Committee Draft
ISO/CD 15223-2
Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
Reference number
ISO/CD 15223-2
Edition 2
© ISO 2024
Committee Draft
Under development
A draft is being reviewed by the committee.
Will replace ISO 15223-2:2010

Abstract

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.

General information

  • Status
     : Under development
    Stage
    : Committee draft (CD) registered [30.00]
  • Edition
     : 2
  • Technical Committee :
    ISO/TC 210
  • RSS updates

Life cycle

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