Medical Device Biological Evaluation

Biological Evaluation

QualiMetrix performs a biological evaluation of any medical device as a part of the risk management process of the product.

A series of well justified and documented steps are performed in order to evaluate the data that could be generated from any available source such as previous studies, equivalent products, literature review and in-silico data.

At the end of the biological risk assessment, as required by ISO 10993-1: 2018, the appropriate biocompatibility tests are selected and performed.

QualiMetrix performs testing to evaluate biocompatibility appropriate to the intended use of the component material or finished product of medical devices. The company offers in vitro and in vivo studies, where appropriate and alternative non-animal validated in-vitro studies.

Cytotoxicity

The in-vitro cytotoxicity test is one of the most important indicators of the biological evaluation system.

In-vitro assays are used to assess the possibility of a test article to cause the death of cells in culture or to prevent their multiplication. Cytotoxicity tests employing cell culture techniques shall be used to determine the lysis of cells (cell death), the inhibition of cell growth, colony formation and other effects on cells caused by medical devices, materials or their extracts.

Irritation

Irritation tests shall be used to estimate the irritation potential of medical devices using an appropriate site for application such as the skin, the eyes and mucous membranes in a suitable model.

The tests performed shall be appropriate for the route and duration of exposure or contact. The intracutaneous reactivity test shall be used to assess the localised reaction of tissue to the test extracts. This test is applicable where the determination of irritation by dermal or mucosal tests is inappropriate.

Sensitisation

Skin sensitisation is an immunological process that is described in two phases: the induction of sensitisation and the subsequent elicitation of the immune reaction.

Sensitisation testing evaluates the ability of leachables to cause Type IV hypersensitivity. The tests are designed to determine if a patient will develop a reaction with repeated exposure to a medical device. Appropriate pre-screening in-vitro tests are performed to avoid costly and time-consuming animal testing.

Genotoxicity

Genotoxicity tests use mammalian or non-mammalian cells, bacteria, yeasts, fungi or whole animals to determine whether gene mutations, changes in chromosome structure or other DNA or gene changes are caused by the test samples.

Haemocompatibility

Haemocompatibility tests are in-vitro assays used to assess the possibility of a test article to cause adverse effects on red blood cells (haemolysis, thrombosis and coagulation) platelets and complement system.

The purpose of the test is to determine the potential haemolytic effect (destruction of red blood cells with subsequent release of haemoglobin) of the test article extract on blood.

The in-vitro haemocompatibility tests available include:

  • Haemolysis
  • Coagulation
  • Platelets
  • Haematology
  • Complement system

Material – mediated pyrogenicity

Pyrogen is any substance that can induce fever. Testing for pyrogens is required for the release of many healthcare products.

Because pyrogen contaminations in pharmaceutical products, biotherapeutics, cosmetics and on medical devices can induce life-threatening fever, it is mandatory for manufacturers to ensure that the pyrogen concentrations do not exceed certain limits.

Carcinogenicity

The carcinogenicity test determines the carcinogenic potential of medical devices, materials and extracts using multiple exposures for a major portion of the life-span of the test animal.

Appropriate pre-screening in-vitro tests are performed to avoid costly and time-consuming animal testing.

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