Many countries demand that medical devices provide textual information in their local language. When different languages are incorporated on a single label or piece of paperwork, this can cause issues with translation, design, and logistics. Users of medical devices that are labelled in a variety of languages may get confused, and delay in locating the proper terminology can occur. As a result, internationally recognised symbols with well specified definitions were established to address these issues.

ISO 15223-1 applies to medical device manufacturers selling similar items in countries with varied language standards for medical device labelling. Not just the manufacturers, this standard can be used by:

  • Distributors of medical devices or other representatives of manufacturers
  • Healthcare providers
  • People responsible for post-market vigilance
  • Regulatory authorities
  • Testing organizations
  • Certification bodies
  • Organizations responsible for implementing regulations affecting medical devices, and responsible for post-market surveillance
  • Consumers or end users of medical devices
The document provides the guidelines for symbols being used in medical device labelling which convey information on the safe and effective use of medical devices, as well as a collection of symbols utilized in a wide range of medical devices worldwide. These symbols can be used on the medical device, its package, and its accompanying paperwork. For a complete list of symbols along with their details, visit here.