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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
sklademVydáno: 2024-07-31
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

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

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Označení normy:BS EN ISO 18113-5:2024
Počet stran:24
Vydáno:2024-07-31
ISBN:978 0 539 13482 7
Status:Standard
DESCRIPTION

BS EN ISO 18113-5:2024


This standard BS EN ISO 18113-5:2024 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) is classified in these ICS categories:
  • 11.100.10 In vitro diagnostic test systems
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing. This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing. This document can also be applicable to accessories. This document does not apply to: a) instructions for instrument servicing or repair; b) IVD reagents, including calibrators and control materials for use in control of the reagent; c) IVD instruments for professional use.
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