ISO 18113-4:2009
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In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 4: In vitro diagnostic reagents for self-testing

This standard was last reviewed and confirmed* in 2015.

*Therefore this version remains current


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.


  • Document published on: 2009-12-15
    Edition: 1 (Monolingual) ICS: 11.100.10
    Status: Published Stage: 90.93 (2015-08-05)
    TC/SC: ISO/TC 212 Number of Pages: 10
  • This standard has not been revised

  • No corrigenda or amendments available

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