ISO 10993-1:2025 : ce qui a changé

What changed in ISO 10993-1? A sixth edition replaced the 2018 text in November 2025. And FDA now recognizes it, with exceptions and a long transition. Start with the title. The 2018 edition covered evaluation and testing within a risk management process. The 2025 edition covers evaluating biological safety within that process, reorganized around ISO 14971, with new guidance on exposure duration, materials characterization and identifying biological hazards. FDA's standards database added the new edition on May 25, 2026, with partial recognition: two parts are not recognized. Declarations to the 2018 edition are still accepted until July 1, 2029. After that, they are not. One more flag. For prolonged-contact devices, FDA says the new genotoxicity requirements may not match its 2023 guidance. Talk to the review office before you start your evaluation. Start with three things. One: list which edition each target market accepts. Two: note the two parts FDA does not recognize. Three: plan your biological evaluation around risk, not a list of tests. Risk first, then the tests. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.