Reference number
ISO 15223-2:2010
© ISO 2025
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
Read sample
Published (Edition 1, 2010)
This publication was last reviewed and confirmed in 2016. Therefore this version remains current.

ISO 15223-2:2010

Language
Format
CHF 98
Convert Swiss francs (CHF) to your currency

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
  • RSS updates

Life cycle

Got a question?

Check out our Help and Support

  2. Store
  3. Store
  4. ICS
  5. 01
  6. 01.080
  7. 01.080.20
  8. ISO 15223-2:2010