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Valid from 04.08.2026

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This ISO 10993-6 2026 vs 2016 comparison helps manufacturers and regulatory teams quickly identify what has changed in the biocompatibility testing requirements for local effects after implantation. Our gap analysis breaks down clause-by-clause revisions, so your team can update test protocols and technical documentation without re-reading the entire standard. This standard aims to measure tissue reaction, assess local biocompatibility risks, and confirm safe use for medical devices. It is used to describe in detail how tests should be performed for both subcutaneous (under the skin) and intramuscular applications. The standard is applicable to the below medical devices: Orthopedic implants (plates, screws, prostheses) Cardiovascular Devices (Stents, artificial heart valves) Dental implants Wound closure Materials (sutures, biomaterials) Medical Materials with Long-Term contact Whether you're updating a Design History File, preparing a 510(k) submission, or responding to a notified body query, this ISO 10993-6 2026 vs 2016 report gives you a clear, audit-ready summary of exactly what's new in the 2026 revision compared to 2016.