NF EN ISO 15223-1

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.

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Main informations

Collections

National standards and national normative documents

Publication date

September 2021

Number of pages

68 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

2 - 01/08/2022

International kinship

ISO 15223-1:2021

European kinship

EN ISO 15223-1:2021
Sumary
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.

Replaced standards (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.

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences générales
  • 5 Symboles
  • Annexe A (informative) Préconisations et exemples d'utilisation de symboles , y compris de plusieurs symboles
  • 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 générales en matière de sécurité et de performances concernées du Règlement (UE) 2017/745
  • Annexe ZB (informative) Relation entre la présente Norme européenne et les exigences générales en matière de sécurité et de performances concernées du Règlement (UE) 2017/746
  • Bibliographie
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