Reference number
ISO/WD 15223-2
© ISO 2024
Working draft
ISO/WD 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
Edition 2
Deleted
Deleted
A working group has prepared a draft.
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
     : Deleted
    Stage
    : Project deleted [20.98]
  • Edition
     : 2
  • Technical Committee :
    ISO/TC 210
  • RSS updates

Life cycle

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