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Standard

ISO 18113-5:2022

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Zusammenfassung

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.

Produktspezifikationen

  • Standard von ISO
  • Ausgabedatum:
  • Edition: 2
  • Dokumenttyp: IS
  • Seiten
  • Herausgeber: ISO
  • Lieferant: ISO
  • ICS: 11.100.10
  • Internationales Komitee: ISO/TC 212

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