BS-EN-980 › Symbols for use in the labelling of medical devices
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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.
Labelling (process);Symbols;Graphic symbols;Medical equipment;Identification methods
To find similar documents by classification:
01.080.20 (Graphical symbols for use on specific equipment Standards included in this group shall also be included in other groups and/or sub-groups according to their subject)
11.040.01 (Medical equipment in general)
11.120.01 (Pharmaceutics in general)
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BS EN 980:2008
June 30, 2008
BS EN 980:2003
BS EN ISO 15223-1:2012
BS-EN-980 has been replaced by BS-EN-ISO-15223-1 2012 Edition, but remains current.
Be sure to consider that purchase of BS-EN-ISO-15223-1 Cd Rom Edition -- It has symbols that you can cut and paste directly into your documentation.