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Hlavní stránka>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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sklademVydáno: 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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Označení normy:BS EN ISO 18113-2:2024 - TC
Počet stran:60
Vydáno:2024-06-14
ISBN:978 0 539 32308 5
Status:Tracked Changes
Popis

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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