Reference number
ISO 18113-4:2009
© ISO 2024
ISO 18113-4:2009
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
Edition 1
2009-12
Withdrawn
Withdrawn (Edition 1, 2009)

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     : Withdrawn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
    Stage
    : Withdrawal of International Standard [95.99]
  • Edition
     : 1
    Number of pages
     : 10
  • Technical Committee :
    ISO/TC 212
    ICS :
    11.100.10 
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