BS EN 980:2008
Symbols for medical device labelling
What is it?BS EN 980:2008 is the European standard for symbols used by medical device manufacturers. It provides guidance on meeting European Directive labelling requirements. All medical device manufacturers must use symbols to avoid mistranslation of essential information into multiple languages. BS EN 980:2008 aims to simplify labelling and ensure the consistent use of symbols across all medical devices. It also ensures that medical device manufacturers communicate clearly with customers and meet their product expectations.
How does it work?BS EN 980:2008 explains the meaning of the symbols required for medical device labelling. The standard also outlines new symbols that manufacturers or medical professionals may be unfamiliar with. The standard recognises that not all symbols are appropriate for all medical devices, and outlines how to apply each correctly and in line with the European Directive requirements: Essential Requirements of the EU Directives 93/42/EEC. BS EN 980:2008 also provides examples of how symbols can be used and the information they convey, as well as mitigating risks such as damaged packaging. Using BS EN 980 can help simplify labelling and help prevent separate development of different symbols to convey the same information. BS EN 980 is for use with the risk management standard BS EN ISO 14971, an integral element in medical device design and manufacturing. Using the appropriate symbols can be an important element in risk reduction, a key part of risk management for medical devices.
Who should buy it?- Medical device manufacturers
- Health and medical professionals
- Companies purchasing medical devices.
BS EN 980:2008 replaces BS EN 980:2003 which remains current. BS EN 980 provides information about the use of the general prohibition symbol. Also available: BS EN 980 on CD-ROM Graphical symbols for use in the labelling of medical devices CD-ROM
What does BS EN 980 cover?Contents of the standard include:
- 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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