ISO 18113-1:2009

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

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

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Referenced standards

EN 980:2008IEC 62366:2007ISO 1000:1992ISO 13485:2003ISO 14971:2007ISO 15223-1:2007
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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements

ISO 18113-1:2009 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) medical devices.

Edition2009
Standard Part No1
Published Date2009
Published ByInternational Standardization Organisation
Page Count49