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
