact with compatible creams, liquids and gels. The test method determines the viability of the RhE cells, with <50% viability as an indication of irritant potential.

Biological Evaluation Plan

This plan acts as a risk assessment which evaluates the potential risks of the product, and whether they can be justified with existing data, or requires further biocompatibility testing. The BEP is an essential step in all classes of medical devices, as it is crucial for manufacturers to have complete technical files in order to ensure the safety, efficacy and performance of a product. This is re-instated is the ISO 10993 standard which states 'the biological evaluation of any material or medical device intended for use in humans shall for part of a structured biological evaluation plan within a risk management process in accordance with ISO 14971'.

Biological Evaluation Report

Upon the knowledge compiled in the BEP, a biological evaluation report (BER) can be issued. Within this report, all the justifications and testing performed will be stated. If the BEP indicates that all the materials have good evidence of safety, the processing of the material has no possibility of changing the safety, and there is overall no risk of contamination and the combination of the new material to the product is not toxic, then the BER will finally conclude that there is no further testing that is required.

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Explore our medical device testing services

Clinical Evaluation

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

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Medical devices bioburden testing

Our team will determine the presence or absence of bioburden on your sterile or non- sterile medical devices.

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Disinfection products for medical devices

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

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Explore our laboratory areas

Microbiology Laboratory

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

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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.

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Chemistry Laboratory

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

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Strong foundations are built with robust Quality Management Systems

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