EN ISO 15223-1 Symbols to be used with Information to be Provided by the Manufacturer - General Requirements

EN ISO 15223-1 is a well-established international standard that communicates essential information and provides strictly defined and internationally accepted symbols for use in or on medical devices.

Who is EN ISO 15223-1 for?

• Medical Device Manufacturers
• Healthcare professionals and institutions who need to be familiar with the meanings of certain symbols
• Medical device distributors or other representatives of manufacturers
• Health care providers responsible for education and those responsible for education
• Health care regulatory authorities, testing organizations, certification bodies and other organizations responsible for enforcing regulations affecting medical devices and responsible for post-market surveillance and vigilance.

Medical device manufacturers and others in the supply chain must provide certain information necessary for the safe and correct use of the medical device. Symbols can be used to convey this information without the need to translate the text into multiple languages.

The standard provides clear, validated symbols. Its use can save significant costs and labeling space and avoid the need for costly translations or labeling changes. As symbols are recognized internationally, a single symbol should be adopted in all regions. These symbols may be used on the medical device itself, on its packaging, or on related documents.

EUROLAB assists manufacturers with EN ISO 15223-1 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.