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Abstract Preview

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.


General information

  • Status :  Published
    Publication date : 2009-12
  • Edition : 1
    Number of pages : 10
  • Technical Committee
    :
    ISO/TC 212
    Clinical laboratory testing and in vitro diagnostic test systems
  • ICS :
    11.100.10
    In vitro diagnostic test systems

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Life cycle

A standard is reviewed every 5 years



Revisions / Corrigenda

  • Now confirmed
    ISO 18113-2:2009

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