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UNE - Spanish national standards
Page 126
UNE-EN ISO 10993-2:2023 (12/07/2023)
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
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UNE-EN ISO 10993-23:2021 (13/10/2021)
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
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UNE-EN ISO 10993-23:2021/A1:2026 (06/05/2026) Change
Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1: Additional in vitro reconstructed human epidermis models (ISO 10993-23:2021/Amd 1:2025)
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UNE-EN ISO 10993-3:2015 (06/05/2015)
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
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UNE-EN ISO 10993-4:2018 (24/01/2018)
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
Available languages: English, Spanish
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UNE-EN ISO 10993-4:2018/A1:2025 (22/10/2025) Change
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/Amd 1:2025, Corrected version 2025-04)
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UNE-EN ISO 10993-5:2009 (09/12/2009)
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
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UNE-EN ISO 10993-5:2009/A11:2025 (22/10/2025) Change
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
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UNE-EN ISO 10993-6:2017 (25/10/2017)
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
Available languages: English, Spanish
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UNE-EN ISO 10993-7:2009 (03/06/2009)
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
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