EN ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels@ labelling and information to be supplied - Part 1: General requirements
This document specifies requirements for symbols for use in medical device labels used to convey information for the safe and effective use of medical devices. It also provides a list of symbols that meet the requirements of this document. This document applies to symbols that are applicable to a wide range of medical devices placed on the market worldwide and therefore must meet different regulatory requirements. These symbols may be used on the medical device itself, on its packaging or in the associated documents. The requirements of this document are not intended to apply to symbols specified in other standards.
EN ISO 15223-1:2016 Referenced Document
EN 1041:2008 Information supplied by the manufacturer of medical devices
EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices*， 2024-04-20 Update
IEC 60417:1973 Graphical symbols for use on equipment. Index, survey and compilation of the single sheets.
IEC 80416-1:2008 Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration
IEC 80416-3:2002 Basic principles for graphical symbols for use on equipment - Part 3: Guidelines for the application of graphical symbols
ISO 14971:2007 Medical devices - Application of risk management to medical devices
ISO 15223-2:2010 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
ISO 18113-1:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
ISO 18113-2:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
ISO 18113-3:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
ISO 18113-4:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
ISO 18113-5:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
ISO 3864-1:2011 Graphical symbols - Safety colours and safety signs - Part 1: Design principles for safety signs and safety markings
ISO 7000:2014 Graphical symbols for use on equipment - Registered symbols
ISO 7010:2011 Graphical symbols - Safety colours and safety signs - Registered safety signs
ISO 8601:2004 Data elements and interchange formats - Information interchange - Representation of dates and times
EN ISO 15223-1:2016 history
2021EN ISO 15223-1:2021 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
2016EN ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels@ labelling and information to be supplied - Part 1: General requirements
2012EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (Remains Current)