Progress on European and international standards on symbols for medical device labelling

Ballots on amendment to European adoption and new international edition of ISO 15223-1

Medical devices have to be provided accompanied by specific information that is essential for its safe and proper use. This information can be on the medical device itself, as part of the packaging, or in other accompanying information. When appropriate information can be provided as symbols. The use of recognised symbols that have a specific meaning can reduce the need for translation and the amount of information on the label. ISO 15223-1-  Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements - provides internationally-recognized symbols for the provision of this specific information.

ISO 15223-1 has been adopted in Europe as EN ISO 15223-1. An amendment is currently in preparation to EN ISO 15223-1:2016. This European amendment makes changes to the  European Foreword and European Annex Zs, which show the relationship between the European regulatory requirements and the clauses of the standard. EN ISO 15223-1 is one of the standards listed in the draft Standardization Request from the European Commission to the European Standards Organizations for standard to support the Medical Devices and In Vitro Diagnostic Medical Devices Regulations (MDR and IVDR). The main purpose of the amendment is to include additional Annex Zs for the MDR and IVDR.

In parallel, a new edition of  ISO 15223-1 is in preparation at International level. This will be the fourth edition of the standard and will replace ISO 15223-1:2016. The main changes in the new edition are:

• Addition of 20 new validated symbols
• Addition of five symbols from other standards
• Deletion of the defined term ‘labelling’
• Inclusion of additional defined terms from other standards
• Expansion of the informative annex containing examples
• Inclusion of information about European Regulations to informative notes

New symbols added during the revision process have been placed at the end of the pertinent section. This keeps the numbering of existing symbols constant to assist easy referencing in other documents.

The new symbols that have been added include:

• Medical device
• Sterilized by vapour phase hydrogen peroxide
• Sterile barrier system
• Contains a medicinal substance
• Contains biological material of animal origin
• Contains biological material of human origin
• Contains nano-sized materials
• Indication of a modification to the original packaging configuration of the medical device, e.g. repackaging of a multipack to single units
• Unique Device Identification information

The standard for symbols is important to manufacturers of medical devices and other organizations in the medical device supply chain. Understanding the meaning of symbols is also important to users of medical devices, who need to understand the information that is being provided to them. It is important to keep up to date with the progress of these key standards.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development