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Hlavní stránka>BS EN ISO 18113-4:2024 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for self-testing
sklademVydáno: 2024-06-12
BS EN ISO 18113-4:2024 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for self-testing

BS EN ISO 18113-4:2024

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

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Označení normy:BS EN ISO 18113-4:2024
Počet stran:26
Vydáno:2024-06-12
ISBN:978 0 539 13481 0
Status:Standard
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BS EN ISO 18113-4:2024


This standard BS EN ISO 18113-4:2024 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) reagents, calibrators, and controls intended for self-testing. 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 professional use.
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