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1、BRITISH STANDARD BS EN 980:1997 Incorporating Amendments Nos. 1 and 2 Graphical symbols for use in the labelling of medical devices The European Standard EN 980:1996, including its amendments A1:1999 and A2:2001, has the status of a British Standard ICS 01.080.20; 11.040.01 NO COPYING WITHOUT BSI PE
2、RMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:43:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 980:1997 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the
3、authority of the Standards Board and comes into effect on 15 January 1997 BSI 7 February 2002 The following BSI references relate to the work on this standard: Committee reference CH/68 Draft for comment 93/500392 DC ISBN 0 580 26714 8 Committees responsible for this British Standard The preparation
4、 of this British Standard was entrusted to Technical Committee CH/68, General terminology, symbols and information provided with medical devices, upon which the following bodies were represented: Association of Anaesthetists of Great Britain and Ireland Association of British Dispensing Opticians As
5、sociation of British Health-care Industries Association of Contact Lens Manufacturers British Anaesthetic and Respiratory Equipment Manufacturers Association British Dental Trade Association British Institute of Radiology College of Radiographers Department of Health Health and Safety Executive Inst
6、itution of Physics and Engineering in Medicine and Biology Medical Sterile Products Association Ministry of Defence National Blood Authority Royal College of Surgeons of England Surgical Dressings Manufacturers Association Amendments issued since publication Amd. No.DateComments 10801April 2000 1349
7、17 February 2002Indicated by a sideline Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:43:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 980:1997 BSI 7 February 2002 i Contents Page Committees responsibleInside front cover National forewordii Foreword2 Text of EN 9803 Licensed Copy:
8、sheffieldun sheffieldun, na, Tue Nov 07 02:43:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 980:1997 ii BSI 7 February 2002 National foreword This British Standard has been prepared by Technical Committee CH/68 and is the English language version of EN 980:1996, Graphical symbols for use in th
9、e labelling of medical devices, including amendments A1:1999 and A2:2001, published by the European Committee for Standardization (CEN). Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalo
10、gue under the section entitled “International Standards Correspondence Index” or by using the “Find facility” of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their cor
11、rect application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN title page, pages 2 to 10, an inside back cover and a back cover. The BSI copyright no
12、tice displayed in this document indicates when the document was last issued. Sidelining in this document indicates the most recent changes by amendment. Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:43:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPI
13、SCHE NORM EN 980 May 1996 +A1 August 1999 +A2 August 2001 ICS 01.040.11; 01.080.20; 11.020 Descriptors: Medical equipment, labelling, information, graphic symbols, specifications English version Graphical symbols for use in the labelling of medical devices (includes amendments A1:1999 and A2:2001) S
14、ymboles graphiques utiliss pour ltiquetage des dispositifs mdicaux (inclut les amendements A1:1999 et A2:2001) Graphische Symbole zur Kennzeichnung von Medizinprodukten (enthlt nderungen A1:1999 und A2:2001) This European Standard was approved by CEN on 1996-05-01; amendment A1 was approved by CEN o
15、n 1999-08-01; amendment A2 was approved by CEN on 2001-06-16. CEN 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 refe
16、rences concerning such national standards may be obtained on application to the Central Secretariat or to any CEN 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 member i
17、nto its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden,
18、Switzerland and United Kingdom. CEN European Committee for Standardization Comite Europeen de Normalisation Europaisches Komitee fur Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1996 Copyright reserved to CEN members Ref. No. EN 980:1996 + A1:1999 + A2:2001 E Licensed Copy: sheff
19、ieldun sheffieldun, na, Tue Nov 07 02:43:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 980:1996 BSI 7 February 20022 Foreword This European Standard has been prepared by the Technical Committee CEN/TC 257, Terminology, symbols and information provided with medical devices, the secretariat of whic
20、h is held by SFS. 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 1996, and conflicting national standards shall be withdrawn at the latest by November 1996. This European Standard has be
21、en prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s) For relationship with EU Directives, see informative Annex ZA and Annex ZB, which are an integral part of this standard. According to th
22、e CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerla
23、nd and the United Kingdom. Foreword to amendment A1 This amendment EN 980:1996/A1:1999 to EN 980:1996 has been prepared by Technical Committee CEN/TC 257, Symbols and information provided with medical devices and nomenclature for regulatory data exchange, the Secretariat of which is held by SFS. Thi
24、s amendment to the European Standard EN 980:1996 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 2000, and conflicting national standards shall be withdrawn at the latest by February 2000. This amendment to the
25、 European Standard EN 980:1996 has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). According to the CEN/CENELEC Internal Regulations, the national standards organizations of the fol
26、lowing countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Foreword to amendment A2 This amendment EN 980:1998/A2:2
27、001 to the EN 980:1996 has been prepared by Technical Committee CEN/TC 257, Symbols and information provided with medical devices and nomenclature for regulatory data exchange, the Secretariat of which is held by SFS. This amendment to the European Standard EN 980:1996 shall be given the status of a
28、 national standard, either by publication of an identical text or by endorsement, at the latest by February 2002, and conflicting national standards shall be withdrawn at the latest by February 2002. This amendment to the European Standard EN 890:1996 has been prepared under a mandate given to CEN b
29、y the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgiu
30、m, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:43:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 980:1996
31、BSI 7 February 2002 3 Contents Page Foreword2 0Introduction4 1Scope4 2Normative references4 3General requirements4 4Symbols5 4.1Symbol for “DO NOT REUSE”5 4.2Symbol for “USE BY”5 4.3Symbol for “BATCH CODE”6 4.4Symbol for “SERIAL NUMBER”6 4.5Symbol for “DATE OF MANUFACTURE”6 4.6Symbol for “STERILE”7
32、4.7Symbols for “STERILE”, including the “METHOD OF STERILIZATION”7 4.8Symbol for “CATALOGUE NUMBER”8 4.9Symbol for “ATTENTION, SEE INSTRUCTIONS FOR USE”8 4.10 This symbol is for sterile medical devices processed using aspetic technique8 Annex A (informative) Examples of uses of symbols given in this
33、 standard9 Annex B (informative) Bibliography10 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of Council Directive 93/42/EEC concerning medical devices11 Annex ZB (informative) Clauses of this European Standard addressing essential req
34、uirements or other provisions of Council Directive 90/385/EEC relating to active implantable medical devices11 Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:43:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 980:1996 4 BSI 7 February 2002 0 Introduction This European Standard has been p
35、repared to reduce the need for multiple translation of words into national languages, to simplify labelling wherever possible and to prevent separate development of different symbols to convey the same information. It has been prepared to harmonize the presentation of information required by all EEC
36、 Directives on medical devices including active implantable and in vitro diagnostic medical devices (in the course of preparation). The meaning of some of these symbols is self-evident. Some are already in widespread use and familiar to health-care professionals. The meaning of others will become cl
37、ear with use or when viewed in the context of the device itself. If appropriate, the meaning of symbols should be explained in accompanying literature when provided. Symbols used with medical devices for use by other than health-care professionals can require additional explanations. It is not alway
38、s 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 devic
39、e. Annex A provides examples of how each 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. An additional informative bibliography is given in Annex B. 1 Scope This European Standard specifies graphical sy
40、mbols for use in the information supplied by the manufacturer with medical devices. NOTEThis standard does not specify the circumstances under which particular symbols are used. Guidance on this is given in prEN 1041. 2 Normative references This European Standard incorporates by dated or undated ref
41、erence, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorpo
42、rated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. EN 556, Sterilization of medical devices Requirements for medical devices to be labelled “Sterile”. EN 28601:1992, Data elements and interchange formats Information interchange Rep
43、resentation of dates and times. (ISO 8601, 1st edition 1988 and technical corrigendum 1:1991). 3 General requirements Graphical symbols used to convey the information given in 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8 and 4.9 are given in this standard. NOTE 1Other symbols may be used to convey other i
44、nformation. Where graphical symbols are not taken from a Harmonized Standard, their meaning should be described in the documentation supplied with the device. Enclosures shown in 4.1, 4.3, 4.6, 4.7.1, 4.7.2, 4.7.3 and 4.9 shall be included as part of these symbols. NOTE 2The use of similar enclosure
45、s around other symbols is not precluded. All symbols and accompanying information shall be legible when viewed under an illumination of 215 lx using normal vision, corrected if necessary, at a distance which takes into account the specifics and size of the individual medical device. NOTE 3Colours an
46、d minimum dimensions are not specified in this standard. Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:43:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 980:1996 BSI 7 February 2002 5 4 Symbols 4.1 Symbol for “DO NOT REUSE” NOTE 1This symbol is as given in ISO 7000/1051. NOTE 2Synonyms
47、 for “do not reuse” are “single use”, “use only once”. NOTE 3See Council Directive 93/42/EEC concerning medical devices, Annex I, 13.3 f). 4.2 Symbol for “USE BY” This symbol shall be accompanied by the date expressed as given in EN 28601 as four digits for the year and two digits for the month and
48、where appropriate, two digits for the day. The date shall be adjacent to the symbol. NOTE 1For example, June 1998 becomes 1998-06. NOTE 2The relative size and location of the symbol and the date are not specified. NOTE 3The symbol is intended to indicate that the device should not be used after the
49、end of the month shown or the day, if applicable. NOTE 4Synonym for “use by” is “the time limit for implanting a device safely” for active implantable medical devices only. NOTE 5See Council Directive 90/385/EEC relating to active implantable medical devices, Annex I, 14.1 and Council Directive 93/42/EEC concerning medical devices, Annex I, 13.3 e). Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:43:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 980:1996 6 BSI 7 February 2002 4.3 Symbol for “BATCH CODE” This symbol shall be accompanied by the man
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