ISO 18113-5:2009

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing

Digital Document2009 edition2009Purchase Options

Referenced standards

EN 980IEC 61010-1IEC 61010-2-101IEC 61326-2-6IEC 62366ISO 14971ISO 15223-1ISO 18113-1
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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing

ISO 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing.

ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.

ISO 18113-5:2009 can also be applied to accessories.

Edition2009
Standard Part No5
Published Date2009
Published ByInternational Standardization Organisation
Page Count8