SIST EN ISO 15223-1:2021 PDF

Overview

SIST EN ISO 15223-1:2021 (ISO 15223-1:2021) specifies graphical symbols for medical devices used to convey information supplied by the manufacturer. It sets general requirements for symbols that appear on the medical device itself, on packaging, or in accompanying information (instructions for use). This European adoption supersedes the 2017 edition and aligns with EU regulatory expectations (see Annex ZA mapping to Regulation (EU) 2017/745). The standard is intended for globally marketed devices that must meet different regulatory needs.

Key topics and requirements

• Standardized symbol set and use: Defines which symbols may be used to convey critical label and safety information (e.g., sterility, single-use, lot/serial number, date of manufacture/expiry, handling and storage conditions).
• Scope of application: Symbols may be applied directly to devices, packaging, or accompanying documentation; symbols specified in other standards are excluded from this document’s requirements.
• Labeling conventions: Guidance on when a symbol may be used alone versus when it must be accompanied by explanatory text in the instructions for use or other documentation.
• Regulatory alignment: Provides a voluntary means to meet certain General Safety and Performance Requirements of EU Regulation (EU) 2017/745 and supports harmonization across CEN/CENELEC member states.
• Normative references: Cross-references include ISO 15223-2 (symbol specifications), ISO 8601 (date/time formats), and ISO 3166-1 (country codes), which inform symbol application and auxiliary data formats.

Practical applications and who uses this standard

• Medical device manufacturers and labeling teams use ISO 15223-1 to select compliant symbols for product labels, packaging and instructions for use.
• Regulatory affairs professionals rely on it to demonstrate conformity with labeling requirements and to support CE marking activities under EU MDR.
• Design engineers and quality managers incorporate symbols into product artwork, packaging specifications and risk management documentation.
• Notified bodies, distributors, and procurement teams reference the standard when verifying that device information is clear, consistent and compliant.
• Useful for devices intended for global markets where concise, language-independent communication of safety and handling is essential.

Related standards

• ISO 15223-2 - Graphic symbols - Verification and validation of symbols (symbol specifications)
• ISO 8601-1 / ISO 8601-2 - Date and time formats
• ISO 3166-1 - Country codes

Using ISO 15223-1 helps ensure consistent, regulatory-aligned labelling of medical devices through recognized medical device symbols, improving user understanding and aiding global market access.