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
Reference number
ISO 15223-2:2010
Edition 1
2010-01
International Standard
Read sample
ISO 15223-2:2010
42343
Published (Edition 1, 2010)
This standard was last reviewed and confirmed in 2016. Therefore this version remains current.

ISO 15223-2:2010

ISO 15223-2:2010
42343
Language
Format
CHF 96
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

  •  : Published
     : 2010-01
    : International Standard to be revised [90.92]
  •  : 1
     : 16
  • ISO/TC 210
  • RSS updates

Life cycle

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)