Harmonised Standards — Biocompatibility
Official Source: EC Health — Harmonised Standards | Based on CID (EU) 2021/1182 (consolidated) and latest amendment CID (EU) 2026/1231
Harmonised Standards List (10)
| Standard No. | Title Summary | GSPR Reference | Status |
|---|---|---|---|
| EN ISO 10993-1:2025 | Part 1: Requirements and general principles for evaluation of biological safety within a risk management process | GSPR 10.4 (Biocompatibility) | Active 🆕 |
| EN ISO 10993-4:2017 + A1:2025 | Part 4: Selection of tests for interactions with blood | GSPR 10.4 (Biocompatibility) | Active |
| EN ISO 10993-5:2009 + A11:2025 | Part 5: Tests for in vitro cytotoxicity | GSPR 10.4 (Biocompatibility) | Active 🆕 |
| EN ISO 10993-9:2021 | Part 9: Framework for identification and quantification of potential degradation products | GSPR 10.4 (Biocompatibility) | Active |
| EN ISO 10993-10:2023 | Part 10: Tests for skin sensitisation | GSPR 10.4 (Biocompatibility) | Active |
| EN ISO 10993-12:2021 + A1:2025 | Part 12: Sample preparation and reference materials | GSPR 10.4 (Biocompatibility) | Active |
| EN ISO 10993-15:2023 | Part 15: Identification and quantification of degradation products from metals and alloys | GSPR 10.4 (Biocompatibility) | Active |
| EN ISO 10993-17:2023 + A1:2025 | Part 17: Toxicological risk assessment of medical device constituents | GSPR 10.4 (Biocompatibility) | Active |
| EN ISO 10993-18:2020 + A1:2023 | Part 18: Chemical characterization of medical device materials within a risk management process | GSPR 10.4 (Biocompatibility) | Active |
| EN ISO 10993-23:2021 + A1:2025 | Part 23: Tests for irritation | GSPR 10.4 (Biocompatibility) | Active |
June 2026 Update
CID (EU) 2026/1231 (11 June 2026) newly harmonised EN ISO 10993-1:2025 and EN ISO 10993-5:2009/A11:2025, and added A1:2025 amendments to Parts 12, 17, and 23.
Important Note: The following widely-used standards are NOT currently in the harmonised list and do not confer presumption of conformity: EN ISO 10993-3 (genotoxicity), EN ISO 10993-6 (implantation), EN ISO 10993-7 (EO residuals), EN ISO 10993-11 (systemic toxicity), EN ISO 10993-13 (polymer degradation).
Biocompatibility Evaluation Framework (ISO 10993-1:2025)
Material Characterization -> Hazard Identification -> Exposure Assessment -> Toxicological Risk Assessment -> Biocompatibility Conclusion
Under EU MDR, chemical characterization takes priority: perform TRA first; conduct animal testing only when TRA alone is insufficient.
Related Pages
Data Source
eu_mdr/standards/standards-biocompatibility.json