Reference number
ISO 15223-2:2010
© ISO 2024
International Standard
ISO 15223-2:2010
Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
Edition 1
2010-01
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Published (Edition 1, 2010)
This publication was last reviewed and confirmed in 2016. Therefore this version remains current.

ISO 15223-2:2010

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Format
CHF 96
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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
     : Published
    Publication date
     : 2010-01
    Stage
    : International Standard to be revised [90.92]
  • Edition
     : 1
    Number of pages
     : 16
  • Technical Committee :
    ISO/TC 210
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