Medizintechnik

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  • Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2024

    Standard [CURRENT] 2024-09

    DIN EN 556-1:2024-09

    Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2024

    from 72.60 EUR VAT included

    from 67.85 EUR VAT excluded

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  • Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2024

    Standard [CURRENT] 2025-01

    DIN EN 556-2:2025-01

    Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2024

    from 87.90 EUR VAT included

    from 82.15 EUR VAT excluded

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  • Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2025); German and English version prEN ISO 11135:2025

    Draft standard 2025-08

    DIN EN ISO 11135:2025-08 - Draft

    Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2025); German and English version prEN ISO 11135:2025

    from 238.30 EUR VAT included

    from 222.71 EUR VAT excluded

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  • Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013 + Amd 1:2022); German version EN ISO 11137-2:2015 + A1:2023

    Standard [CURRENT] 2023-08

    DIN EN ISO 11137-2:2023-08

    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013 + Amd 1:2022); German version EN ISO 11137-2:2015 + A1:2023

    from 203.40 EUR VAT included

    from 190.09 EUR VAT excluded

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  • Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017); German version EN ISO 11137-3:2017

    Standard [CURRENT] 2017-11

    DIN EN ISO 11137-3:2017-11

    Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017); German version EN ISO 11137-3:2017

    An integral part of radiation sterilization is the ability to measure dose. Dose is measured during all stages of development, validation and routine monitoring of the sterilization process.

    from 139.20 EUR VAT included

    from 130.09 EUR VAT excluded

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  • Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020); German version CEN ISO/TS 11137-4:2023

    Pre-standard 2023-10

    DIN CEN ISO/TS 11137-4:2023-10

    Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020); German version CEN ISO/TS 11137-4:2023

    Procedure : Pre-Standard

    from 134.60 EUR VAT included

    from 125.79 EUR VAT excluded

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  • Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards (ISO 11139:2018 + Amd 1:2024); German and English version EN ISO 11139:2018 + A1:2024

    Standard [CURRENT] 2024-06

    DIN EN ISO 11139:2024-06

    Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards (ISO 11139:2018 + Amd 1:2024); German and English version EN ISO 11139:2018 + A1:2024

    from 222.60 EUR VAT included

    from 208.04 EUR VAT excluded

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  • Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDₘₐₓSD (ISO 13004:2022); German version EN ISO 13004:2023

    Standard [CURRENT] 2023-10

    DIN EN ISO 13004:2023-10

    Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDₘₐₓSD (ISO 13004:2022); German version EN ISO 13004:2023

    from 168.30 EUR VAT included

    from 157.29 EUR VAT excluded

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  • Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023); German version EN ISO 13408-1:2024

    Standard [CURRENT] 2024-09

    DIN EN ISO 13408-1:2024-09

    Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023); German version EN ISO 13408-1:2024

    from 203.40 EUR VAT included

    from 190.09 EUR VAT excluded

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  • Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021); German version EN ISO 17664-1:2021

    Standard [CURRENT] 2021-11

    DIN EN ISO 17664-1:2021-11

    Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021); German version EN ISO 17664-1:2021

    from 115.70 EUR VAT included

    from 108.13 EUR VAT excluded

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