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

ISO 18113-1:2009

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.

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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