ISO 18113-3:2009

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use

Digital Document2009 edition2009Purchase Options

Referenced standards

EN 980:2008IEC 61010-1:2001IEC 61010-2-101:2002IEC 61326-2-6:2005IEC 62366:2007ISO 14971:2007ISO 15223-1:2007ISO 18113-1:2009
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ISO 18113-3:2009

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use

ISO 18113-3:2009 specifies requirements for information supplied by the manufacturer of in vitro dignostic (IVD) instruments for professional use.

ISO 18113-3:2009 also applies to apparatus and equipment intended to be used with IVD instruments for professional use.

ISO 18113-3:2009 can also be applied to accessories, where appropriate.

Edition2009
Standard Part No3
Published Date2009
Published ByInternational Standardization Organisation
Page Count9