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  1. ISO/TC 194 Biologische Beurteilung von Medizinprodukten, ISO/TC 194 Biological evaluation of medical devices, ISO/TC 194 Évaluation biologique des dispositifs médicaux, ISO Internationale Organisation für Normung, ISO International Organization for Standardization, ISO Organisation Internationale de Normalisation

    ISO 10993-4 DAM 1 : Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 - [2024-03-00]

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    Geneve: International Organization for Standardization, 2024

    Published in: ISO-Regelwerk- ISO-Normen

  2. ISO/TC 194 Biologische Beurteilung von Medizinprodukten, ISO/TC 194 Biological evaluation of medical devices, ISO/TC 194 Évaluation biologique des dispositifs médicaux, ISO Internationale Organisation für Normung, ISO International Organization for Standardization, ISO Organisation Internationale de Normalisation

    ISO 10993-17 : Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - [2023-09-00]

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    Geneve: International Organization for Standardization, 2023

    Published in: ISO-Regelwerk- ISO-Normen

  3. ISO/TC 194 Biologische Beurteilung von Medizinprodukten, ISO/TC 194 Biological evaluation of medical devices, ISO/TC 194 Évaluation biologique des dispositifs médicaux, ISO Internationale Organisation für Normung, ISO International Organization for Standardization, ISO Organisation Internationale de Normalisation

    ISO/TR 10993-55 : Biological evaluation of medical devices - Part 55: Interlaboratory study on cytotoxicity - [2023-02-00]

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    Geneve: International Organization for Standardization, 2023

    Published in: ISO-Regelwerk- ISO-Normen

  4. ISO/TC 194 Biologische Beurteilung von Medizinprodukten, ISO/TC 194 Biological evaluation of medical devices, ISO/TC 194 Évaluation biologique des dispositifs médicaux, ISO Internationale Organisation für Normung, ISO International Organization for Standardization, ISO Organisation Internationale de Normalisation

    ISO/TS 11796 : Biological evaluation of medical devices - Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices - [2023-07-00]

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    Geneve: International Organization for Standardization, 2023

    Published in: ISO-Regelwerk- ISO-Normen

  5. ISO/TC 194 Biologische Beurteilung von Medizinprodukten, ISO/TC 194 Biological evaluation of medical devices, ISO/TC 194 Évaluation biologique des dispositifs médicaux, ISO Internationale Organisation für Normung, ISO International Organization for Standardization, ISO Organisation Internationale de Normalisation

    ISO 10993-18 AMD 1 : Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor - [2022-05-00]

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    Geneve: International Organization for Standardization, 2022

    Published in: ISO-Regelwerk- ISO-Normen

  6. ISO/TC 194 Biologische Beurteilung von Medizinprodukten, ISO/TC 194 Biological evaluation of medical devices, ISO/TC 194 Évaluation biologique des dispositifs médicaux, ISO Internationale Organisation für Normung, ISO International Organization for Standardization, ISO Organisation Internationale de Normalisation

    ISO 10993-2 : Biological evaluation of medical devices - Part 2: Animal welfare requirements - [2022-11-00]

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    Geneve: International Organization for Standardization, 2022

    Published in: ISO-Regelwerk- ISO-Normen

  7. ISO/TC 194 Biologische Beurteilung von Medizinprodukten, ISO/TC 194 Biological evaluation of medical devices, ISO/TC 194 Évaluation biologique des dispositifs médicaux, ISO Internationale Organisation für Normung, ISO International Organization for Standardization, ISO Organisation Internationale de Normalisation

    ISO 10993-10 : Biological evaluation of medical devices - Part 10: Tests for skin sensitization - [2021-11-00]

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    Geneve: International Organization for Standardization, 2021

    Published in: ISO-Regelwerk- ISO-Normen

  8. ISO/TC 194 Biologische Beurteilung von Medizinprodukten, ISO/TC 194 Biological evaluation of medical devices, ISO/TC 194 Évaluation biologique des dispositifs médicaux, ISO Internationale Organisation für Normung, ISO International Organization for Standardization, ISO Organisation Internationale de Normalisation

    ISO 10993-12 : Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - [2021-01-00]

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    Geneve: International Organization for Standardization, 2021

    Published in: ISO-Regelwerk- ISO-Normen

  9. ISO/TC 194 Biologische Beurteilung von Medizinprodukten, ISO/TC 194 Biological evaluation of medical devices, ISO/TC 194 Évaluation biologique des dispositifs médicaux, ISO Internationale Organisation für Normung, ISO International Organization for Standardization, ISO Organisation Internationale de Normalisation

    ISO 10993-23 : Biological evaluation of medical devices - Part 23: Tests for irritation - [2021-01-00]

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    Geneve: International Organization for Standardization, 2021

    Published in: ISO-Regelwerk- ISO-Normen

  10. ISO/TC 194 Biologische Beurteilung von Medizinprodukten, ISO/TC 194 Biological evaluation of medical devices, ISO/TC 194 Évaluation biologique des dispositifs médicaux, ISO Internationale Organisation für Normung, ISO International Organization for Standardization, ISO Organisation Internationale de Normalisation

    ISO/TR 21582 : Pyrogenicity - Principles and methods for pyrogen testing of medical devices - [2021-07-00]

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    Geneve: International Organization for Standardization, 2021

    Published in: ISO-Regelwerk- ISO-Normen

  11. ISO/TC 194 Biologische Beurteilung von Medizinprodukten, ISO/TC 194 Biological evaluation of medical devices, ISO/TC 194 Évaluation biologique des dispositifs médicaux, ISO Internationale Organisation für Normung, ISO International Organization for Standardization, ISO Organisation Internationale de Normalisation

    ISO/TS 37137-1 : Biological evaluation of absorbable medical devices - Part 1: General requirements - [2021-03-00]

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    Geneve: International Organization for Standardization, 2021

    Published in: ISO-Regelwerk- ISO-Normen

  12. ISO/TC 194 Biologische Beurteilung von Medizinprodukten, ISO/TC 194 Biological evaluation of medical devices, ISO/TC 194 Évaluation biologique des dispositifs médicaux, ISO Internationale Organisation für Normung, ISO International Organization for Standardization, ISO Organisation Internationale de Normalisation

    ISO 10993-18 : Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - [2020-01-00]

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    Geneve: International Organization for Standardization, 2020

    Published in: ISO-Regelwerk- ISO-Normen

  13. ISO/TC 194 Biologische Beurteilung von Medizinprodukten, ISO/TC 194 Biological evaluation of medical devices, ISO/TC 194 Évaluation biologique des dispositifs médicaux, ISO Internationale Organisation für Normung, ISO International Organization for Standardization, ISO Organisation Internationale de Normalisation

    ISO 14155 : Clinical investigation of medical devices for human subjects - Good clinical practice - [2020-07-00]

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    Geneve: International Organization for Standardization, 2020

    Published in: ISO-Regelwerk- ISO-Normen

  14. ISO/TC 194 Biologische Beurteilung von Medizinprodukten, ISO/TC 194 Biological evaluation of medical devices, ISO/TC 194 Évaluation biologique des dispositifs médicaux, ISO Internationale Organisation für Normung, ISO International Organization for Standardization, ISO Organisation Internationale de Normalisation

    ISO 22442-1 : Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management - [2020-09-00]

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    Geneve: International Organization for Standardization, 2020

    Published in: ISO-Regelwerk- ISO-Normen

  15. ISO/TC 194 Biologische Beurteilung von Medizinprodukten, ISO/TC 194 Biological evaluation of medical devices, ISO/TC 194 Évaluation biologique des dispositifs médicaux, ISO Internationale Organisation für Normung, ISO International Organization for Standardization, ISO Organisation Internationale de Normalisation

    ISO 22442-2 : Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling - [2020-09-00]

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    Geneve: International Organization for Standardization, 2020

    Published in: ISO-Regelwerk- ISO-Normen

  16. ISO/TC 194 Biologische Beurteilung von Medizinprodukten, ISO/TC 194 Biological evaluation of medical devices, ISO/TC 194 Évaluation biologique des dispositifs médicaux, ISO Internationale Organisation für Normung, ISO International Organization for Standardization, ISO Organisation Internationale de Normalisation

    ISO/TS 10993-19 : Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials - [2020-03-00]

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    Geneve: International Organization for Standardization, 2020

    Published in: ISO-Regelwerk- ISO-Normen

  17. ISO/TC 194 Biologische Beurteilung von Medizinprodukten, ISO/TC 194 Biological evaluation of medical devices, ISO/TC 194 Évaluation biologique des dispositifs médicaux, ISO Internationale Organisation für Normung, ISO International Organization for Standardization, ISO Organisation Internationale de Normalisation

    ISO 10993-15 : Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys - [2019-11-00]

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    Geneve: International Organization for Standardization, 2019

    Published in: ISO-Regelwerk- ISO-Normen

  18. ISO/TC 194 Biologische Beurteilung von Medizinprodukten, ISO/TC 194 Biological evaluation of medical devices, ISO/TC 194 Évaluation biologique des dispositifs médicaux, ISO Internationale Organisation für Normung, ISO International Organization for Standardization, ISO Organisation Internationale de Normalisation

    ISO 10993-7 AMD 1 : Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants - [2019-12-00]

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    Geneve: International Organization for Standardization, 2019

    Published in: ISO-Regelwerk- ISO-Normen

  19. ISO/TC 194 Biologische Beurteilung von Medizinprodukten, ISO/TC 194 Biological evaluation of medical devices, ISO/TC 194 Évaluation biologique des dispositifs médicaux, ISO Internationale Organisation für Normung, ISO International Organization for Standardization, ISO Organisation Internationale de Normalisation

    ISO 10993-9 : Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products - [2019-11-00]

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    Geneve: International Organization for Standardization, 2019

    Published in: ISO-Regelwerk- ISO-Normen

  20. ISO/TC 194 Biologische Beurteilung von Medizinprodukten, ISO/TC 194 Biological evaluation of medical devices, ISO/TC 194 Évaluation biologique des dispositifs médicaux, ISO Internationale Organisation für Normung, ISO International Organization for Standardization, ISO Organisation Internationale de Normalisation

    ISO/TS 21726 : Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents - [2019-02-00]

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    Geneve: International Organization for Standardization, 2019

    Published in: ISO-Regelwerk- ISO-Normen