DIN EN ISO 18113-3:2013 PDF

Scope: This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for professional use. This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for professional use. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 does not apply to: a)instructions for instrument servicing or repair, b)IVD reagents, including calibrators and control materials for use in control of the reagent, c)IVD instruments for self-testing.

DIN EN ISO 18113-3:2013 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*， 2019-12-01 Update
ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements
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

2021 DIN EN ISO 18113-3:2021-09 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/DIS 18113-3:2021); German and English version prEN ISO 18113-3:2021 / Note: Date of issue 202...
2013 DIN EN ISO 18113-3:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009); German version EN ISO 18113-3:2011
2010 DIN EN ISO 18113-3:2010 In vitro diagnostic medical devices — information provided by the manufacturer