NF EN ISO 15223-1

NF EN ISO 15223-1

January 2017
Standard Cancelled

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1 : general requirements

ISO 15223-1:2016 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this document.ISO 15223-1:2016 is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.These symbols may be used on the medical device itself, on its packaging or in the associated documentation. The requirements of this document are not intended to apply to symbols specified in other standards.

See more
View the extract
Main informations

Collections

National standards and national normative documents

Publication date

January 2017

Number of pages

41 p.

Reference

NF EN ISO 15223-1

ICS Codes

01.080.20   Graphical symbols for use on specific equipment
11.040.01   Medical equipment in general

Classification index

S99-014-1

Print number

3 - 01/04/2017

International kinship

ISO 15223-1:2016

European kinship

EN ISO 15223-1:2016
Sumary
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1 : general requirements

ISO 15223-1:2016 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this document.

ISO 15223-1:2016 is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.

These symbols may be used on the medical device itself, on its packaging or in the associated documentation. The requirements of this document are not intended to apply to symbols specified in other standards.

Replaced standards (1)
NF EN ISO 15223-1
August 2012
Standard Cancelled
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1 : general requirements

ISO 15223-1:2012 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of ISO 15223-1:2012. ISO 15223-1:2012 is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements. These symbols may be used on the medical device itself, on its packaging or in the associated documentation. The requirements of ISO 15223-1:2012 are not intended to apply to symbols specified in other standards.

Standard replaced by (1)
NF EN ISO 15223-1
September 2021
Standard Current
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1 : general requirements

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.

Table of contents
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences générales
  • 5 Symboles
  • Annexe A (informative) Exemples
  • Annexe B (informative) Utilisation du symbole général d'interdiction et du symbole de négation
  • Annexe ZA (informative) Relation entre la présente Norme européenne et les exigences essentielles de la Directive européenne 93/42/CEE [JO L 169] relative aux dispositifs médicaux
  • Annexe ZB (informative) Relation entre la présente Norme européenne et les exigences essentielles concernées de la Directive 90/385/CEE [JO L 189]
  • Annexe ZC (informative) Relation entre la présente Norme européenne et les exigences essentielles concernées de la Directive 98/79/CE [JO L 331]
  • Bibliographie
ZOOM ON ... the Requirements department
To comply with a standard, you need to quickly understand its issues in order to determine its impact on your activity.

The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.

With Requirements, quickly access the main part of the normative text!

With Requirements, quickly access the main part of the normative text!
What is the Redline format?
The Redline + service - standards comparator allows you to easily and simply identify major changes between the current standard and its last canceled version.

At a glance, you will be able to identify the additions, deletions or modifications to a text, table, figure and formula.
At a glance, you will be able to identify the additions, deletions or modifications to a text, table, figure and formula

The Redlines + service is offered to you on the collection of French standards in force, in French language and in HTML and PDF format.

For an overview of the service, click on View a standard in redline format
Need to identify, monitor and decipher standards?

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ