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

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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

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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

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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.

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    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

    In 2012, CEN/TC 102 "Sterilizers and associated equipment for processing of medical devices" (secretariat: DIN, Germany), CEN/TC 204 "Sterilization of medical devices" (secretariat: BSI, Great ...

    from 222.60 EUR VAT included

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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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