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/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

    from 150.80 EUR VAT included

    from 140.93 EUR VAT excluded

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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)

    from 166.83 EUR VAT included

    from 155.92 EUR VAT excluded

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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.

    Draft standard

    PR NF S98-103-1; PR NF EN ISO 11137-1 - Draft

    Sterilization of health care products - Radiation - Part 1 : requirements for development, validation and routine control of a sterilization process for medical devices.

    180.40 EUR VAT included

    168.60 EUR VAT excluded

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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

    from 424.00 EUR VAT included

    from 396.26 EUR VAT excluded

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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

    from 171.40 EUR VAT included

    from 160.19 EUR VAT excluded

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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

    from 443.50 EUR VAT included

    from 414.49 EUR VAT excluded

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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

    from 262.10 EUR VAT included

    from 244.95 EUR VAT excluded

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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

    from 211.70 EUR VAT included

    from 197.85 EUR VAT excluded

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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

    from 299.00 EUR VAT included

    from 279.44 EUR VAT excluded

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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

    from 262.10 EUR VAT included

    from 244.95 EUR VAT excluded

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