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

Overview

BS EN 980 is the European Standard that specifies the graphical symbols for use in the information supplied by the manufacturer with medical devices.

This European Standard has been prepared to align the presentation of information required by all European Directives on medical devices.

It gives expression to 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.

It is also intended to simplify labelling wherever possible and to prevent separate development of different symbols to convey the same information.

The 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.

BS EN 980:2008 replaces BS EN 980:2003 which remains current.

A CD-ROM is also available

Contents of BS EN 980 includes:

• Scope
• Normative references
• Terms and definitions
• General requirements
• Proposal of symbols for adoption
• Requirements for usage
• Symbols already in use
• Symbols for:
  - Do not reuse
  - Use by
  - Batch code
  - Serial number
  - Date of manufacture
  - Sterile, including the method of sterilization
  - Sterile using aseptic processing techniques
  - Catalogue number
  - Caution
  - Manufacturer"
  - Authorised representative in the European Community
  - Sufficient for
  - For IVD performance evaluation only
  - IN VITRO diagnostic medical device
  - Temperature limits, including indication of limits of temperature
  - Consult instructions for use
  - Biological risks
  - Keep away from sunlight
  - Keep dry
  - Do not resterilize
  - Non-sterile
  - Control
  - Negative control
  - Positive control
• New symbols
  - Contains or presence of natural rubber latex
  - Do not use if package is damaged
  - Sterile fluid path
  - Examples of uses of symbols given in this standard
  - Examples of use of symbol for:
  - Use by
  - Batch code
  - Serial number"
  - Date of manufacture
  - Catalogue number
  - Manufacturer, combined with date of manufacture
  - Authorised representative in the European Community
  - Sufficient for
  - Upper limit of temperature
  - Lower limit of temperature
  - Temperature limitation
  - Sterile fluid path
  - Use of the general prohibition symbol and the negation symbol
  - The general prohibition symbol
  - The negation symbol
  

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