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11.100.20 Biologické hodnocení zdravotnických prostředků
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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
Vydáno: 2024-06-20
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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
Vydáno: 2024-05-21
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BS EN ISO 10993-18:2020+A1:2023
Biological evaluation of medical devices Chemical characterization of medical device materials within a risk management process
Biological evaluation of medical devices Chemical characterization of medical device materials within a risk management process
Vydáno: 2023-07-27
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BS EN ISO 10993-9:2021
Biological evaluation of medical devices Framework for identification and quantification of potential degradation products
Biological evaluation of medical devices Framework for identification and quantification of potential degradation products
Vydáno: 2022-05-19
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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
Vydáno: 2024-03-11
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BS EN ISO 10993-17:2023 - TC
Tracked Changes. Biological evaluation of medical devices Toxicological risk assessment of medical device constituents
Tracked Changes. Biological evaluation of medical devices Toxicological risk assessment of medical device constituents
Vydáno: 2023-12-20
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BS EN ISO 10993-7:2008+A1:2022
Biological evaluation of medical devices Ethylene oxide sterilization residuals
Biological evaluation of medical devices Ethylene oxide sterilization residuals
Vydáno: 2022-01-26
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BS EN ISO 10993-1:2020 - TC
Tracked Changes. Biological evaluation of medical devices Evaluation and testing within a risk management process
Tracked Changes. Biological evaluation of medical devices Evaluation and testing within a risk management process
Vydáno: 2020-12-21
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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
Vydáno: 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
Vydáno: 2023-02-08
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