Standard

SN EN ISO 18113-2:2010

Withdrawn

Note: Latest version: SN EN ISO 18113-2:2024

Existing or new amendments and versions must be purchased separately.

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Abstract

ISO 18113-2:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for professional use. ISO 18113-2:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use. ISO 18113-2:2009 can also be applied to accessories. ISO 18113-2:2009 applies to the labels for outer and immediate containers and to the instructions for use.

Products specifications

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  • Withdrawn: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

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