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11.100.10 Systémy diagnostických zkoušek in vitro

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BS EN 13975:2003
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects

Vydáno: 2003-03-28

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BS EN 13532:2002
General requirements for in vitro diagnostic medical devices for self-testing

Vydáno: 2002-05-08

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BS EN ISO 20166-3:2019
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue Isolated DNA

Vydáno: 2019-01-28

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BS EN ISO 18153:2003
In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials

Vydáno: 2003-08-19

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PD CEN/TS 17688-3:2021
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) Isolated genomic DNA

Vydáno: 2021-12-23

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BS ISO 21474-1:2020
In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids Terminology and general requirements for nucleic acid quality evaluation

Vydáno: 2020-08-24

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BS EN ISO 15197:2015
In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

Vydáno: 2015-06-30

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BS EN IEC 61326-2-6:2021
Electrical equipment for measurement, control and laboratory use. EMC requirements Particular requirements. In vitro diagnostic (IVD) medical equipment

Vydáno: 2021-06-08

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BS EN ISO 20184-2:2018
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue Isolated proteins

Vydáno: 2019-02-22

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24/30463721 DC
BS EN ISO 15194 In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation

Vydáno: 2023-12-26

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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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