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.
Status: PublishedPublication date: 2010-01
Edition: 1Number of pages: 16
Technical Committee: ISO/TC 210 Quality management and corresponding general aspects for products with a health purpose including medical devices
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|std 1 92|
|std 2 92||Paper|
ISO 15223:2000/Amd 1:2002Withdrawn
ISO 15223:2000/Amd 2:2004
A standard is reviewed every 5 years
Stage: 90.92 (To be revised)
Will be replaced byUnder development
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