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11.100.20 Biological evaluation of medical devices
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PD ISO/TR 15499:2016 - TC
Tracked Changes. Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
Tracked Changes. Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
Released: 2020-02-26
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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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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 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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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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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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