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11.100.20 Biological evaluation of medical devices
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PD ISO/TR 10993-33:2015
Biological evaluation of medical devices Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3
Biological evaluation of medical devices Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3
Released: 2015-03-31
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506.24 EUR
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25/30482510 DC
BS EN ISO 10993-16 Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables
BS EN ISO 10993-16 Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables
Released: 2025-12-08
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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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24/30475247 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 10993-23:2021+A1:2025
Biological evaluation of medical devices Tests for irritation
Biological evaluation of medical devices Tests for irritation
Released: 2025-11-04
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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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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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24/30482475 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 10993-22:2017
Biological evaluation of medical devices Guidance on nanomaterials
Biological evaluation of medical devices Guidance on nanomaterials
Released: 2017-07-19
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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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DD ISO/TS 10993-20:2006
Biological evaluation of medical devices Principles and methods for immunotoxicology testing of medical devices
Biological evaluation of medical devices Principles and methods for immunotoxicology testing of medical devices
Released: 2006-09-29
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