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>BSI Standards >11 HEALTH CARE TECHNOLOGY>11.100 Laboratory medicine>11.100.10 In vitro diagnostic test systems>BS EN ISO 18113-5:2024 - TC Tracked Changes. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic instruments for self-testing
immediate downloadReleased: 2024-06-14
BS EN ISO 18113-5:2024 - TC Tracked Changes. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic instruments for self-testing

BS EN ISO 18113-5:2024 - TC

Tracked Changes. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic instruments for self-testing

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Standard number:BS EN ISO 18113-5:2024 - TC
Pages:50
Released:2024-06-14
ISBN:978 0 539 32311 5
Status:Tracked Changes
DESCRIPTION

BS EN ISO 18113-5:2024 - TC


This standard BS EN ISO 18113-5:2024 - TC Tracked Changes. 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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