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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing

ISO 18113-5:2009

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing

This international standard specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments 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: ISO181135E

Order Code Print: print not available

Edition: First

Pages: 8

ISO 18113-5:2009 Additional Details

The document also applies to apparatus and equipment intended to be used with IVD instruments for self-testing

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