Standard

ISO 15223-2:2010

Current

Existing or new amendments and versions must be purchased separately.

Language
Services

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.

Products specifications

  • Standard from ISO
  • Published:
  • Edition: 1
  • Document type: IS
  • Pages
  • Publisher: ISO
  • Distributor: ISO
  • ICS: 01.080.20
  • ICS: 11.040.01
  • International TC: ISO/TC 210

Product Relations

Product life cycle