DIN EN ISO 15223-1 2022-02 PDF

Full title and description

DIN EN ISO 15223-1:2022-02 — Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements. This document is the German (DIN/EN) adoption of ISO 15223-1:2021 and contains the standardized graphical symbols and general requirements for their use on medical devices, packaging and accompanying information.

Abstract

This standard specifies symbols to convey information supplied by the manufacturer for medical devices. It defines general requirements for symbol design, presentation and application so symbols are globally understandable across regulatory jurisdictions; symbols may be used on the device, its packaging or in supplied documentation.

General information

• Status: Current / published (national adoption of ISO 15223-1:2021).
• Publication date: DIN EN ISO edition published February 2022 (DIN publication: 2022-02); original ISO edition published July 2021.
• Publisher: Deutsches Institut für Normung (DIN) — German adoption; original standard issued by ISO (ISO/TC 210).
• ICS / categories: 01.080.20 (Graphical symbols for use on specific equipment); 11.040.01 (Medical equipment in general).
• Edition / version: DIN EN ISO 15223-1:2022-02 (adoption of ISO 15223-1:2021, Edition 4, 2021).
• Number of pages: German DIN publication shows a longer published product (commonly sold as 74 pages including national/translation material); the ISO original edition is listed as 36 pages.

Scope

Specifies graphical symbols that may be used to express information that manufacturers must or should supply with medical devices. The standard applies to symbols intended for a broad spectrum of medical devices and is intended for use on the device itself, on packaging, or in the accompanying information; it does not replace symbols specified in other standards.

Key topics and requirements

• Definition and classification of symbols appropriate for medical-device labelling and documentation.
• Design, sizing, contrast and presentation requirements to ensure legibility and reproducibility.
• Rules for combining symbols with text, numbers and supplementary information.
• Guidance on intended meaning, use context and limitations of standardized symbols.
• Annex material showing examples and national/European informative annexes (as adopted in the DIN/EN version).

These topics follow the general requirements and symbol listings given in the ISO edition.

Typical use and users

Used by medical device manufacturers, regulatory and quality teams, labelling and regulatory compliance specialists, packaging designers, clinical engineers, notified bodies and conformity assessors to standardize labelling and reduce misinterpretation of device information across markets. It is applied during product development, technical documentation, labelling reviews, and submission for regulatory approval.

Related standards

Key related documents and standards include ISO 15223-2 (symbol development, selection and validation), standards on risk management and usability (e.g., ISO 14971 and IEC 62366 series), and labelling/documentation standards such as EN ISO 20417 and other regional labelling requirements. The ISO part 2 document provides the validation process for symbols intended for inclusion in 15223-1.

Keywords

medical device symbols, labelling, graphical symbols, device information, ISO 15223-1, DIN EN ISO, labelling requirements, eIFU, packaging symbols, usability

FAQ

Q: What is this standard?

A: ISO/DIN EN ISO 15223-1 defines standardized graphical symbols and the general requirements for their use on medical devices, packaging and supplied information to convey manufacturer-supplied information clearly and consistently.

Q: What does it cover?

A: It covers the meaning, presentation, design and application rules for a set of internationally standardized symbols intended to communicate safety, handling, storage, and other device-related information without relying solely on local language text.

Q: Who typically uses it?

A: Medical device manufacturers, regulatory affairs and quality teams, label and packaging designers, clinical engineers, notified bodies and conformity assessors use the standard to ensure labelling is compliant and internationally interpretable.

Q: Is it current or superseded?

A: The ISO original edition is ISO 15223-1:2021 (published July 2021). The DIN/EN national adoption was published as DIN EN ISO 15223-1:2022-02 (February 2022) and is the current adopted edition for the German/EN publication.

Q: Is it part of a series?

A: Yes — it is part of the ISO 15223 series. Part 1 contains the symbol set and general requirements; ISO 15223-2 (2010) specifies the process for symbol development, selection and validation for inclusion in Part 1.

Q: What are the key keywords?

A: Keywords include medical device symbols, labelling, graphical symbols, information supplied by the manufacturer, ISO 15223-1, DIN EN ISO, packaging symbols, and eIFU.