ISO 18113-5:2009
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing

Standard No.
ISO 18113-5:2009
Release Date
2009
Published By
International Organization for Standardization (ISO)
Status
Replace By
ISO 18113-5:2022
Latest
ISO 18113-5:2022

ISO 18113-5:2009 Referenced Document

  • EN 980 Graphical Symbols for Use in the Labelling of Medical Devices
  • IEC 61010-1 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements*2017-01-01 Update
  • IEC 61326-2-6 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment*2020-10-28 Update
  • IEC 62366 Medical devices - Application of usability engineering to medical devices*2014-01-01 Update
  • ISO 14971 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements*2019-12-10 Update
  • ISO 15223-1 Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements — Amendment 1
  • ISO 18113-1 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements*2022-10-06 Update

ISO 18113-5:2009 history

  • 2022 ISO 18113-5:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
  • 2009 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



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