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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 22442-1:2020
Medical devices utilizing animal tissues and their derivatives Application of risk management
Medical devices utilizing animal tissues and their derivatives Application of risk management
Vydáno: 2020-12-14
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PD ISO/TS 16782:2016
Clinical laboratory testing. Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
Clinical laboratory testing. Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
Vydáno: 2016-11-30
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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 10993-3:2014
Biological evaluation of medical devices Tests for genotoxicity, carcinogenicity and reproductive toxicity
Biological evaluation of medical devices Tests for genotoxicity, carcinogenicity and reproductive toxicity
Vydáno: 2014-10-31
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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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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 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 10993-6 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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