ISO 10993-6:2026 was published in April 2026, replacing the third edition from 2016. If you're running implantation studies or reviewing biocompatibility data packages right now, this is the version that applies. The changes aren't cosmetic. Several of them close gaps that have caused inconsistent study design and confusing regulatory submissions for years. This article covers what changed and what it means practically for manufacturers, CROs, and regulatory affairs teams. Wh

Every implantation study under ISO 10993-6:2026 is built on a comparison. Your test sample goes in alongside a control, and the tissue responses to both are evaluated side by side. The conclusion — whether your device produces an acceptable local tissue response — depends entirely on what that comparison shows. That makes control selection one of the most consequential decisions in implant study design. Get it wrong and borderline histopathology results become very difficult