New scenarios for biological evaluation of medical devices with new ISO 10993-1 standard

by Paolo Pescio, Technical Referent, Eurofins Medical Device Testing

All medical devices, even when used appropriately, present a certain degree of risk to a patient. Manufacturers are required to weigh the risks and benefits of a device. An essential tool for the evaluation of the potential biological risks is the ISO 10993 series of standards.

The ISO Technical Committee 194 is in charge of this series and is currently revising the main standard: ISO 10993-1 “Biological evaluation of medical devices, Part 1: Evaluation and testing within a risk management process.” This part is an advanced stage as the draft (DIS) was approved for registration as final draft (FDIS) late last year. A lot of editorial and technical changes were made to the current document, and the most relevant are:

• A brand-new Annex A “Endpoints to be addressed in a biological risk assessment” (the annex containing the very famous table) was revised as normative, including new columns for specific endpoints in line with FDA requirements (physical and/or chemical information and material mediated pyrogenicity as well as columns for chronic toxicity, carcinogenicity, reproductive/developmental toxicity and degradation).
• Annex B was completely revised to include the provisions of ISO/TR 15499:2016 “Biological evaluation of medical devices-Guidance on the conduct of biological evaluation within a risk management process”.
• New approach for the evaluation of transitory contacting devices.
• Additional information on the evaluation of non-contact devices, nanomaterials, absorbable materials and breathing gas pathways in healthcare applications (referenced in ISO 18562 series) was provided.

The approach to biocompatibility is changing, moving towards an evaluation based upon review of relevant established scientific data, physico-chemical characterisation and in vitro testing, with in vivo testing only being carried out to fill gaps in our understanding. All device types (all device categories, with all types of contact, and all durations of contact) will require a chemical characterisation as a prerequisite for the risk assessment. The data coming from the chemical characterisation should be toxicologically assessed to elucidate the need for further tests to address the relevant biological endpoints for the device under evaluation.

Eurofins Medical Device Testing experts are happy to support manufacturers facing this change, providing testing and offering regulatory expertise during the entire medical device life cycle.