HIGHPOWER’s test methodology is based on methods outlined in the United States Pharmacopeia/National Formulary, ANSI/AAMI/ISO TIR15499 – Biological Evaluation of Medical Devices – Guidance on the Conduct of Biological Evaluation within a Risk Management Process and various parts of the ANSI/AAMI/ISO 10993 standard.

Biocompatibility can only be demonstrated for a particular material in relation to a defined set of circumstances, which include the purpose for which it is used and the tissues with which it comes into contact. Therefore, the consideration of toxicology should be undertaken in context of the routes and duration of exposure and implications for actual availability of potential toxicants.

ISO 10993-1:2009, B.2.2.2 describes a continuous process by which a manufacturer can identify the biological hazards associated with medical devices, estimate and evaluate the risks, control these risks, and monitor the effectiveness of the control. Appropriate protection of the patient by weighing risks and benefits of medical devices is an essential element of any biological evaluation plan. Consideration of biological (toxicological) risk is only one aspect of the risk assessment of a medical device, which should consider all aspects of risk.

Tests:

  • Cytotoxicity Testing
  • Sensitization Testing
  • Irritation Testing
  • Blood Hemolysis Testing

We’re constantly adding new test to meet our customer’s expectations. If you don’t see your required biocompatibility test listed, please contact us at info@highpowervtls.com with your inquiry.