NF ISO 15223-2

NF ISO 15223-2

March 2010
Standard Current

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 2 : symbol development, selection and validation

ISO 15223-2:2010 specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1. The purpose of ISO 15223-2:2010 is to ensure that symbols included in ISO 15223-1 are readily understood by the target group. If the symbol validation process detailed in ISO 15223-2:2010 has been complied with, then the residual risks, as defined in ISO 14971 and IEC 62366, associated with the usability of a medical device symbol are presumed to be acceptable, unless there is objective evidence to the contrary. ISO 15223-2:2010 is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.

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Main informations

Collections

National standards and national normative documents

Publication date

March 2010

Number of pages

23 p.

Reference

NF ISO 15223-2

ICS Codes

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

Classification index

S99-014-2

Print number

1 - 24/02/2010

International kinship

ISO 15223-2:2010
Sumary
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 2 : symbol development, selection and validation

ISO 15223-2:2010 specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1.

The purpose of ISO 15223-2:2010 is to ensure that symbols included in ISO 15223-1 are readily understood by the target group.

If the symbol validation process detailed in ISO 15223-2:2010 has been complied with, then the residual risks, as defined in ISO 14971 and IEC 62366, associated with the usability of a medical device symbol are presumed to be acceptable, unless there is objective evidence to the contrary.

ISO 15223-2:2010 is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.

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
    2
  • 4 Principes d'identification et de mise en place de nouveaux symboles
    3
  • 4.1 Identification du besoin de symbole
    3
  • 4.2 Symboles à applications étendues
    3
  • 4.3 Symboles à utiliser sur un nombre limité de types de dispositifs
    3
  • 5 Processus de choix et de validation d'un symbole avant intégration dans l'ISO 15223-1
    4
  • 5.1 Généralités
    4
  • 5.2 Évaluation initiale
    4
  • 5.3 Deuxième évaluation
    4
  • 6 Classification des risques
    8
  • 7 Mise en place d'un concept
    8
  • 7.1 Existence d'autres symboles
    8
  • 7.2 Conception du symbole
    9
  • 8 Évaluation
    9
  • 8.1 Essais précoces sur les concepts de symbole
    9
  • 8.2 Essais de compréhension
    10
  • 8.3 Essais de mémorisation
    10
  • 8.4 Essais d'aptitude à l'emploi
    10
  • 9 Critères d'acceptation
    11
  • 9.1 Généralités
    11
  • 9.2 Symboles présentant une pertinence relative à la sécurité entre nulle et faible
    11
  • 9.3 Symboles présentant une pertinence relative à la sécurité entre modérée et élevée
    11
  • Annexe A (normative) Informations à fournir lors du processus de mise en place du symbole pour l'adoption d'un symbole dans l'ISO 15223-1
    12
  • Annexe B (normative) Proposition de symboles graphiques de l'ISO/TC 145/SC 3
    13
  • Annexe C (normative) Proposition de formulaire de symbole graphique de la IEC/SC 3C
    15
  • Bibliographie
    17
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