BIOCOMPATIBILITY TESTING

Submissions for approval of medical devices by regulatory agencies require that biocompatibility assessment be conducted to assure safety of the device or material. Safety data can be obtained by biocompatibility testing according to certain prescribed or recommended guidelines, including guidance documents developed by the International Organization for Standardization (ISO) and FDA. These guidelines include ISO 10993 -Biological Evaluation of Medical Devices and the guidance document released by FDA in 1995.

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The following are the important biocompatibility testing to be followed by medical device manufactures according to ISO 10993.

CYTOTOXICITY TESTS
The in vitro tests for cytotoxicity assess the response of cells in culture to direct contact with devices or to their extracts. ISO 10993-5 - Tests for In Vitro Cytotoxicity.

SENSITIZATION TESTS
Sensitization is the allergic response caused by the activation of complex cellular and humoral immunological mechanisms following exposure to an allergenic substance. ISO 10993-10 - Tests for Irritation and Sensitization recommends either of these tests.

INTRACUTANEOUS REACTIVITY TEST
The irritation potential of a test device or its leachates when administered to human patients can be extrapolated from the response obtained by injecting the extract of the test device intracutaneously to test animals.

SYSTEMIC TOXICITY AND PYROGENICITY TESTING
The release of the chemical constituents of a medical device, either by leaching or breakdown of the device, into the body has the potential for systemic toxicity. ISO 10993-11 - Tests for Systemic Toxicity.

Pyrogens are substances in devices that cause a febrile reaction. Bacterial endotoxin contamination is most commonly associated with such an adverse effect. ISO 10993-11 recommends testing the pyrogenicity potential of extractable substances derived from material leaching. ISO 10993 includes the Pyrogen test.

TESTS FOR GENOTOXICITY
ISO 10993-3-Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity, recommends that the potential for genetic toxicity be assessed using a series of at least three assays. Two of these assays should use mammalian cells as the test system, and the tests should cover the three levels of genotoxic effects: DNA effects, gene mutations, and chromosomal aberrations.

IMPLANTATION
The local effects of an implantable device or a material on tissue are assessed by implantation procedures that introduce the material or device, or a representative portion, into tissue. ISO 10993-6 - Tests for Local Effects after Transplantation, requires that the selected implant tissue region be appropriate for the evaluation of biocompatibility of the test material.

EYE IRRITATION TEST
Tests for assessing potential for eye irritation of test devices are required by ISO 10993-10, Tests for Irritation and Sensitization.

HEMOLYSIS
The interaction of devices or biomaterials with blood is an immediate and serious concern during safety assessment. The effects of the biomaterial may be broadly classified into cellular and humoral effects. ISO 10993-4, Selection of Tests for Interactions with Blood" (1992), suggests areas of hemocompatibility that should be tested, including thrombosis, coagulation, platelets and platelet function, haematology, and immunology.

REFERENCES

1. "Biological Evaluation of Medical Devices," ISO 10993, parts 1–12. (Geneva: International Organization for Standardization, various dates ).
2. "Use of International Standard ISO 10993, Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing" G95-1 (Rockville, MD: Department of Health and Human Services, FDA, 1995).
3. "Testing Methods to Evaluate Biological Safety of Medical Devices, Notice from the Office Medical Devices Evaluation Number 36" (Pharamaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, March 19, 2003).

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