Biocompatibility - Related International Standards
The following non-harmonised international standards are related to Biocompatibility for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| ISO 10993-1:2025 | Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process | active | 10, 10.1, 10.4 | Link |
| ISO 10993-2:2022 | Biological evaluation of medical devices - Part 2: Animal welfare requirements | active | 10, 10.4 | Link |
| ISO 10993-6:2026 | Biological evaluation of medical devices - Part 6: Tests for local effects after implantation | active | 10, 10.4 | Link |
| ISO 10993-13:2010 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices | active | 10, 10.4 | Link |
| ISO 10993-14:2001 | Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics | active | 10, 10.4 | Link |
| ISO 10993-16:2017 | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables | active | 10, 10.4 | Link |
| ISO/TS 10993-19:2020 | Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials | active | 10, 10.4 | Link |
| ISO/TS 10993-20:2006 | Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices | active | 10, 10.4 | Link |
| ISO 10993-22:2017 | Biological evaluation of medical devices - Part 22: Guidance on nanomaterials | active | 10, 10.4 | Link |
| ISO 10993-3:2014 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014) | active | 10, 10.1, 10.4, 10.4.1 | Link |
| ISO 10993-7:2026 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals | active | 10, 10.1, 10.4, 10.4.2, 11 | Link |
| ISO 10993-11:2017 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | active | 10, 10.1, 10.4, 10.4.1, 10.6 | Link |
| ISO 22442-1:2020 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020) | active | 10, 10.4, 12, 13, 13.1, 13.2 | Link |
| ISO 22442-2:2020 | Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020) | active | 10, 10.4, 12, 13, 13.1, 13.2 | Link |
| ISO 22442-3:2007 | Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and TSE agents (ISO 22442-3:2007, Amd 1:2015) | active | 10, 10.4, 12, 13, 13.1, 13.2 | Link |
| ISO 10993-4:2017 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) | active | 10, 10.1, 10.4, 10.4.1 | Link |
| ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) | active | 10, 10.1, 10.4, 10.4.1 | Link |
| ISO 10993-9:2021 | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019) | active | 10, 10.1, 10.4, 10.4.2 | Link |
| ISO 10993-10:2023 | Biological evaluation of medical devices - Part 10: Tests for skin sensitisation (ISO 10993-10:2021) | active | 10, 10.1, 10.4, 10.4.1 | Link |
| ISO 10993-12:2021 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021) | active | 10, 10.2 | Link |
| ISO 10993-15:2019 | Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019) | active | 10, 10.1, 10.4, 10.4.2 | Link |
| ISO 10993-17:2023 | Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023) | active | 10, 10.1, 10.2, 10.4, 10.4.1, 10.4.2, 10.4.3, 10.4.4 | Link |
| ISO 10993-18:2020 | Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020) | active | 10, 10.1, 10.2, 10.4.1, 10.4.2, 10.5 | Link |
| ISO 10993-23:2021 | Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021) | active | 10, 10.1, 10.4, 10.4.1 | Link |