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BS EN 980 replaced by new release BS EN ISO 15223-1, Medical Devices. Symbols To Be Used With Medical Device Labels, Labelling And Information To Be Supplied. General Requirements

For all of you in the medical device field, the BS EN 980 (Official English language edition of EN-980) “Symbols for use in the labelling of medical devices” has been a must-have in your conformance documentation collection. Now the European standard has been withdrawn and replaced by the new 2012 issue of BS EN ISO 15223-1, “Medical Devices. Symbols To Be Used With Medical Device Labels, Labelling And Information To Be Supplied. General Requirements.” Available at Document Center Inc., the new integrated standard provides consolidated International and European requirements for symbols used in medical device labelling.

The text of ISO 15223-1:2012 was approved by CEN as a EN ISO 15223-1:2012 without any modification. Use of the standard is a means of conforming to the New Approach Directive 93/42/EEC on medical devices.

In addition to the text of ISO 15223-1, the EN adoption BS EN ISO 15223-1:2012 contains three informative Annexes. The first is Annex ZA, “Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical device.” The second is Annex ZB, “Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on active implantable medical devices.” And the third is Annex ZC, “Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices.”

Expect to see more adoptions of the ISO 15223-1:2012 across various jurisdictions during the next few months.

All these documents plus a wide variety of other standards used by the Medical Device Industry are available from Document Center Inc. at our website, www.document-center.com. Or contact us by phone at +650-591-7600, fax at +650-591-7617 or by email at info@document-center.com. You may also want to review our other audit and monitoring services for standards that are particularly helpful to organizations who are required to pass conformance audits on a regular basis.

New ISO 15223-1 2012 Edition, Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements, replaces EN 980

ISO 15223-1:2012, “Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements,” has just been released and is now available from Document Center Inc. This second edition cancels and replaces the first edition (ISO 15223-1:2007) which has been technically revised. It also incorporates the amendment ISO 15223-1:2007/Amd.1:2008.

This part of ISO 15223 constitutes a technical revision of both ISO 15223-1:2007 and EN 980:2008, combining the symbols and requirements of both standards for the first time. There has been a steady convergence of the symbol requirements in ISO 15223-1 and EN 980 over recent years, with many of the previous differences between the standards resolved. Users of EN 980, “Symbols for use in the labelling of medical devices,” will want to upgrade to EN ISO 15223-1, 2012 Edition, as the EN 980 is now withdrawn and obsolete.

ISO 15223-1 represents a significant advance in the safe and effective use of symbols to transcend language, giving manufacturers, regulators and others a single set of global symbols for use with medical devices. The standard is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements. These symbols presented may be used on the medical device itself, on its packaging or in the associated documentation.

All current ISO standards and many of the obsolete revisions are available from Document Center Inc. at our website, www.document-center.com. They are available in paper format or in the United States as pdf format as well. You may want to contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We are here to assist you with any standards-related questions or requirements.

EN 980, Symbols for use in the labelling of medical devices, available in CD Rom format

The EN 980 (BS-EN-980 – Official English language edition) is the go-to document for Symbols for use in the labeling of medical devices for use in Europe. However, the user of this important standard often wants to integrate the symbols themselves into the various labels and other information affiliated with the sale and use of these products.

This is where the CD Rom edition sold by Document Center Inc. comes in handy. All the symbols in the EN-980 are readily available to use in manufacturer-supplied information.

The EN 980 European Standard was prepared to provide a single methodology for the presentation of information required by all of the European Directives on medical devices.

It highlights 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. In addition, it was 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.

All EN documents are available for sale in the official English language editions from Document Center Inc. at our website, www.document-center.com, and by phone (650-591-7600), fax (650-591-7617) and email (info@document-center.com). And if you have any additional questions, please ask us!