ISO 15223-1:2016

Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements

Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements

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Referenced standards

EN 1041:2008EN 556-1:2001IEC 60417:1973IEC 80416-1:2008IEC 80416-3:2002ISO 14971:2007ISO 15223-2:2010ISO 18113-1:2009ISO 18113-2:2009ISO 18113-3:2009ISO 18113-4:2009ISO 18113-5:2009ISO 3864-1:2011ISO 7000:2014ISO 7010:2011ISO 8601:2004
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ISO 15223-1:2016

Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements

Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements

ISO 15223-1:2016 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 this document.

ISO 15223-1:2016 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 this document are not intended to apply to symbols specified in other standards.

Edition2016
Standard Part No1
Published Date2016
Published ByInternational Standardization Organisation
Page Count25