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11.100.20 Biologické hodnocení zdravotnických prostředků
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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
Vydáno: 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
Vydáno: 2023-02-08
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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
Vydáno: 2025-04-04
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BS EN ISO 10993-16 Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables
BS EN ISO 10993-16 Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables
Vydáno: 2025-12-08
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BS EN ISO 10993-5:2009+A11:2025
Biological evaluation of medical devices Tests for in vitro cytotoxicity
Biological evaluation of medical devices Tests for in vitro cytotoxicity
Vydáno: 2025-03-17
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BS EN ISO 14155:2026
Clinical investigation of medical devices for human subjects. Good clinical practice
Clinical investigation of medical devices for human subjects. Good clinical practice
Vydáno: 2026-04-22
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PD ISO/TR 15499:2016
Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
Vydáno: 2017-01-31
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BS EN ISO 18812:2003
Health informatics. Clinical analyser interfaces to laboratory information systems. Use profiles
Health informatics. Clinical analyser interfaces to laboratory information systems. Use profiles
Vydáno: 2003-06-24
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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
Vydáno: 2020-02-24
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