ISO 15223-1:2021Published

Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements

Dispositifs médicaux — Symboles à utiliser avec les informations à fournir par le fabricant — Partie 1: Exigences générales

Abstract / scope

This document 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. The requirements of this document are not intended to apply to symbols specified in other standards.

Life cycle

Amendments & corrigenda

ISO 15223-1:2021/Amd 1:2025PublishedMedical 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 specificInternational Standard · Published 3 Mar 2025 · ISO/TC 210

Replaces

ISO 15223-1:2016WithdrawnMedical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirementsInternational Standard · Published 2 Nov 2016 · ISO/TC 210