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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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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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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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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
Vydáno: 2025-12-08
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BS EN ISO 10993-5:2009+A11:2025
Biological evaluation of medical devices Tests for in vitro cytotoxicity
Biological evaluation of medical devices Tests for in vitro cytotoxicity
Vydáno: 2025-03-17
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BS EN ISO 10993-3 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
BS EN ISO 10993-3 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Vydáno: 2025-04-04
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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
Vydáno: 2017-01-31
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BS EN ISO 10993-13:2010
Biological evaluation of medical devices Identification and quantification of degradation products from polymeric medical devices
Biological evaluation of medical devices Identification and quantification of degradation products from polymeric medical devices
Vydáno: 2010-10-31
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