ISO/TC 194 has published the long-awaited ISO 10993-1:2025. This standard is relevant for almost all medical devices that come into direct or indirect contact with the body, regardless of the type and duration of contact. The complete reorganization of the document is related to a change in its title to: “Requirements and general principles for the evaluation of biological safety within a risk management process.” The primary objective is to provide guidance for the preparation of a biological evaluation in alignment with a risk management process according to ISO 14971.
A major change compared to the fifth edition (ISO 10993-1:2018) is the adjustment of the calculation of contact duration. According to Clause 6.6.2, this calculation determines whether currently valid biological evaluations need to be updated in response to ISO 10993-1:2025. If the contact duration is extended due to the new calculation and additional biological effects (formerly referred to as endpoints) must be assessed, the biological evaluation should be updated accordingly. If this is not the case, ISO 10993-1:2025 can be applied during the next update as part of a change.
In addition to contact duration, certain contact types and biological effects have been revised, enabling a more realistic application to individual medical devices. Furthermore, the well-known Table A.1 from Annex A of ISO 10993-1:2018 has been split and linked to relevant clauses for better usability.
Contact us if you have questions regarding these regulatory changes or if you are unsure whether an update of your biological evaluation is necessary.
