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11.100.10 Systémy diagnostických zkoušek in vitro

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BS EN ISO 18113-4:2024 - TC
Tracked Changes. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for self-testing

Vydáno: 2024-06-14

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BS EN ISO 18113-4:2024
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for self-testing

Vydáno: 2024-06-12

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BS EN ISO 18113-3:2024 - TC
Tracked Changes. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic instruments for professional use

Vydáno: 2024-06-14

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BS EN ISO 18113-5:2024
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) Part 5: In vitro diagnostic instruments for self-testing

Vydáno: 2024-07-31

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BS EN ISO 15194:2009
In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for certified reference materials and the content of supporting documentation

Vydáno: 2016-01-31

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PD CEN/TS 17747:2022
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood. DNA, RNA and proteins

Vydáno: 2022-05-26

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BS ISO 21474-2:2022
In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids Validation and verification

Vydáno: 2022-05-17

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BS EN ISO 17511:2021
In vitro diagnostic medical devices. Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

Vydáno: 2021-06-07

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PD CEN/TS 17688-1:2021
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) Isolated cellular RNA

Vydáno: 2021-12-23

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BS EN ISO 5649:2024
Medical laboratories. Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests

Vydáno: 2024-12-13

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PD CEN ISO/TS 7552-2:2024 - TC
Tracked Changes. Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood Isolated DNA

Vydáno: 2024-12-04

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PD CEN ISO/TS 7552-3:2024 - TC
Tracked Changes. Molecular in vitro diagnostic examinations Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood Preparations for analytical CTC staining

Vydáno: 2024-12-11

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76 results

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