Tag: BS EN 980 CD Rom

New BS EN ISO 15223-1 CD Rom replaces obsolete BS EN 980 CD, Symbols For Use In The Labeling Of Medical Devices

For those of you in the medical device field, the BS EN 980 CD Rom, “Symbols For Use In The Labelling Of Medical Devices,” was an easy to use repository of symbols required for the export of your product to Europe.  So when the BS EN 980 was replaced by the BS EN ISO 15223-1, there was a noticeable gap in functionality.  But now Document Center Inc. is pleased to announce that we have the new BS EN ISO 15223-1 CD Rom available – “Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements.”  This is the product for you to use for the art required for your labels!

This CD not only 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 (ISO 15223-1:2012)” but also the 2011 edition of BS EN 15986 “Symbols for use in the labelling of medical devices — Requirements for labelling of medical devices containing phthalates.”

You’ll get 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 is 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) together with the symbols, the CD-ROM makes labeling easy.

The new CD can be ordered from Document Center Inc. on our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We are here to make it easier for you to use and understand the standards so important in your business.

EN 980, Symbols for use in the labelling of medical devices, available in CD Rom format

The EN 980 (BS-EN-980 – Official English language edition) is the go-to document for Symbols for use in the labeling of medical devices for use in Europe.  However, the user of this important standard often wants to integrate the symbols themselves into the various labels and other information affiliated with the sale and use of these products.

This is where the CD Rom edition sold by Document Center Inc. comes in handy.  All the symbols in the EN-980 are readily available to use in manufacturer-supplied information.

The EN 980 European Standard was prepared to provide a single methodology for the presentation of information required by all of the European Directives on medical devices.

It highlights the legislative preference within the European Union for the use of symbols in medical device labelling, thereby reducing the need for multiple translations of words into national languages.  In addition, it was intended to simplify labelling wherever possible and to prevent separate development of different symbols to convey the same information.

View this page full sizeThe meaning of some of these symbols is self-evident. Some are already in widespread use and familiar to healthcare professionals. The meaning of others will become clear with use or when viewed in the context of the device itself. Symbols used with medical devices for use by other than healthcare professionals can require additional explanations.

In this respect, attention is drawn to the fact that risk management, e.g. the use of EN ISO 14971, is an integral element in medical device design and manufacturing. The use of appropriate symbols can, therefore, be an important element in risk reduction, which is a key part of risk management and is also specifically referred to in the relevant medical device directives. Symbols should only be used without explanation when risk assessment by the manufacturer indicates that it is appropriate.

The symbols in Clause 5 of this European Standard have been in general use for some time and users have some degree of familiarity with them. Additional symbols are now being introduced in Clause 6 which may be new or unfamiliar to users. As a precaution, Clause 6 requires that the meaning of these new symbols be explained in the information supplied by the manufacturer. This is without prejudice to the harmonization of this European Standard and the symbols in it.

It is not always possible to develop symbols for all information presented with the device. Not all symbols are appropriate for all types of medical devices. The validity of information conveyed by a symbol can be adversely affected by subsequent events e.g. damage to a package can affect the sterility of a device.

BS EN 980 includes examples of how some of the symbols can be used. These are illustrative only and do not represent the only ways in which the requirements of this standard can be met.

BS EN 980 also provides information about the use of the general prohibition symbol.

All EN documents are available for sale in the official English language editions from Document Center Inc. at our website, www.document-center.com, and by phone (650-591-7600), fax (650-591-7617) and email (info@document-center.com).  And if you have any additional questions, please ask us!