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11.100.20 Biological evaluation of medical devices
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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
Released: 2022-05-19
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25/30482494 DC
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
Released: 2025-04-04
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BS EN ISO 14155:2020+A11:2024
Clinical investigation of medical devices for human subjects. Good clinical practice
Clinical investigation of medical devices for human subjects. Good clinical practice
Released: 2025-01-20
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BS EN ISO 10993-14:2009
Biological evaluation of medical devices Identification and quantification of degradation products from ceramics
Biological evaluation of medical devices Identification and quantification of degradation products from ceramics
Released: 2009-06-30
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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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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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PD ISO/TS 10993-19:2020
Biological evaluation of medical devices Physico-chemical, morphological and topographical characterization of materials
Biological evaluation of medical devices Physico-chemical, morphological and topographical characterization of materials
Released: 2020-03-16
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BS EN ISO 10993-6:2016 - TC
Tracked Changes. Biological evaluation of medical devices Tests for local effects after implantation
Tracked Changes. Biological evaluation of medical devices Tests for local effects after implantation
Released: 2020-02-24
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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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