NF EN ISO 15223-1

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.

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Main informations

Collections

National standards and national normative documents

Publication date

August 2012

Number of pages

36 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

1 - 09/08/2012

International kinship

ISO 15223-1:2012

European kinship

EN ISO 15223-1:2012
Sumary
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.

Replaced standards (1)
NF EN 980
July 2008
Standard Cancelled
Symbols for use in the labelling of medical devices

Le présent document spécifie les symboles graphiques destinés à être utilisés parmi les informations fournies par le fabricant avec les dispositifs médicaux. Il vient à l'appui des exigences essentielles des Directives 93/42/CEE, 90/385/CEE et 98/79/CE.

Standard replaced by (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

<p>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.</p> <p>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.</p> <p>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.</p>

Table of contents
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  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Exigences générales
    2
  • 4.1 Proposition de symboles pour adoption
    2
  • 4.2 Exigences relatives à l'utilisation
    2
  • 4.3 Autres symboles
    3
  • 5 Symboles
    3
  • 5.1 Fabrication
    4
  • 5.2 Stérilité
    7
  • 5.3 Stockage
    10
  • 5.4 Utilisation sécurisée
    12
  • 5.5 Spécifique au diagnostic in vitro
    13
  • 5.6 Transfusion/perfusion
    15
  • 5.7 Autres
    17
  • Annexe A (informative) Exemples
    18
  • Annexe B (informative) Utilisation du symbole général d'interdiction et du symbole de négation
    22
  • Bibliographie
    23
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