The ISO 10993 standard series provides guidance for the biological evaluation of medical devices. The standards have increased the focus and understanding of chemical constituents in medical devices and their possible impact on patient safety. The upcoming revision of ISO 10993-17 marks a significant change from the 2002 version: Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances.
Difficult to establish relevant risk level
The latest revision of the ISO 10993-18 standard concerning Chemical characterization of medical device materials within a risk management process was published in 2020. It set the grounds for medical device manufacturers to investigate the chemical constituents of their devices more rigorously, for instance through extractables/leachables testing.
This resulted in a need for toxicological risk assessment of a considerably larger amount of data than in the past. Testing of extractables/leachables can often result in an overestimation of the exposure, and the difficulties to estimate the actual clinically relevant risk became more evident.
Part 17 facilitates realistic assessment of exposure to constituents
To support the biological safety, the overall weight of evidence must combine chemical constituent information, toxicological risk assessment and endpoint specific biocompatibility data to complete the biological evaluation.
The new ISO 10993-17 revision aims to facilitate guidance on conducting a toxicological risk assessment based on a toxicological screening limit to reduce the number of compounds to be evaluated. This offers a more realistic assessment of the patient risk of exposure to chemical constituents in medical devices.
Having this in mind, it is recommended that medical device manufacturers make an effort to stay ahead of these revised standards to ensure their chances of future regulatory success.
How we can help you
Our team of highly experienced toxicologists can assist you with your biological evaluation of medical devices including planning, test strategy, coordination with CROs, toxicological risk assessments and documentation of the outcome of these in a biological evaluation report in accordance with the ISO 10993-standard series. We can also assist you in communication with regulatory bodies, including notified bodies and FDA.
For more information, please contact:
Brian Svend Nielsen
bsn@dhigroup.com
Tel +45 4516 9140
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