Standard

SN EN ISO 18113-2:2024

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Abstract

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.

Products specifications

  • Standard from INB
  • Published:
  • Effective:
  • Document type: EN
  • Publisher: SNV
  • Distributor: SNV
  • ICS: 11.100.10
  • National Committee: INB/NK 157

Legal references

Swiss Federal Authority: SWISSMEDIC
Designated under following Swiss law: 812.213
Designated under following EU law: Regulation (EU) 2017/746

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