ISO 15223-2:2010Published

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

Dispositifs médicaux — Symboles à utiliser avec les étiquettes, l'étiquetage et les informations à fournir relatifs aux dispositifs médicaux — Partie 2: Développement, sélection et validation de symboles

A new edition is under development: ISO/DIS 15223-2.

Abstract / scope

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.

Life cycle

Replaces

ISO 15223:2000WithdrawnMedical devices — Symbols to be used with medical device labels, labelling and information to be suppliedInternational Standard · Published 13 Apr 2000 · ISO/TC 210 ISO 15223:2000/Amd 1:2002WithdrawnMedical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Amendment 1International Standard · Published 15 Aug 2002 · ISO/TC 210 ISO 15223:2000/Amd 2:2004WithdrawnMedical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Amendment 2International Standard · Published 28 Jan 2004 · ISO/TC 210

Replaced by

ISO/WD 15223-2Deleted (project abandoned)Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validationInternational Standard · ISO/TC 210 ISO/DIS 15223-2Under developmentMedical devices — Symbols to be used with information to be supplied by the manufacturer — Part 2: Symbol development, selection and validationInternational Standard · ISO/TC 210