Medizintechnik

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  • Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2025); German version EN ISO 11137-1:2026

    Standard [AVAILABLE PRE-PUBLICATION] 2026-10

    DIN EN ISO 11137-1:2026-10

    Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2025); German version EN ISO 11137-1:2026

    And replaced by 2026-10 for: DIN EN ISO 11137-1:2020-04 , DIN EN ISO 11137-1:2023-05

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  • Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023); German and English version prEN ISO 11137-1:2023

    Draft standard 2023-05

    DIN EN ISO 11137-1:2023-05 - Draft

    Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023); German and English version prEN ISO 11137-1:2023

    DIN EN ISO 11137-1:2026-10

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  • Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023)

    Draft standard 2023-05-15

    OENORM EN ISO 11137-1:2023-05-15 - Draft

    Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023)

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  • Active airborne microorganism inactivation by Germicidal Ultraviolet (GUV) luminaires

    Draft standard 2026-04-17

    PR NF EN IEC 63533:2026-04-17 - Draft

    Active airborne microorganism inactivation by Germicidal Ultraviolet (GUV) luminaires

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  • Sterilization of health care products. Radiation. Establishing the sterilization dose

    Standard [CURRENT] 2015-06-30

    BS EN ISO 11137-2+A1:2015-06-30

    Sterilization of health care products. Radiation. Establishing the sterilization dose

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  • Guidance on radiation validation and routine maintenance for single-use systems used for pharmaceutical and biopharmaceutical manufacturing

    Technical rule [CURRENT] 2024

    AAMI CR 513:2024

    Guidance on radiation validation and routine maintenance for single-use systems used for pharmaceutical and biopharmaceutical manufacturing

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  • Chemical sterilization and high-level disinfection in health care facilities

    Standard [CURRENT] 2024

    AAMI ST 58:2024

    Chemical sterilization and high-level disinfection in health care facilities

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  • Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits

    Technical rule [CURRENT] 2016

    AAMI TIR 35:2016

    Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits

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  • Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2

    Technical rule [CURRENT] 2018

    AAMI TIR 40:2018

    Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2

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  • Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose at a specified sterility assurance level: Method VDmax SD-S

    Technical rule [CURRENT] 2021

    AAMI TIR 76:2021

    Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose at a specified sterility assurance level: Method VDmax SD-S

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