Biological Evaluation ISO 10993

Do you have a medical device that will come into direct or indirect contact with the patient or user? It is essential that the biocompatibility of the medical device is assessed to ensure the medical device does not pose a biological risk to the patient or user.

The basis of a Biological Evaluation Report is to evaluate if there is sufficient evidence to demonstrate biological safety of a medical device through review of data available from the manufacturer and scientific literature.

The standard ISO 10993-1 – Biological Evaluation of Medical Devices – Evaluation and testing within a risk management process determines the required endpoints for assessment of a medical device based on the nature and duration of their contact with the body. The evaluation allows for the identification of gaps in the available data and additional data sets necessary to analyse biological safety.

Who can write Biological Evaluations?

According to ISO 10993-1, Biological Evaluation must be carried out by an expert assessor who has the necessary knowledge and experience. Where smaller or start-up companies do not have this expertise in-house, it is necessary that the evaluation is carried out by a suitable third party. At Patient Guard, our Regulatory Team have the necessary experience and qualifications to complete and review Biological Evaluations.

How is the service provided?

Patient Guard offers Biological Evaluation Plans and Biological Evaluation Reports to ISO 10993-1. For both services, the client will need to provide details of the material constituents of the device, manufacturing process and details of any post-production processing.

The Biological Evaluation Plan reviews the information provided and provides a gap analysis, detailing any endpoint testing required to prove biological safety of the device.

The Biological Evaluation Report includes a comprehensive review of available toxicological data relevant to the device and its materials, the results of any endpoint testing conducted and a final risk assessment of the biological safety of the device.

If you would like to discuss this service with us, then please contact us for more information.