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Biocompatibility
Part of the process of testing a medical device is a requirement to evaluate the biocompatibility of the device itself and/or the materials from which the device is constructed. This is a type of preclinical, in vivo safety testing (device safety testing) and is required for 510(k) clearance or PMA approval.
Absorption Systems performs biocompatibility testing of medical devices and component materials at our testing facility in San Diego, CA. Various biocompatibility tests are available, depending on the type of device, anatomical location, intended use and duration, etc. Test protocols comply with ISO 10993 standards and pertinent FDA guidelines.
The types of biocompatibility studies include:
- Implantation
- Hemocompatibility
- Sensitization
- Intracutaneous irritation
- Acute systemic toxicity
- Subchronic toxicity
- Chronic toxicity
Contact Absorption Systems for preclinical medical device biocompatibility and device safety testing.
Related Literature
This assay is used to determine the acute systemic toxicity of a device or device material in mice or rabbits and is required for most medical-grade materials and devices that are intended to make contact with the patient for more than 24 hours.
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These tests assess the local irritation potential of a test material, using sites such as skin or mucous membranes, in rabbits.
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Brochures
Preclinical medical device testing for efficacy and safety
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