BS EN ISO 15223-1:2021+A1:2025 - Page 2

Medical devices. Symbols to be used with information to be supplied by the manufacturer.. Part 1: General requirements. Amendment 1: Addition of defined term for authorized representative and modified EC REP symbol to not be country or region specific | Status: Current

Please note this is the pdf or hard copy for the standard with the amendment only. A CD-ROM with symbols is available here.

What is BS EN ISO 15223-1:2021+A1:2025- Symbols to be used with medical device labels, labelling and information to be supplied about?

Medical devices are subject to specific language requirements to ensure the information given on the label, on packaging and in the instructions can be easily read and understood by end-users in every market. To reduce the need for extensive translations and long labels, however, precisely defined and internationally agreed symbols can be used instead. BS EN ISO 15223-1:2021+A1:2025lists these symbols.

Who is BS EN ISO 15223-1:2021+A1:2025- Symbols to be used with medical device labels, labelling and information to be supplied for?

Users of this standard will include:

• medical device manufacturers;
• healthcare professionals and institutions needing to familiarize themselves with the meaning of specific symbols;
• distributors of medical devices or other representatives of manufacturers;
• healthcare providers responsible for training, as well as those being trained; and
• healthcare regulatory authorities, testing organizations, certification bodies and other organizations responsible for implementing regulations affecting medical devices and with responsibility for post-market surveillance and vigilance.

What does BS EN ISO 15223-1:2021+A1:2025- Symbols to be used with medical device labels, labelling and information to be supplied cover?

BS EN ISO 15223-1 specifies symbols used to express information supplied for a medical device. This document is applicable to symbols used in a broad spectrum of medical devices, that are available globally and need to meet different regulatory requirements. These symbols can be used on the medical device itself, on its packaging or in the accompanying information.

NOTE: The requirements of BS EN ISO 15223-1:2021+A1:2025 are not intended to apply to symbols specified in other standards.

Why should you use BS EN ISO 15223-1:2021+A1:2025- Symbols to be used with medical device labels, labelling and information to be supplied?

• Global recognition: BS EN ISO 15223-1:2021+A1:2025 provides a universal set of symbols that are recognized worldwide, helping manufacturers portray information consistently and meet the requirements of many different markets more efficiently.
• Enhanced safety and usability: The use of recognized symbols ensures the clear, consistent and rapid communication of important information on medical devices, reducing the risk of misuse and misunderstandings, and enhancing patient safety.
• Regulatory compliance: It aligns with major international regulations like the EU MDR, EU IVDR, and US FDA CFR, simplifying market entry and regulatory approval processes globally.
• Efficient communication: Use of BS EN ISO 15223-1:2021+A1:2025overcomes language barriers, making information accessible and understandable for diverse user groups and helping communicate sometimes complex information clearly and quickly.
• Quality management integration: It aligns with BS EN ISO 13485 for quality management systems in medical device manufacturing and BS EN ISO 20417 on the information to be supplied by manufacturers. This integration ensures more straightforward compliance and greater efficiency.
• Cost and time savings: It reduces the need for multiple language labels, lowering production and translation costs and streamlining the design and packaging processes, as well as minimizing waste.
• Flexible formats: BS EN ISO 15223-1:2021+A1:2025is available as a standalone CD, as a PDF or as a combined CD and PDF, as required by users;
• Addition of defined terms for authorized representative: This amendment allows for the existing harmonized ’authorized representative’ symbol (symbol 5.1.2) to be used in other regulatory jurisdictions that use the concept of an authorized representative and require the information on the device labelling. Having one standardized symbol that can be used by any jurisdiction benefits manufacturers and users by simplifying communication and reducing the need to learn and remember multiple symbols.
• Modified EC REP symbol: This amendment removes reference to 'EC' for 'European Community' which is out of date. It also broadens the application of the 'EU REP' symbol by allowing a manufacturer to identify their ‘authorized representative’ for different countries or jurisdictions. What is used to identify the country or jurisdiction is the responsibility of the regulator in that jurisdiction.

What has changed?

BS EN ISO 15223-1:2021+A1:2025is an amendment of BS EN ISO 15223-1:2021. The changes are:

• addition of defined term for authorized representative (clause 3.20); and
• modified EC REP symbol to not be country or region specific (Item 5.1.2 in Table 1 and A.4 in Annex A).