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Standards Worldwide
Standards Worldwide
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Medizintechnik

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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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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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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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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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Draft standard 2024-02

DIN EN ISO 5649:2024-02 - Draft
Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests (ISO/DIS 5649:2023); German and English version prEN ISO 5649:2023

from 133.20 EUR VAT included

from 124.49 EUR VAT excluded

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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

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Draft standard 2024-02

DIN EN ISO 15194:2024-02 - Draft
In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2023); German and English version prEN ISO 15194:2023

from 115.70 EUR VAT included

from 108.13 EUR VAT excluded

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Standard [CURRENT] 2024-10

DIN EN ISO 18113-1:2024-10
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022); German version EN ISO 18113-1:2024

from 174.20 EUR VAT included

from 162.80 EUR VAT excluded

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Standard [CURRENT] 2024-10

DIN EN ISO 18113-2:2024-10
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022); German version EN ISO 18113-2:2024

from 94.60 EUR VAT included

from 88.41 EUR VAT excluded

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Standard [CURRENT] 2024-10

DIN EN ISO 18113-3:2024-10
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2022); German version EN ISO 18113-3:2024

from 94.60 EUR VAT included

from 88.41 EUR VAT excluded

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