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.
Date of Publication: December 1, 2009
Order Code PDF: ISO181131E
Order Code Print: print not available
ISO 18113-1:2009 Additional Details
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Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems