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ISO 18113-1E In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements

ISO 18113-1:2009

ISO 18113-1E In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements

This international standard defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) medical devices.

This document is available in electronic format only. 

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Publication Details

Date of Publication: December 1, 2009

Order Code PDF: ISO181131E

Order Code Print: print not available

Edition: First

Pages: 49

ISO 18113-1:2009 Additional Details

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