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)

    Standard [NEW] 2026-09-15

    OENORM EN ISO 11137-1:2026-09-15

    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)

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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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  • Guidance on transferring health care products between radiation sterilization sources

    Technical rule [CURRENT] 2022

    AAMI TIR 104:2022

    Guidance on transferring health care products between radiation sterilization sources

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  • Standard Guide for Performance Qualification (PQ) Dose Mapping in Gamma Irradiation Processing Facilities

    Standard [CURRENT] 2025

    ASTM E 3464:2025

    Standard Guide for Performance Qualification (PQ) Dose Mapping in Gamma Irradiation Processing Facilities

    1.1 In this standard, guidance is provided on the procedure for conducting performance qualification (PQ) dose mapping at gamma irradiation facilities. Note 1: For irradiation of health care and ...

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