DIN Updates Standard on Medical Device Labeling
August 29, 2008 // Published as a news service by IHS
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The Deutsches Institut für Normung e. V. (DIN) published a revised edition of standard DIN EN 980, Symbols for use in the labeling of medical devices.
This standard was developed to harmonize the presentation of information required by all European directives on medical devices, and reflects the legislative preference within the European Union (EU) for the use of symbols in medical device labeling, thereby reducing the need for multiple translations of texts into national languages.
The standard is also intended to simplify labeling wherever possible and to prevent the development of different symbols to convey the same information.
The meaning of some of these symbols is self-evident, while that of others only becomes clear with use or when viewed in the context of the device itself. Symbols used with medical devices for use by other than health care professionals can require additional explanation.
Risk management, such as the application of standard EN ISO 14971, is an integral element in medical device design and manufacturing. The use of appropriate symbols plays an essential role in risk reduction, which is required by the relevant EU directives on medical devices. Symbols should only be used without a text explanation if risk assessment, as carried out by the manufacturer, shows this is appropriate.
In addition to symbols that have been in general use for some time, the August 2008 update of this standard introduces symbols that may be new or unfamiliar to users. The standard requires that the meaning of new symbols be explained in the information supplied by the manufacturer.
The revised standard also answers such questions as how to differentiate between the series number and the order number of a medical device, and which symbol indicates shelf life.
Source: Deutsches Institut für Normung e.V.