ISO 15223-2-2010 PDF

Full title and description

St ISO 15223-2:2010 — Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation. This part specifies a systematic process for developing, selecting and validating graphical symbols intended for use on medical devices, their packaging and accompanying information so that symbols included in Part 1 are readily understood by the intended target groups.

Abstract

ISO 15223-2:2010 defines requirements and procedures for the creation, selection and validation of medical-device symbols for inclusion in ISO 15223-1. It describes user-centered validation methods and acceptance criteria, links symbol usability to residual risk considerations (referencing ISO 14971 and IEC 62366) and provides guidance to ensure symbols convey intended meaning to the target population. The standard is intended to support consistent, comprehensible symbol use across devices, packaging and documentation.

General information

• Status: Published (International Standard); listed for review/revision by ISO.
• Publication date: January 2010 (Edition 1).
• Publisher: International Organization for Standardization (ISO) — technical committee ISO/TC 210.
• ICS / categories: 01.080.20, 11.040.01.
• Edition / version: 1 (2010).
• Number of pages: 16 (ISO published version).

Scope

Specifies a process for the development, selection and validation of graphical symbols intended for use with medical device labels, labelling and information supplied by the manufacturer. The scope covers methods to establish that a symbol is understood by its target users, documentation and record-keeping for symbol validation, and how symbol validation interacts with risk management and usability-engineering activities. The standard is not restricted to regulatory symbols but applies to any symbol intended for device-related communication.

Key topics and requirements

• Principles and objectives for symbol development (clarity, cultural neutrality, scalability).
• Design and iteration processes for candidate symbols.
• Selection criteria for candidate symbols prior to validation (intended meaning, context of use, target group).
• User validation methods (sample sizes, testing procedures, performance/understanding criteria).
• Acceptance thresholds and how residual risks related to symbol misinterpretation are addressed (link to ISO 14971 risk management and IEC 62366 usability engineering).
• Documentation and record-keeping requirements for symbol development and validation activities.
• Guidance on integration of validated symbols into ISO 15223-1 and other labelling materials.

Typical use and users

Used by medical device manufacturers, regulatory affairs and compliance teams, labelling and documentation specialists, human factors/usability engineers, graphic designers who create device symbols, notified bodies and conformity assessment bodies, and standards committees responsible for symbol harmonization. It is applied during design, labelling development and when proposing new symbols for inclusion in Part 1.

Related standards

ISO 15223-1 (Symbols — Part 1: General requirements), ISO 14971 (Risk management for medical devices), IEC 62366 (Application of usability engineering to medical devices), ISO 7000 / IEC 60417 (graphical symbols databases), ISO 13485 (Quality management systems), and ISO 20417 (information supplied by the manufacturer for medical devices). These standards are commonly used together to address symbol meaning, usability and regulatory compliance.

Keywords

medical device symbols, symbol development, symbol validation, labelling, graphical symbols, usability, human factors, risk management, ISO 15223, IEC 62366, ISO 14971, labelling requirements

FAQ

Q: What is this standard?

A: ISO 15223-2:2010 is the part of the ISO 15223 series that specifies how to develop, select and validate graphical symbols used on medical devices, their packaging and supplied information.

Q: What does it cover?

A: It covers the full lifecycle of symbol creation — from design principles and selection criteria through user-validation methods and acceptance criteria — and explains how validated symbols should be documented and integrated with risk management and usability engineering.

Q: Who typically uses it?

A: Medical device manufacturers, regulatory and quality teams, labelling specialists, human factors engineers, graphic designers, and conformity assessment bodies use it when creating or justifying symbols for device labelling and documentation.

Q: Is it current or superseded?

A: The document ISO 15223-2:2010 remains a published international standard (published January 2010). ISO lists the part for periodic review and replacement activities have been initiated (work toward a revised second edition has appeared in ISO work items and committee drafts). As of February 27, 2026, the 2010 edition is still the published Part 2; stakeholders should check with ISO or their national standards body for any formal publication of a newer edition or amendments.

Q: Is it part of a series?

A: Yes — ISO 15223 is published in parts. Part 1 contains the general requirements and the list of validated symbols for use on medical devices, and Part 2 (this document) defines the development and validation process used to add symbols to Part 1.

Q: What are the key keywords?

A: medical device symbols, symbol validation, labelling, graphical symbols, usability, human factors, risk management, ISO 15223-2.