ISO 18113-4:2009 Preview

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

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

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

Buy this standard

Format Language
PDF
Paper
  • CHF58

Got a question?

Check out our FAQs


Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)