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
-
Status: PublishedPublication date: 2010-01Stage: International Standard to be revised [90.92]
-
Edition: 1Number of pages: 16
-
Technical Committee :ISO/TC 210
- RSS updates
Life cycle
-
Previously
-
Now
-
Will be replaced by
Under developmentISO/AWI 15223-2