Home

ISO 18113-4:2009
Subscribe to updates

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* in 2015.

*ISO standards are reviewed every five years.

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.

 

  • 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
  • No revision information available

  • No corrigenda or amendments available

Related standards

Format
  • PDF

    This format preserves the paper layout, and is watermarked

  • EPUB

    This format allows documents to be read on tablets and smartphones

  • COLOUR PDF

    Enhanced user-friendly colour PDF format

  • REDLINE

    See any updates made from previous versions at a glance

  • PAPER

    Normally A4 size documents. Shipping costs apply

Language
PDF
Paper

Swiss francs CHF 58

Add to basket

Got a question?

Check out our FAQs

Email customer services
or call us on +41 22 749 08 88
09:00 – 12:30, 14:00 – 17:00 (UTC+1).