ISO 10993 — Biological evaluation of medical devices
Also known as: ISO 10993-1, biocompatibility standard
The multi-part framework governing how a medical device is assessed for biological safety, including cytotoxicity, sensitisation, irritation and effects after implantation.
What it covers
What it means in practice
Compliance with ISO 10993 is expected of every legally marketed implant, which makes it a floor rather than a distinguishing feature. If a manufacturer presents biocompatibility testing as a selling point, it is describing something its competitors also had to do. Where it becomes genuinely interesting is with newer materials and surface treatments, because the biological evaluation has to be repeated when a material or its processing changes.
Sources
Numbers match the citations beside each claim above.
Primary sources
- [1]ISO — Online Browsing Platform and standards catalogue — International Organization for Standardization. Accessed 2026-07-22.