BS EN 980:2008 Historical

BS EN 980:2008 specifies symbols for use in the information supplied by the manufacturer with medical devices. The requirements of BS EN 980:2008 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. BS EN 980:2008 does not specify the requirements for information to be supplied with medical devices,which are addressed by EN 375, EN 376, EN 591, EN 592 and EN 1041.

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

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BS EN 980:2008 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 980:2008 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 980:2008 also provides information about the use of the general prohibition symbol.

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



Cross References:
EN 375
EN 376
EN 556-1:2001
EN 591
EN 592
EN 1041
EN ISO 15225
ISO 15225:2000
ISO 8601
EN ISO 14971
ISO 14971:2007
ISO 15223-1:2007
IEC 60417-DB
IEC 60601-1
IEC 61010-1
EN 80416-1
IEC 80416-1:2001
EN 80416-2
ISO 80416-2:2001
EN 80416-3
IEC 80416-3:2002
ISO 80416-4
ISO 3864-1:2002
ISO 7000:2004
EN 12264:2005
IEC/TR 60878
93/42/EEC
90/385/EEC
98/79/EC.

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