ISO-15223-1 › Historical Revision Information
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
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ISO 15223-1:2011 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of ISO 15223-1:2011.
ISO 15223-1:2011 is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.
These symbols may be used on the medical device itself, on its packaging or in the associated documentation. The requirements of ISO 15223-1:2011 are not intended to apply to symbols specified in other standards.
Notes
Claudia's Notes:
This part of ISO 15223 constitutes a technical revision of both ISO 15223-1:2007 and EN 980:2008, combining the symbols and requirements of both standards for the first time. There has been a steady convergence of the symbol requirements in ISO 15223-1 and EN 980 over recent years, with many of the previous differences between the standards resolved. Users of EN 980, “Symbols for use in the labelling of medical devices,” will want to upgrade to EN ISO 15223-1, 2012 Edition, as the EN 980 is now withdrawn and obsolete.
To find similar documents by classification:
11.040.01 (Medical equipment in general)
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Document Number
ISO 15223-1:2012
Revision Level
2ND EDITION
Status
Superseded
Publication Date
July 1, 2012
Committee Number
ISO/TC 210