Buy I.S. EN ISO 15223-1:2021/A1:2025

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Medical 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 specific (ISO 15223 1:2021/Amd 1:2025)

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Hardcopy , PDF

Language(s)

English

Published date

13-11-2025

Publisher

National Standards Authority of Ireland

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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirement
5 Symbols
Annex A (informative) Guidance and examples of symbol use, including multiple symbols.
Annex B (informative) Use of general prohibition symbol and negation symbol
Bibliography

This document specifies symbols used to express information supplied for a medical device.

DocumentType	Standard
Pages	74
ProductNote	The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN ISO 15223-1:2021

Standards	Relationship
EN ISO 15223-1:2021	Identical
ISO 15223-1:2021	Identical

Frequently Asked Questions

I.S. EN 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.

I.S. EN ISO 15223-1 defines symbols used to communicate information on medical device labels and accompanying information. It is an Irish standard published by National Standards Authority of Ireland (NSAI).

I.S. EN ISO 15223-1 is used by medical device manufacturers preparing globally recognisable product labels and information. It is an Irish standard published by National Standards Authority of Ireland (NSAI).

I.S. EN ISO 15223-1 is National Standards Authority of Ireland (NSAI)'s standard for symbols for medical device labels, while I.S. EN ISO 20417 covers information supplied by medical device manufacturers (Ireland). I.S. EN ISO 15223-1 defines symbols used to communicate information on medical device labels and accompanying information. I.S. EN ISO 20417 specifies general requirements for identification, labelling and information supplied with medical devices.

No — I.S. EN ISO 15223-1 is an Irish standard published by National Standards Authority of Ireland (NSAI), with its listed region as Ireland.

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I.S. EN ISO 15223-1:2021/A1:2025

Medical 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 specific (ISO 15223 1:2021/Amd 1:2025)

Table of Contents

Abstract

General Product Information

International Equivalents

Industry

Sub-Industry

What is I.S. EN ISO 15223-1 used for?

What is the scope of I.S. EN ISO 15223-1?

Who is I.S. EN ISO 15223-1 written for?

What is the difference between I.S. EN ISO 15223-1 and I.S. EN ISO 20417?

Is I.S. EN ISO 15223-1 an Australian standard?