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DS/ISO 15223-2

2011 Edition, August 29, 2011

Complete Document

Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation



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Product Details:

  • Revision: 2011 Edition, August 29, 2011
  • Published Date: August 29, 2011
  • Status: Active, Most Current
  • Document Language: English
  • Published By: Dansk Standardiseringsrad (DS)
  • Page Count: 26
  • ANSI Approved: No
  • DoD Adopted: No

Description / Abstract:

This International Standard specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1. The purpose of this International Standard is to ensure that symbols included in ISO 15223-1 are readily understood by the target group. If the symbol validation process detailed in this International Standard 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. This International Standard is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.