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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 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

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 15223-2:2010PublishedMedical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validationInternational Standard · Published 15 Jan 2010 · ISO/TC 210