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.

See more
View the extract
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
  • 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
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!
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