Overview

Specifies the symbols used to convey information supplied with medical devices, on the device, its packaging or accompanying documentation. The fourth edition (2021) is amended by Amendment 1:2025.

ISO 15223-1:2021 specifies symbols to be used with information to be supplied by the manufacturer of a medical device. It is the fourth edition and it cancels and replaces ISO 15223-1:2016. The standard is globally adopted and applies to symbols used across a wide range of medical devices — on the device itself, on its packaging, and within the accompanying information such as instructions for use.

Why symbols matter. Manufacturers and others in the supply chain must provide specific information with a medical device: manufacturer identity, batch or serial number, date of manufacture, use-by date, sterilization method, single-use status, storage conditions and much more. Providing that information as text means translating it into every language of every market the device reaches, on packaging that often has very little surface area. Standardized symbols with defined meanings solve that problem, and regulators in most major markets accept or require them. ISO 15223-1 is the reference that defines what each symbol means and the conditions of its use.

Changes in the 2021 edition. The fourth edition added 20 symbols validated in accordance with ISO 15223-2, together with five symbols previously published in ISO 7000, ISO 7001 and IEC 60417, bringing them into the medical device set. This expansion reflected regulatory developments including the information requirements introduced by the EU Medical Device Regulation and In Vitro Diagnostic Regulation.

Amendment 1:2025. An amendment published in 2025 added a defined term for authorized representative and modified the EC REP symbol so that it is no longer country- or region-specific. This is a practical change for manufacturers placing devices on multiple markets, each of which may require a local authorized representative; a region-neutral symbol avoids maintaining separate label artwork per jurisdiction.

Part 2 and symbol development. ISO 15223-2 covers symbol development, selection and validation — the methodology by which a proposed symbol is tested for comprehension before it enters Part 1. This matters because an unvalidated symbol that users misread is worse than plain text. A revision of ISO 15223-2 has been in development.

Related standards. ISO 20417 specifies what information the manufacturer must supply with a medical device; ISO 15223-1 specifies how much of it may be expressed symbolically. ISO 13485 is the certifiable quality management system standard for medical devices, under which labelling control is a documented process, and ISO 14971 covers risk management, including risks arising from information for safety.

Certification. ISO 15223-1 is a product-information requirements standard; there is no organizational certification against it. Conformity is demonstrated as part of the device's technical documentation and assessed during regulatory conformity assessment and during ISO 13485 audits of labelling controls.

Purpose

To define the symbols that may be used to convey information supplied by the manufacturer with a medical device, so that essential information can be communicated consistently and without dependence on language.

Key Benefits

• Language-independent communication of essential device information
• Reduces label translation burden across multiple markets
• Widely accepted by regulators including under EU MDR and IVDR
• Symbols validated for comprehension under the ISO 15223-2 methodology
• 2025 amendment provides a region-neutral authorized representative symbol
• Supports consistent labelling control within an ISO 13485 quality system

Key Requirements

• Use only symbols defined in the standard for the information they represent
• Apply each symbol in accordance with its defined meaning and conditions of use
• Ensure symbols are legible, durable and appropriately sized on device and packaging
• Explain symbols used in the accompanying information where required
• Apply the authorized representative symbol in line with Amendment 1:2025
• Ensure symbolic information is consistent with the information required by ISO 20417
• Control labelling artwork and revisions within the quality management system
• Reassess symbol usage when regulatory requirements or markets change

Who Needs This Standard?

Medical device manufacturers and their labelling and artwork teams, regulatory affairs professionals, in vitro diagnostic manufacturers, contract packagers and distributors of medical devices, notified bodies and auditors reviewing device labelling.

Related Standards