A smart approach to chemical characterisation
by Daniele Lioi, Eurofins Medical Device Testing Italy
Medical devices must be safe and all risks associated with their use must be assessed. In fact, they can be made up of several constituents that could pose a biological risk to the patient during their clinical use. For this purpose, manufacturers often refer to the ISO 10993 series, the international standards to evaluate the biocompatibility of devices.
The approach to biological evaluation is changing: the new edition of ISO 10993-1 “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process” was recently approved as final draft. Several aspects have been revised and, as a result, more emphasis is given to chemical characterisation, which now is a clear prerequisite for risk assessment.
A proper chemical characterisation should identify any compounds that may leach into the patient’s body from the medical device. By identifying these potential leachable compounds and evaluating their toxicological risk, certain in vitro and in vivo tests may be eliminated. Instead of indiscriminately performing all in vitro and in vivo tests, it is only necessary to perform those that are relevant based on the types of chemicals identified during chemical characterisation. For example, if only compounds were identified during chemical characterisation for which it is known that these do not have genotoxic properties, additional biocompatibility testing for genotoxicity would likely be deemed unnecessary.
Moreover, chemical characterisation data are useful in risk assessment to establish equivalency, in toxicological terms, of a proposed material to an existing clinically established material and to manage a change in a medical device.
Eurofins experts offer medical device manufacturers a structured approach to perform thoughtful, tailored and well-designed chemical characterisation in the context of biological safety evaluation of a medical device, thus providing a strategic biological evaluation. This approach may even eliminate unnecessary biocompatibility assays, thereby reducing the amount of in vivo tests as well as related time and costs. The more you know, the more you save!
For more information, visit: www.eurofins.com/medical-device.