Buy ISO 15223-1:2021

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

Amended by

ISO 15223-1:2021/Amd 1:2025

Available format(s)

Hardcopy , PDF

Language(s)

French, English

Published date

06-07-2021

Publisher

International Organization for Standardization

€189.00

Excluding VAT

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.

Committee	ISO/TC 210
DocumentType	Standard
Pages	38
PublisherName	International Organization for Standardization
Status	Current
Supersedes	ISO 15223-1:2016

Standards	Relationship
BS EN ISO 15223-1:2021	Identical
I.S. EN ISO 15223-1:2021/A1:2025	Identical
NEN-EN-ISO 15223-1:2021	Identical
I.S. EN ISO 15223-1:2021	Identical
EN ISO 15223-1:2021	Identical
CEI UNI EN ISO 15223-1:2022-07	Identical
DS/EN ISO 15223-1:2021	Identical
BS EN ISO 15223-1:2021	Equivalent
DS/ISO 15223-1:2021	Identical
IS 18105 : Part 1 : 2023	Identical
ABNT NBR ISO 15223-1:2022	Identical
BS EN ISO 15223-1:2021	Identical
UNE-EN ISO 15223-1:2022	Identical

AAMI/ISO/ IEC Guide 63:2019	Guide to the development and inclusion of aspects of safety in International Standards for medical devices
ANSI/AAMI ST24:2024	General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities
CEI EN IEC 61010-2-101:2023	Safety requirements for electrical equipment for measurement, control, and laboratory use Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment

Frequently Asked Questions

ISO 15223-1 defines symbols used to communicate information on medical device labels and accompanying information. In practice it is applied by medical device manufacturers preparing globally recognisable product labels and information.

ISO 15223-1 defines symbols used to communicate information on medical device labels and accompanying information. It is an international standard published by International Organization for Standardization (ISO).

ISO 15223-1 is International Organization for Standardization (ISO)'s standard for symbols for medical device labels, while ISO 20417 covers information supplied by medical device manufacturers (International). ISO 15223-1 defines symbols used to communicate information on medical device labels and accompanying information. ISO 20417 specifies general requirements for identification, labelling and information supplied with medical devices.

ISO 15223-1 is used by medical device manufacturers preparing globally recognisable product labels and information. It is an international standard published by International Organization for Standardization (ISO).

ISO 15223-1 is an international standard published by International Organization for Standardization (ISO), and is applied internationally rather than in a single country.

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ISO 15223-1:2021

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

Abstract

General Product Information

International Equivalents

Standards Referenced By This Book

Industry

Sub-Industry

What is ISO 15223-1 used for?

What is ISO 15223-1?

What is the difference between ISO 15223-1 and ISO 20417?

Who needs to comply with ISO 15223-1?

Where does ISO 15223-1 apply?