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11.100.10 In vitro diagnostic test systems

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BS EN ISO 13079:2011
Laboratory glass and plastics ware. Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method

Released: 2011-08-31

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BS EN ISO 15193:2009
In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for content and presentation of reference measurement procedures

Released: 2016-01-31

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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

Released: 2016-01-31

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

Released: 2020-02-25

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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

Released: 2015-06-30

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BS EN ISO 16256:2021 - TC
Tracked Changes. Clinical laboratory testing and in vitro diagnostic test systems. Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases

Released: 2021-11-17

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BS EN ISO 16256:2021
Clinical laboratory testing and in vitro diagnostic test systems. Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases

Released: 2021-10-27

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

Released: 2021-12-10

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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

Released: 2021-06-07

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BS EN ISO 18113-1:2024 - TC
Tracked Changes. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions, and general requirements

Released: 2024-06-14

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BS EN ISO 18113-1:2024
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions, and general requirements

Released: 2024-06-12

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BS EN ISO 18113-2:2024 - TC
Tracked Changes. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for professional use

Released: 2024-06-14

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