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11.100.20 Biologické hodnocení zdravotnických prostředků
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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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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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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 7405:2018
Dentistry. Evaluation of biocompatibility of medical devices used in dentistry
Dentistry. Evaluation of biocompatibility of medical devices used in dentistry
Vydáno: 2018-11-28
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BS EN ISO 10993-11:2018
Biological evaluation of medical devices Tests for systemic toxicity
Biological evaluation of medical devices Tests for systemic toxicity
Vydáno: 2022-02-02
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BS EN ISO 10993-16:2017
Biological evaluation of medical devices Toxicokinetic study design for degradation products and leachables
Biological evaluation of medical devices Toxicokinetic study design for degradation products and leachables
Vydáno: 2020-03-30
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BS EN ISO 10993-6:2016
Biological evaluation of medical devices Tests for local effects after implantation
Biological evaluation of medical devices Tests for local effects after implantation
Vydáno: 2016-12-31
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PD ISO/TR 21582:2021
Pyrogenicity. Principles and methods for pyrogen testing of medical devices
Pyrogenicity. Principles and methods for pyrogen testing of medical devices
Vydáno: 2021-07-28
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BS EN ISO 22442-2:2020
Medical devices utilizing animal tissues and their derivatives Controls on sourcing, collection and handling
Medical devices utilizing animal tissues and their derivatives Controls on sourcing, collection and handling
Vydáno: 2020-12-14
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BS EN ISO 10993-12:2021 - TC
Tracked Changes. Biological evaluation of medical devices Sample preparation and reference materials
Tracked Changes. Biological evaluation of medical devices Sample preparation and reference materials
Vydáno: 2021-11-16
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