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Biocompatibility Studies
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Biocompatibility Studies on Medical Devices as per
ISO 10993 Guidelines

Vanta Bioscience provides services to the medical device industry by providing services according to the ISO 10993 guidelines and the US FDA modified ISO study matrix. Vanta Bioscience has satisfied clientele who have evaluated products like catheters, films, latex gloves, condoms, cannulas, sutures and other devices. The following types of tests are offered.
Cytotoxicity
Intracutaneous / Mucous Membrane Irritation
Dermal Sensitization
Mutagenicity Assays
Acute Systemic Toxicity
Implantation Tests

Cytotoxicity Tests
These tests involve the exposure of substances extracted from test material to one of two cell culture lines. Cell cultures are extremely sensitive to minute quantities of leachable chemicals and readily display characteristic signs of toxicity in the presence of potentially harmful leachables.

Sensitization tests
These tests estimate the potential for contact sensitization of devices through the testing of appropriate materials or extracts.

Irritation (Reactivity) Tests
These tests assess the localized reaction of tissues to device materials or extracts. For ocular, dermal and mucosal tissue contact, the appropriate test is selected. For breached tissue and blood contact, the Intracutaneous test is usually selected and uses only extracts. The dermal irritation test usually involves direct contact with the test material. The mucosal irritation test can involve either direct contact or use of extracts. The ocular tests usually use extracts. Extracts are prepared using solvents that will extract either hydrophilic (polar) or lipophilic (non-polar) compounds which may be present in the device materials.

Acute Systemic Toxicity Tests
These tests estimate the potential harmful systemic effects from a single exposure to polar or nonpolar extracts of device materials.

Sub Acute Toxicity
These tests are performed after single or multiple exposures to extracts of device materials. The exposure period is longer than typical acute toxicity tests, but not exceeding 10% of animal lifespan. The length of time for the test and the parameters evaluated will depend on the end use of the device.

Genotoxicology (Mutagenicity) Tests

These tests evaluate the ability of a material to cause mutation or gross chromosomal damage.

Implantation Tests
These tests assess the local effects of material or finished product on contact with living tissue. Using a needle or surgical procedure, a sample is implanted into the tissue site appropriate for the intended use of the device. After the selected duration of contact, the tissue sites are evaluated for gross changes and, if requested, histopathology.

Hemocompatibility Tests
An important measure of hemocompatibility is the hemolysis test, which measures the ability of a material or material extract to cause red blood cells to rupture. Hemolysis testing should be performed on all materials directly contacting the bloodstream, or any materials used to form a fluid conduit to the bloodstream.

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