ISO 10993-1:2025 — FDA recognizes the sixth edition
The core part of the ISO 10993 series: requirements and general principles for evaluating the biological safety of medical devices within an ISO 14971 risk management process.
What changed?
Status: Recognized. FDA's database lists the sixth edition (2025-11) with a new title — 'Requirements and general principles for the evaluation of biological safety within a risk management process' — replacing the fifth edition (2018), whose title referred to 'evaluation and testing'. The scope now explicitly frames evaluation around risks from device constituents and tissue-device interactions, including physical effects, across the device life cycle. For clause-level differences, obtain the standard from ISO and check the FDA recognition record for any transition period and the extent of recognition.
Source: FDA Recognized Consensus Standards — ISO 10993-1 (2-313)