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11.100.20 Biologické hodnocení zdravotnických prostředků
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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
Vydáno: 2020-03-16
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BS EN ISO 10993-23:2021
Biological evaluation of medical devices Tests for irritation
Biological evaluation of medical devices Tests for irritation
Vydáno: 2021-04-09
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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
Vydáno: 2009-06-30
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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 10993-18:2020+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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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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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
Vydáno: 2024-06-19
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24/30467406 DC
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 10993-17:2023 - 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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24/30453873 DC
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 10993-13:2010
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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