Abstract
Ïã¸ÛÁùºÏ²Ê¿ª½± 15223-2:2010 specifies a process for developing, selecting and validating symbols for inclusion in Ïã¸ÛÁùºÏ²Ê¿ª½± 15223-1.
The purpose of Ïã¸ÛÁùºÏ²Ê¿ª½± 15223-2:2010 is to ensure that symbols included in Ïã¸ÛÁùºÏ²Ê¿ª½± 15223-1 are readily understood by the target group.
If the symbol validation process detailed in Ïã¸ÛÁùºÏ²Ê¿ª½± 15223-2:2010 has been complied with, then the residual risks, as defined in Ïã¸ÛÁùºÏ²Ê¿ª½± 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.
Ïã¸ÛÁùºÏ²Ê¿ª½± 15223-2:2010 is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.
General information
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Status: PublishedPublication date: 2010-01Stage: International Standard to be revised [90.92]
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Edition: 1Number of pages: 16
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Technical Committee :Ïã¸ÛÁùºÏ²Ê¿ª½±/TC 210
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Life cycle
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Previously
WithdrawnÏã¸ÛÁùºÏ²Ê¿ª½± 15223:2000
WithdrawnÏã¸ÛÁùºÏ²Ê¿ª½± 15223:2000/Amd 1:2002
WithdrawnÏã¸ÛÁùºÏ²Ê¿ª½± 15223:2000/Amd 2:2004
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Now
PublishedÏã¸ÛÁùºÏ²Ê¿ª½± 15223-2:2010
A standard is reviewed every 5 years
Stage: 90.92 (To be revised) -
Will be replaced by
Under developmentÏã¸ÛÁùºÏ²Ê¿ª½±/AWI 15223-2
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