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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 18113-2:2024 - TC Tracked Changes. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for professional use
immediate downloadReleased: 2024-06-14
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

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

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Standard number:BS EN ISO 18113-2:2024 - TC
Pages:60
Released:2024-06-14
ISBN:978 0 539 32308 5
Status:Tracked Changes
DESCRIPTION

BS EN ISO 18113-2:2024 - TC


This standard BS EN ISO 18113-2:2024 - 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) reagents, calibrators and controls intended for professional use. This document can also be applicable to accessories. This document is applicable to the labels for outer and immediate containers and to the instructions for use. This document does not apply to: a) IVD instruments or equipment; b) IVD reagents for self-testing.
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