Harmonised Standards — Biocompatibility
Official Source: EC Health — Harmonised Standards | Based on CID (EU) 2021/1182 (consolidated) and amendment CID (EU) 2026/193
Harmonised Standards List (9 standards)
| Standard | Title Summary | GSPR Reference | Status |
|---|---|---|---|
| EN ISO 10993-23:2021 | Part 23: Tests for irritation (ISO 10993-23:2021) | GSPR 10.4 (Biocompatibility) | Current |
| EN ISO 10993-9:2021 | Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019) | GSPR 10.4 (Biocompatibility) | Current |
| EN ISO 10993-12:2021 | Part 12: Sample preparation and reference materials (ISO 10993-12:2021) | GSPR 10.4 (Biocompatibility) | Current |
| EN ISO 10993-10:2023 | Part 10: Tests for skin sensitisation (ISO 10993-10:2021) | GSPR 10.4 (Biocompatibility) | Current |
| EN 455-3:2023 | Part 3: Requirements and testing for biological evaluation | GSPR 10.4 (Biocompatibility) | Current |
| EN ISO 10993-15:2023 | Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019) | GSPR 10.4 (Biocompatibility) | Current |
| EN ISO 10993-17:2023 | Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023) | GSPR 10.4 (Biocompatibility) | Current |
| EN ISO 10993-18:2020 + 2023 | Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020) | GSPR 10.4 (Biocompatibility) | Current |
| EN ISO 10993-4:2017 + 2025 | Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) | GSPR 10.4 (Biocompatibility) | Current |
Important: The following widely-used standards are not on the EU MDR harmonised standards list and do not create a presumption of conformity: EN ISO 10993-1 (evaluation framework), EN ISO 10993-3 (genotoxicity), EN ISO 10993-5 (cytotoxicity), EN ISO 10993-6 (implantation), EN ISO 10993-7 (EO residuals), EN ISO 10993-11 (systemic toxicity), EN ISO 10993-13 (polymers). They remain industry-accepted evaluation methods but must be justified separately in the technical file.
Biocompatibility Evaluation Framework
Material characterisation → Hazard identification → Exposure assessment → Toxicological risk assessment → Biocompatibility conclusion
Under EU MDR, chemical characterisation takes priority: toxicological risk assessment (TRA) is performed first; animal testing is only conducted when TRA is insufficient to reach a conclusion.