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ISO 15223-2:2010

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Zusammenfassung

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.

Produktspezifikationen

  • Standard von ISO
  • Ausgabedatum:
  • Edition: 1
  • Dokumenttyp: IS
  • Seiten
  • Herausgeber: ISO
  • Lieferant: ISO
  • ICS: 01.080.20
  • ICS: 11.040.01
  • Internationales Komitee: ISO/TC 210

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