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New International Standard Guides Selection of Symbols on Medical Device Labels

In today's global economy, medical devices may be designed in one country, manufactured in another, and used by doctors worldwide. Symbols that can be understood by speakers of any language are a key part of safe usage of medical devices, and a new International Standard from the International Organization for Standardization (ISO) will guide manufacturers and regulators in selecting and validating the symbols used on device labels.

ISO 15223-2:2010, Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 2: Symbol development, selection and validation, includes methods for validating those candidate symbols being proposed for inclusion in ANSI/AAMI/ISO 15223-1, Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements. ISO 15223-2 aims to improve the quality of symbols developed for use in labeling by providing guidance on symbol development and a robust test methodology that assures a symbol's suitability.

ISO 15223-2 has been developed by ISO technical committee ISO Technical Committee (TC) 210, Quality management and corresponding general aspects for medical devices. The U.S. holds the secretariat of this committee, and the American National Standards Institute has delegated leadership responsibilities to the Association for the Advancement of Medical Instrumentation (AAMI), an ANSI member and accredited standards developer. AAMI is also the ANSI-accredited U.S. Technical Advisory Group (TAG) administrator for this TC.

ANSI/AAMI/ISO 15223-1 was originally developed by ISO TC 210 in 2007 and was amended in 2008. The document has since been nationally adopted by AAMI as an American National Standard.

"The use of standardized symbols agreed by international consensus avoids the confusion that users may experience when presented with labeling in a number of different languages," said Leighton Hansel, director of regulatory affairs for Abbott Laboratories and convener of the ISO working group that developed the standard. "There was a need for systematic methodology for the development and presentation of symbols proposed for adoption in ISO 15223-1. Part 2 was developed to meet that need and includes detailed processes to reduce the probability of misinterpretation of symbols."

For more information, see the ISO press release.


Jana Zabinski

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Beth Goodbaum

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