Abstract

ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing.

ISO 18113-4:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing.

ISO 18113-4:2009 can also be applied to accessories, where appropriate.

ISO 18113-4:2009 applies to the labels for outer and immediate containers and to the instructions for use.


General information 

  • Status
     : Withdrawn
    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

Life cycle

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