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BS EN ISO 10993-7:2008+A1:2022 - TC
Tracked Changes. Biological evaluation of medical devices Ethylene oxide sterilization residuals
Tracked Changes. Biological evaluation of medical devices Ethylene oxide sterilization residuals
Released: 2022-05-19
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24/30453873 DC
BS EN ISO 10993-6 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
BS EN ISO 10993-6 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
Released: 2024-05-21
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24/30467406 DC
BS EN ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice
BS EN ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice
Released: 2024-06-20
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24/30475247 DC
BS EN ISO 10993-4:2017/Amd 1 Biological evaluation of medical devices Part 4. Selection of tests for interactions with blood. Amendment 1
BS EN ISO 10993-4:2017/Amd 1 Biological evaluation of medical devices Part 4. Selection of tests for interactions with blood. Amendment 1
Released: 2024-03-11
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BS EN ISO 7405:2025 - TC
Tracked Changes. Dentistry. Evaluation of biocompatibility of medical devices used in dentistry
Tracked Changes. Dentistry. Evaluation of biocompatibility of medical devices used in dentistry
Released: 2025-07-09
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BS EN ISO 10993-23:2021+A1:2025
Biological evaluation of medical devices Tests for irritation
Biological evaluation of medical devices Tests for irritation
Released: 2025-09-04
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PD ISO/TR 10993-55:2023
Biological evaluation of medical devices Interlaboratory study on cytotoxicity
Biological evaluation of medical devices Interlaboratory study on cytotoxicity
Released: 2023-02-20
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BS EN ISO 10993-10:2023
Biological evaluation of medical devices Tests for skin sensitization
Biological evaluation of medical devices Tests for skin sensitization
Released: 2023-02-08
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BS EN ISO 10993-15:2023
Biological evaluation of medical devices Identification and quantification of degradation products from metals and alloys
Biological evaluation of medical devices Identification and quantification of degradation products from metals and alloys
Released: 2023-05-24
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24/30482475 DC
BS EN ISO 10993-2 Biological evaluation of medical devices Part 2: Animal welfare requirements
BS EN ISO 10993-2 Biological evaluation of medical devices Part 2: Animal welfare requirements
Released: 2024-11-11
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PD ISO/TR 15499:2016
Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
Released: 2017-01-31
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