Biocompatibility Testing

Biocompatibility of a device is based on device component materials, part of body exposed to device and the duration of exposure.

Device classification based on contact:
* Surface Devices - Devices in contact with skin (electrodes, external prosthesis, fixation tapes), mucous membrane (contact lens, colonoscopes) and breached or compromised surfaces (dressings, occlusive patches).
* External Communicating Devices - Devices in contact with blood path indirectly (blood administration sets, transfer sets), tissue/bone/dentin communicating (laparoscopes, dental fillings, skin staples) or circulating blood (intravascular catheters, immunoadsorbents).
* Implant Devices - Devices principally in contact with tissue (pacemakers, drug supply devices) or bone (orthopedic pins, plates) or blood (heart valves, stents).

Device Classification based on exposure:
* Limited Exposure: < 24 hours * Prolonged Exposure: > 24 hours but < 30 days (single, multiple or long-term use) * Permanent: > 30 days (single, multiple or long-term use)

The biocompatibility tests required for a device is decided based on the biocompatibility matrix.