BS-EN-ISO-15223-1 › Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
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Included in this current edition are the following subparts:
2016 EDITION CORRIGENDUM 1 - March 1, 2017
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Proposal of symbols for adoption
4.2 Requirements for usage
4.3 Other symbols
5.4 Safe use
Annex A Examples
Annex B Use of general prohibition symbol and negation symbol
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.
Symbols, Identification methods, Medical equipment, Graphic symbols, Labelling (process)
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This document is available in Paper format.
BS EN ISO 15223-1:2016
Dec. 31, 2016
BS EN ISO 15223-1:2012
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