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11.100.20 Biological evaluation of medical devices
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181.70 EUR
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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 ISO 17593:2022
Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
Released: 2022-03-15
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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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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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24/30482502 DC
BS EN ISO 10993-17:2023/Amd 1 Biological evaluation of medical devices Part 17: Toxicological risk assessment of medical device constituents — Amendment
BS EN ISO 10993-17:2023/Amd 1 Biological evaluation of medical devices Part 17: Toxicological risk assessment of medical device constituents — Amendment
Released: 2024-07-31
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24/30451085 DC
BS EN ISO 10993-1 Biological evaluation of medical devices Part 1. Evaluation and testing within a risk management process
BS EN ISO 10993-1 Biological evaluation of medical devices Part 1. Evaluation and testing within a risk management process
Released: 2024-06-24
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24/30482506 DC
BS EN ISO 10993-12:2021/Amd 1 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
BS EN ISO 10993-12:2021/Amd 1 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
Released: 2024-06-19
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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
Released: 2023-12-20
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