Medizintechnik

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  • In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 1: Human DNA examination; German version CEN/TS 17981-1:2023

    Pre-standard 2024-05

    DIN CEN/TS 17981-1:2024-05

    In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 1: Human DNA examination; German version CEN/TS 17981-1:2023

    Procedure : Pre-Standard

    from 125.20 EUR VAT included

    from 117.01 EUR VAT excluded

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  • In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 2: Human RNA examination; German version CEN/TS 17981-2:2023

    Pre-standard 2024-05

    DIN CEN/TS 17981-2:2024-05

    In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 2: Human RNA examination; German version CEN/TS 17981-2:2023

    Procedure : Pre-Standard

    from 130.50 EUR VAT included

    from 121.96 EUR VAT excluded

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  • Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment (IEC 61010-2-101:2018, modified); German version EN IEC 61010-2-101:2022 + A11:2022

    Standard [CURRENT] 2023-12

    DIN EN IEC 61010-2-101:2023-12; VDE 0411-2-101:2023-12

    Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment (IEC 61010-2-101:2018, modified); German version EN IEC 61010-2-101:2022 + A11:2022

    86.36 EUR VAT included

    80.71 EUR VAT excluded

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  • Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment (IEC 65A/1174/FDIS:2025); German and English version FprEN IEC 61326-2-6:2025

    Draft standard 2025-07

    DIN EN IEC 61326-2-6:2025-07; VDE 0843-20-2-6:2025-07 - Draft

    Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment (IEC 65A/1174/FDIS:2025); German and English version FprEN IEC 61326-2-6:2025

    38.58 EUR VAT included

    36.06 EUR VAT excluded

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  • Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment (IEC 61326-2-6:2020); German version EN IEC 61326-2-6:2021

    Standard [CURRENT] 2022-11

    DIN EN IEC 61326-2-6:2022-11; VDE 0843-20-2-6:2022-11

    Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment (IEC 61326-2-6:2020); German version EN IEC 61326-2-6:2021

    55.94 EUR VAT included

    52.28 EUR VAT excluded

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  • Medical laboratories - Concepts and specifications for the design, development, implementation and use of laboratory-developed tests (ISO 5649:2024); German version EN ISO 5649:2024

    Standard [CURRENT] 2025-04

    DIN EN ISO 5649:2025-04

    Medical laboratories - Concepts and specifications for the design, development, implementation and use of laboratory-developed tests (ISO 5649:2024); German version EN ISO 5649:2024

    from 133.20 EUR VAT included

    from 124.49 EUR VAT excluded

    To selection
  • Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood - Part 1: Isolated RNA (ISO/TS 7552-1:2024); German version CEN ISO/TS 7552-1:2024

    Pre-standard 2025-03

    DIN CEN ISO/TS 7552-1:2025-03

    Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood - Part 1: Isolated RNA (ISO/TS 7552-1:2024); German version CEN ISO/TS 7552-1:2024

    Procedure : Pre-Standard

    from 87.80 EUR VAT included

    from 82.06 EUR VAT excluded

    To selection
  • Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood - Part 2: Isolated DNA (ISO/TS 7552-2:2024); German version CEN ISO/TS 7552-2:2024

    Pre-standard 2025-03

    DIN CEN ISO/TS 7552-2:2025-03

    Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood - Part 2: Isolated DNA (ISO/TS 7552-2:2024); German version CEN ISO/TS 7552-2:2024

    Procedure : Pre-Standard

    from 87.80 EUR VAT included

    from 82.06 EUR VAT excluded

    To selection
  • Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood - Part 3: Preparations for analytical CTC staining (ISO/TS 7552-3:2024); German version CEN ISO/TS 7552-3:2024

    Pre-standard 2025-03

    DIN CEN ISO/TS 7552-3:2025-03

    Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood - Part 3: Preparations for analytical CTC staining (ISO/TS 7552-3:2024); German version CEN ISO/TS 7552-3:2024

    Procedure : Pre-Standard

    from 75.60 EUR VAT included

    from 70.65 EUR VAT excluded

    To selection
  • In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023); German and English version prEN ISO 15193:2023

    Draft standard 2024-02

    DIN EN ISO 15193:2024-02 - Draft

    In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023); German and English version prEN ISO 15193:2023

    from 121.20 EUR VAT included

    from 113.27 EUR VAT excluded

    To selection
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