Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables

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Medical devices. Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substance

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Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials

NEPLATNÁ vydaná dňa 1.9.2010

Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials

NEPLATNÁ vydaná dňa 1.1.2013

Medical devices. Biological evaluation of medical devices. Part 19. Tests physico-chemical, morphological and topographical characterization of materials

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Standardization in the Russian Federation. Medical devices. Biological evaluation of medical devices. Part 2. Animal welfare requirements

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Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices

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Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity

NEPLATNÁ vydaná dňa 1.7.2010

Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity

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Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood

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