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Update on current revisions of ISO 10993 medical device standards and their implication for testing

A large number of experts met in June 2015 in Lund, Sweden, to discuss new scientific developments and challenges to be included in the revision of the ISO 10993 standards, used in the biological evaluation of medical devices.

Three major standards, ISO 10993-1, -17 and -18 are to be revised. For ISO 10993-1 "Evaluation and testing within a risk management process" it was discussed to change the flow-chart describing the systematic approach to the biological evaluation of medical devices, with a strong focus on the chemical characterisation of the medical devices. By including additional requirements, chemical characterisation and cytotoxicity testing will be mandatory while all other toxicological endpoints will be evaluated within a toxicological risk assessment.

A major revision of ISO 10993-17 on allowable limits for leachable substances is in the works. Risk assessment approaches to use the concept of Threshold of Toxicological Concern (TTC), already established and accepted for genotoxic pharmaceutic impurities, are in discussion. If it can be shown that an impurity is below the TTC, then it is assumed that the chemical substance is of no significant risk.

A major revision will be made to ISO 10993-18 to incorporate the technical and scientific experience developed during the last 10 years since its publication, including a more detailed description of experimental requirements for the investigation of extractables and leachables and a revision of the stepwise chemical characterisation process, including the setting of the analytical evaluation thresholds (AETs) in alignment with the TTC-concept.

Based on the proposed revisions, it can be foreseen that in the future chemical characterisation will be a key parameter in the risk management process of medical devices. Our laboratories are already aligned to the new requirements and biological evaluations, including biocompatibility studies, chemical characterisations, and toxicological assessment performed on a regular basis by our experts.