National foreword

This British Standard is the UK implementation of EN 980:2008. It supersedes BS EN 980:2003 which will be withdrawn on 31 May 2010.

The UK participation in its preparation was entrusted by Technical Committee CH/210, Quality management and corresponding general aspects for medical devices, to Subcommittee CH/210/3, General terminology and symbols.

A list of organizations represented on this committee can be obtained on request to its secretary.

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2008

This European Standard was approved by CEN on 18 April 2008.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN or CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN and/or CENELEC member into its own language and notified to the CEN Management Centre has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees, respectively, of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

Foreword

This document (EN 980:2008) has been prepared by Technical Committee CEN/CLC/TC 3 "Quality management and corresponding general aspects for medical devices" (former CEN/TC 257 “Symbols and information provided with medical devices and nomenclature for regulatory data exchange”), the secretariat of which is held by NEN.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by November 2008, and conflicting national standards shall be withdrawn at the latest by May 2010.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN 980:2003.

This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive(s).

For relationship with EC Directive(s), see informative Annex ZA, ZB, and ZC, which are an integral part of this document.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.

Introduction

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

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 therein.

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.

Annex A provides 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.

Annex B provides information about the use of the general prohibition symbol.

1 Scope

This European Standard specifies symbols for use in the information supplied by the manufacturer with medical devices. The requirements of this European Standard 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. This standard 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.

2 Normative references

3 Terms and definitions

4 General requirements

4.1 Proposal of symbols for adoption

4.2 Requirements for usage

5 Symbols already in use

5.1 General

5.2 Symbol for "DO NOT REUSE"

5.3 Symbol for "USE BY"

5.4 Symbol for "BATCH CODE"

5.5 Symbol for "SERIAL NUMBER"

5.6 Symbol for "DATE OF MANUFACTURE"

5.7 Symbol for "STERILE"

5.8 Symbols for "STERILE", including the method of sterilization

5.9 Symbol for "STERILE USING ASEPTIC PROCESSING TECHNIQUES"

5.10 Symbol for "CATALOGUE NUMBER"

5.11 Symbol for "CAUTION"

5.12 Symbol for "MANUFACTURER"

5.13 Symbol for "AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY"

5.14 Symbol for "SUFFICIENT FOR"

5.15 Symbol for "FOR IVD PERFORMANCE EVALUATION ONLY"

5.16 Symbol for "IN VITRO DIAGNOSTIC MEDICAL DEVICE"

5.17 Symbols for "TEMPERATURE LIMITS" including indication of limits of temperature

5.18 Symbol for "CONSULT INSTRUCTIONS FOR USE"

5.19 Symbol for "BIOLOGICAL RISKS"

5.20 Symbol for “KEEP AWAY FROM SUNLIGHT”

5.21 Symbol for “KEEP DRY”

5.22 Symbol for “DO NOT RESTERILIZE”

5.23 Symbol for “NON-STERILE”

5.24 Symbol for “CONTROL”

5.25 Symbol for “NEGATIVE CONTROL”

5.26 Symbol for “POSITIVE CONTROL”

6 New symbols

6.1 General

6.2 Symbol for “CONTAINS OR PRESENCE OF NATURAL RUBBER LATEX”

6.3 Symbol for “DO NOT USE IF PACKAGE IS DAMAGED”

6.4 Symbol for “STERILE FLUID PATH”

Bibliography

BS EN 980:2008

Symbols for use in the labelling of medical devices

Published:

30 Jun 2008

Withdrawn:

1 Jan 2013