DIN EN ISO 18113-1:2013 PDF

Scope: This part of ISO 18113 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. This part of ISO 18113 does not address language requirements, since that is the domain of national laws and regulations. This part of ISO 18113 does not apply to a)IVD devices for performance evaluation (e.g., for investigational use only), b)instrument marking, c)material safety data sheets.

DIN EN ISO 18113-1:2013 Referenced Document

EN 980 Graphical Symbols for Use in the Labelling of Medical Devices
IEC 62366 Medical devices - Application of usability engineering to medical devices*， 2014-01-01 Update
ISO 1000 SI units and recommendations for the use of their multiples and of certain other units; Amendment 1
ISO 13485 *， 2018-05-15 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

2021 DIN EN ISO 18113-1:2021-09 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO/DIS 18113-1:2021); German and English version prEN ISO 18113-1:2021 / Note: Date of issue 2021-08-06*I...
2013 DIN EN ISO 18113-1:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2011
2010 DIN EN ISO 18113-1:2010 In vitro diagnostic medical devices Information provided by the manufacturer