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Please note: BS EN ISO 15223-1:2012 supersedes BS EN 980:2008.
However, BS EN 980:2008 continues to be cited in the OJEU as a harmonized standard and is still available to purchase by contacting cservices@bsigroup.com. Please check the OJEU for further updates.
9 February 2016
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BS EN ISO 15223-1:2012 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices.
It lists symbols that satisfy the requirements of the standard and 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 15223-1:2012 are not intended to apply to symbols specified in other standards.
This latest integrated standard provides consolidated International and European requirements for symbols used in medical device labelling. Get the confidence you need to address the presentation of information considered essential by regulatory authorities for the safe and proper use of medical devices.
BS EN ISO 15223-1:2012 allows you to:
- Advance in the safe and effective use of symbols
- Grasp symbols used in a broad spectrum of medical devices
- Overcome translation issues with global markets
- Meet the requirements of regulatory authorities
- Deliver precise and defined product descriptions.
This standard is primarily intended to be used by manufacturers of medical devices who market identical products in countries where there are different language requirements for medical device labelling. It can also be of assistance to:
- Distributors of medical devices or other representatives of manufacturers;
- Healthcare providers responsible for training as well as those being trained;
- Those responsible for post-market vigilance;
- Healthcare regulatory authorities, testing organizations, certification bodies and other organizations which are responsible for implementing regulations affecting medical devices and which have responsibility for post-market surveillance;
- Consumers or end users of medical devices who draw their supplies from a number of sources and can have varied language capabilities.
The document 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.
You may also be interested in:
NEW CD-Rom - This CD Contains the 2012 edition of BS EN ISO 15223-1 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements and the 2011 edition of BS EN 15986 Symbol for use in the labelling of medical devices — Requirements for labelling of medical devices containing phthalates, together with separate graphic images of the symbols in TIF, JPEG and EPS format, which can be downloaded and reproduced easily.
The figures presented in BS EN ISO 15223-1 and BS EN 15986 are TIF files and these are the definitive versions of the drawings. All other file types have been redrawn from the definitive versions. This functionality will be particularly useful for manufacturers and suppliers of medical devices, and to manufacturers and suppliers of safety signs and stickers, and technical authors.
By including the standards (for guidance and context) and the symbols, the CD will make using the symbols – in the style and to the standards’ specification – much easier.
