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

ISO 18113-4:2009

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

This international standard specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing.

This document is available in electronic format only. 

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Publication Details

Date of Publication: December 1, 2009

Order Code PDF: ISO181134E

Order Code Print: print not available

Edition: First

Pages: 10

ISO 18113-4:2009 Additional Details

The document also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing.

Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems