EN 980-2008用于醫(yī)療設備上的標識圖標

1、EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMICS 01.080.20; 11.120.01 EN 980MaySupersedes EN 980:2003 English versionSymbols for use in the labelling of medical devicesSymboles utilisés pour l'étiquetage des dispostifs médicauxThis European Standard was approved by C

2、EN on 18 April 2008. Symbole zur Kennzeichnung von MedizinproduktenCEN 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 bib

3、liographical references concerningsuch 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 translationunder the resp

4、onsibility 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, Cyp

5、rus, 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 andUnited Kingdom. CEN Management Centre: rue de Stassart, 3

6、6 B-1050 Brussels© 2008 CEN/CENELEC All rights of exploitation in any form and by any means reservedworldwide for CEN national Members and for CENELECMembers. CENELEC Central Secretariat:rue de Stassart, 35 B-1050 BrusselsRef. No. EN 980:2008 EBS EN 980:2008EN 980:2008 (E) ContentsForeword.4Int

7、roduction .512344.14.255.15.25.35.45.55.65.75.85.9Scope .6Normative references .6Terms and definitions .6General requirements.7Proposal of symbols for adoption .7Requirements for usage.7Symbols already in use.8General.8Symbol for "DO NOT REUSE" .8Symbol for "USE BY" .9Symbol for

8、"BATCH CODE".9Symbol for "SERIAL NUMBER".10Symbol for "DATE OF MANUFACTURE".10Symbol for "STERILE" .11Symbols for "STERILE", including the method of sterilization .11Symbol for “STERILE USING ASEPTIC PROCESSING TECHNIQUES” .125.10Symbol for "CAT

9、ALOGUE NUMBER" .135.11Symbol for "CAUTION" .135.12Symbol for "MANUFACTURER" .145.13Symbol for "AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY" .145.14Symbol for " SUFFICIENT FOR ".155.15Symbol for "FOR IVD PERFORMANCE EVALUATION ONLY" .155.

10、16Symbol for "IN VITRO DIAGNOSTIC MEDICAL DEVICE" .165.17Symbols for "TEMPERATURE LIMITS” including indication of limits of temperature.165.18Symbol for "CONSULT INSTRUCTIONS FOR USE" .185.19Symbol for "BIOLOGICAL RISKS" .185.20Symbol for “KEEP AWAY FROM SUNLIGHT”

11、.185.21Symbol for “KEEP DRY” .195.22Symbol for “DO NOT RESTERILIZE” .195.23Symbol for “NON-STERILE” .205.24Symbol for “CONTROL”.205.25Symbol for “NEGATIVE CONTROL” .215.26Symbol for “POSITIVE CONTROL”.216New symbols .21-,-,-6.16.26.36.4General.21Symbol for “CONTAINS OR PRESENCE OF NATURAL RUBBER LAT

12、EX” .22Symbol for “DO NOT USE IF PACKAGE IS DAMAGED”.22Symbol for “STERILE FLUID PATH”.22Annex A (informative) Examples of uses of symbols given in this standard .24A.1Examples of use of symbol for "USE BY".24A.2Example of use of symbol for "BATCH CODE" .24A.3Examples of use of s

13、ymbol for "SERIAL NUMBER" .24A.4Examples of use of symbol for "DATE OF MANUFACTURE" .24A.5Examples of use of symbol for "CATALOGUE NUMBER" .25A.6Example of use of symbol for "MANUFACTURER" .25A.7Example of use of symbol for “MANUFACTURER” combined with “DATE O

14、F MANUFACTURE” .25A.8Example of use of symbol for " AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY" .25A.9Examples of use of symbol for " SUFFICIENT FOR" .262BS EN 980:2008EN 980:2008 (E) A.10Example of use of symbol for "UPPER LIMIT OF TEMPERATURE" .26A.11Example

15、of use of symbol for "LOWER LIMIT OF TEMPERATURE" .26A.12Example of use of symbol for "TEMPERATURE LIMITATION".26A.13Examples of use of symbol for “STERILE FLUID PATH” .27Annex B (informative) Use of the general prohibition symbol and the negation symbol.28B.1The general prohibit

16、ion symbol .28B.2The negation symbol.28Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of the Council Directive 93/42/EEC concerning medical devices .29Annex ZB (informative) Clauses of this European Standard addressing essential require

17、ments or other provisions of the Council Directive 90/385/EEC relating to active implantable medical devices.31Annex ZC (informative) Clauses of this European Standard addressing essential requirements or other provisions of the European Parliament and the Council Directive 98/79/EC on in vitrodiagn

18、ostic medical devices .32Bibliography.34-,-,-3BS EN 980:2008EN 980:2008 (E) ForewordThis document (EN 980:2008) has been prepared by Technical Committee CEN/CLC/TC 3 "Quality managementand corresponding general aspects for medical devices" (former CEN/TC 257 “Symbols and information provid

19、ed 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 nati

20、onal 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 E

21、N 980:2003.This document has been prepared under a mandate given to CEN by the European Commission and the EuropeanFree 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

22、 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, I

23、reland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden,Switzerland and the United Kingdom.-,-,-4IntroductionBS EN 980:2008EN 980:2008 (E) This European Standard has been prepared to give expression to the legislative pre

24、ference within the European Unionfor 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 th

25、e 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 healthcareprofessionals. The meaning of others will become

26、 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

27、 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 ex

28、planation when risk assessment by themanufacturer 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

29、 unfamiliar to users. As a precaution, Clause 6 requires that the meaning of these new symbols be explained in theinformation supplied by the manufacturer. This is without prejudice to the harmonization of this European Standard andthe symbols therein.It is not always possible to develop symbols for

30、 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

31、 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.-,-,-5BS EN 980:2008EN 980:2008 (E) 1 ScopeThis European Standard speci

32、fies symbols for use in the information supplied by the manufacturer with medicaldevices. 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 samemea

33、ning. 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 The following referenced documents are indispensable for the application of this document. For dated ref

34、erences, only the edition cited applies. For undated references, the latest edition of the referenced document (including anyamendments) applies. EN 375, Information supplied by the manufacturer with in vitro diagnostic reagents for professional useEN 376, Information supplied by the manufacturer wi

35、th in vitro diagnostic reagents for self-testingEN 556-1:2001, Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" Part 1: Requirements for terminally sterilized medical devices EN 591, Instructions for use for in vitro diagnostic instruments for

36、professional useEN 592, Instructions for use for in vitro diagnostic instruments for self-testingEN 1041, Information supplied by the manufacturer with medical devices EN ISO 15225, Nomenclature Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (

37、ISO 15225: 2000) ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply. 3.1symbol used in medical device labellingobject presented on the label and/o

38、r on the device itself and/or associated documentation of a medical device,which may utilise symbolic or iconic presentation, that communicates characteristic information (see 3.4) withoutrelying on knowledge of the language of a particular nation or people by the giver or receiver of the information3.2symbolic presentationabstract pictorial or graphic representation3.3iconic presentation pictorial or graphic representation using familiar objects including alphanumeric characters3.4characteristic informationmental represen