Medizintechnik

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  • Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO/DIS 10993-1:2024); German and English version prEN ISO 10993-1:2024

    Draft standard 2024-07

    DIN EN ISO 10993-1:2024-07 - Draft

    Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO/DIS 10993-1:2024); German and English version prEN ISO 10993-1:2024

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  • Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10); German version EN ISO 10993-1:2020

    Standard [CURRENT] 2021-05

    DIN EN ISO 10993-1:2021-05

    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10); German version EN ISO 10993-1:2020

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  • Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO/DIS 10993-2:2024); German and English version prEN ISO 10993-2:2024

    Draft standard 2024-12

    DIN EN ISO 10993-2:2024-12 - Draft

    Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO/DIS 10993-2:2024); German and English version prEN ISO 10993-2:2024

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  • Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022); German version EN ISO 10993-2:2022

    Standard [CURRENT] 2023-02

    DIN EN ISO 10993-2:2023-02

    Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022); German version EN ISO 10993-2:2022

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  • Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity (ISO/DIS 10993-3:2025); German and English version prEN ISO 10993-3:2025

    Draft standard 2025-05

    DIN EN ISO 10993-3:2025-05 - Draft

    Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity (ISO/DIS 10993-3:2025); German and English version prEN ISO 10993-3:2025

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  • Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/DAM 1:2024); German and English version EN ISO 10993-4:2017/prA1:2024

    Draft standard 2024-04

    DIN EN ISO 10993-4/A1:2024-04 - Draft

    Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/DAM 1:2024); German and English version EN ISO 10993-4:2017/prA1:2024

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  • Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009

    Standard [CURRENT] 2009-10

    DIN EN ISO 10993-5:2009-10

    Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009

    This document has been modified by: DIN EN ISO 10993-5/A11:2025-05

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  • Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009/A11:2025

    Standard [NEW] 2025-05

    DIN EN ISO 10993-5/A11:2025-05

    Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009/A11:2025

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  • Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO/DIS 10993-6:2024); German and English version prEN ISO 10993-6:2024

    Draft standard 2024-06

    DIN EN ISO 10993-6:2024-06 - Draft

    Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO/DIS 10993-6:2024); German and English version prEN ISO 10993-6:2024

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  • Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016); German version EN ISO 10993-6:2016

    Standard [CURRENT] 2017-09

    DIN EN ISO 10993-6:2017-09

    Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016); German version EN ISO 10993-6:2016

    This standard DIN EN ISO 10993-6 has been adopted from the work of Technical Committee ISO/TC 194 "Biological and clinical evaluation of medical devices". It specifies test methods for the ...

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