B Biological Evaluation is estimation of biological responses of the product to ensure safety and efficacy with patient and user. Biological Evaluation of Medical Devices is a series of tests performed with the help of international standards pre-clinically either through In-vitro or In-vivo techniques and may upon animal models to assess the biological safety and efficacy of the medical device within the risk management process. It plays a key role in determining potential toxicity resulting from contact with a material or medical device and protects the patient from potential biological risks.
Biological Evaluation Report and Biocompatibility testing – Manufactures, please contact us.
A Biological Evaluation Plan is used to prove the safety of the device by demonstrating compliance to corresponding standards and avoiding unnecessary testing of the device. It is the primary step in the biocompatibility evaluation of medical devices. It aids in assessment of risks involved and develop a prior strategy to mitigate them. Biological Evaluation is an essential element demonstrated by the manufacture to display the safety of the medical device. In contempt of numerous benefits of medical devices still have some degree of risk even when used appropriately. On this basis, biological evaluation is a fundamental frame of risk management process where risk assessment must include biological evaluation plan. Such kind of evaluation plan is described in the ISO 10993 series for both Europe and the United states. As per ISO 10993 -1 standard, a biological evaluation plan for safety should start with the material, physical and chemical characterizations, which includes categorization of materials, forces surrounding tissues, leachable, extractable, residues, chemical composition etc., factors. After collection of all the supporting data, further investigations like risk identification, selection of appropriate test, test procedure, sampling conditions can be planned accordingly.
The Biological Evaluation Report is a consolidated summary of all biological tests performed and explanations/reasons for tests not performed.
Need ready to edit and use templates? Click Here>>