ISO 15223-1:2016
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements

Standard No.

ISO 15223-1:2016

Release Date

2016

Published By

International Organization for Standardization (ISO)

Status

Be replaced

Replace By

ISO 15223-1:2021

Latest

ISO 15223-1:2021

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*， 2023-12-23 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

ISO 15223-1:2016 history

• 2021 ISO 15223-1:2021 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
• 2016 ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
• 2012 ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
• 2008 ISO 15223-1:2007/Amd 1:2008 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements; Amendment 1
• 2007 ISO 15223-1:2007 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements