EN 980:2008 - Symbols for use in the labelling of medical devices

Translating instructions into multiple languages can be time-consuming, expensive, and prone to error. When dealing with health and safety issues this can become a major concern. The European Standard (EN) EN 980:2008 specifies symbols for use in the information, supplied by manufacturers, that accompanies medical devices. This standard supports the legislative preference of the European Union for the use of symbols in medical device labelling, thereby reducing the need for multiple translations. It also simplifies labelling wherever possible and prevents separate development of different symbols to convey the same information.

The symbol for CAUTION highlights the fact that there are specific warnings or precautions associated with the device

The meaning of some of these symbols is self-evident, some are already familiar to healthcare professionals, and others are already in widespread use. The meanings of others will become clear with use or when viewed in the context.

This symbol, for 'KEEP DRY' is easily recognizable to anyone familiar with the purpose of an 'umbrella.'

The use of appropriate symbols is an important element in risk reduction, which is a key part of risk management. In fact, this relationship is 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.

?br /> This symbol, for CONSULT INSTRUCTIONS FOR USE, demonstrates that symbols are meant to support, not replace, operating instructions.

The requirements of this European Standard are not intended to apply to symbols specified in other standards. However, every effort should be made to prevent the specifying of different symbols with the same meaning. This standard does not specify the requirements for information to be supplied with medical devices, which are addressed in other European Standards. The specific focus of this standard is rather to ensure that a greater clarity in symbols associated with medical device will offer greater protection to European consumers and healthcare professionals alike.