1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 15986:2011Symbol for use in thelabelling of medical devices Requirements for labellingof medical devices containingphthalatesBS EN 15986:2011 BRITISH STANDARDNational forew
2、ordThis British Standard is the UK implementation of EN 15986:2011.The UK participation in its preparation was entrusted to TechnicalCommittee CH/210/3, General terminology and symbols for MedicalDevices.A list of organizations represented on this committee can beobtained on request to its secretary
3、.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 68260 5ICS 01.080.20; 11.040.01; 11.120.01Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Sta
4、ndard was published under the authority of theStandards Policy and Strategy Committee on 31 March 2011.Amendments issued since publicationDate Text affectedBS EN 15986:2011EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 15986 March 2011 ICS 01.080.20; 11.040.01; 11.120.01 English version Symbol
5、 for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates Symbole utiliser pour ltiquetage des dispositifs mdicaux - Exigences relatives ltiquetage des dispositifs mdicaux contenant des phtalates Symbol zur Kennzeichnung von Medizinprodukten -
6、 Anforderungen zur Kennzeichnung von phthalathaltigen Medizinprodukten This European Standard was approved by CEN on 22 January 2011. 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
7、 national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN and CENELEC member. This European Standard exists in three official versions (English, Frenc
8、h, German). A version in any other language made by translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN and CENELEC members are the national standards bodies and nat
9、ional electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, 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, Swe
10、den, Switzerland and United Kingdom. CEN Management Centre: CENELEC Central Secretariat:Avenue Marnix 17, B-1000 Brussels Avenue Marnix 17, B-1000 Brussels 2011 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Re
11、f. No. EN 15986:2011 EBS EN 15986:2011EN 15986:2011 (E) 2 Contents Page Foreword 31 Scope 52 Terms and definitions .53 Requirements for usage 54 Symbol labelling phthalates .6Annex A (informative) Examples of uses of the symbol given in this European Standard .7Annex B (informative) Use of the negat
12、ion symbol 10Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC . 11Bibliography . 12BS EN 15986:2011EN 15986:2011 (E) 3 Foreword This document (EN 15986:2011) has been prepared by Technical Committee CEN/CENELEC/TC 3 “Quality
13、management and corresponding general aspects for medical devices”, 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 September 2011, and conflicting national
14、 standards shall be withdrawn at the latest by September 2011. 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 EU Directive 93/42/EEC. For relationship with EU Directive 93/42/EEC,
15、 see informative Annex ZA, which is an integral part of this document. 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. According to th
16、e CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia
17、, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. BS EN 15986:2011EN 15986:2011 (E) 4 Introduction This European Standard has been prepared to give expression to the legislative preference within the
18、 European Union for the use of symbols to provide information for the safe use of medical devices, and to the legislative requirement for labelling to show the presence of certain phthalates in medical devices. This European Standard contains requirements for the labelling of medical devices or part
19、s of medical devices containing phthalates requiring labelling, as required by the consolidated Medical Devices Directive 93/42/EEC, as amended by Directive 2007/47/EC. Labelling of medical devices or parts of medical devices containing particular phthalates is required because some have been classi
20、fied as CMR 1 DBP and BBP. NOTE 3 The relative sizes of the symbol and the particular phthalates used are not specified. NOTE 4 This symbol is derived from ISO 7000-2725 (“Contains or presence of”). BS EN 15986:2011EN 15986:2011 (E) 7 Annex A (informative) Examples of uses of the symbol given in thi
21、s European Standard A.1 General NOTE These examples are illustrative only and do not represent the only ways in which the requirements of this European Standard can be met. A.2 Examples of use of the symbol for contains or presence of phthalate“: bis (2-ethylhexyl) phthalate (DEHP) Figure A.1 Exampl
22、e of the symbol for “CONTAINS OR PRESENCE OF PHTHALATE“ Figure A.2 Example of the symbol for “CONTAINS OR PRESENCE OF PHTHALATE“ BS EN 15986:2011EN 15986:2011 (E) 8 A.3 Examples of use of the symbol for contains or presence of phthalate“: dibutyl phthalate (DBP) Figure A.3 Example of the symbol for
23、“CONTAINS OR PRESENCE OF PHTHALATE“ Figure A.4 Example of the symbol for “CONTAINS OR PRESENCE OF PHTHALATE“ A.4 Examples of use of the symbol for contains or presence of phthalate“: benzyl butyl phthalate (BBP) Figure A.5 Example of the symbol for “CONTAINS OR PRESENCE OF PHTHALATE“ Figure A.6 Exam
24、ple of the symbol for “CONTAINS OR PRESENCE OF PHTHALATE“ BS EN 15986:2011EN 15986:2011 (E) 9 A.5 Examples of use of symbol for contains or presence of phthalate“: combination of bis (2-ethylhexyl) phthalate (DEHP); benzyl butyl phthalate (BBP) and dibutyl phthalate (DBP) Figure A.7 Example of the s
25、ymbol for “CONTAINS OR PRESENCE OF PHTHALATE“ BS EN 15986:2011EN 15986:2011 (E) 10 Annex B (informative) Use of the negation symbol Manufacturers wishing to communicate the meaning “does not” or “is not” where a symbol expressing this meaning does not exist, should follow the method set out in EN 80
26、416-3:2002, Clause 7 (for the negation symbol, a large X placed over the symbol). Although it is not generally recommended to use this symbology with the symbol given in this European Standard, the use of the negation symbol is permitted. BS EN 15986:2011EN 15986:2011 (E) 11 Annex ZA (informative) R
27、elationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of t
28、he New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confer
29、s, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC Clause(s)/subclauses of this EN Essential
30、Requirements (ERs) of the Directive 93/42/EEC Qualifying remarks This standard 7.5 Within the limits of the scope of this standard. WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN 15986:2011EN 15986:2011 (E) 12 B
31、ibliography 1 93/42/EEC, Council Directive on the approximation of the laws of the Member States relating to medical devices. Council of European Communities (OJ No L 169, 12.7.1993, p.1-43), as amended in 2007 2 67/548/EEC, Council Directive on the approximation of laws, regulations and administrat
32、ive provisions relating to the classification, packaging and labelling of dangerous substances 3 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/
33、548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance) 4 ISO 7000, Graphical symbols for use on equipment Index and synopsis 5 EN 12264:2005, Health informatics Categorial structures for systems of concepts 6 prEN ISO 15223-1:2009, Medical devices Symbols to be u
34、sed with medical device labels, labelling and information to be supplied Part 1: General requirements (ISO/DIS 15223-1:2009) 7 EN 80416-3:2002, Basic principles for graphical symbols for use on equipment Part 3: Guidelines for the application of graphical symbols (IEC 80416-3:2002) 8 EN 980:2008, Sy
35、mbols for use in the labelling of medical devices 9 ISO 15223-1:2007, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements 10 EN 1041, Information supplied by the manufacturer of medical devices This page deliberately le
36、ft blankBSI is the independent national body responsible for preparing British Standardsand other standards-related publications, information and services. It presents the UK view on standards in Europe and at the international level. It is incorporated by Royal Charter.British Standards Institution
37、 (BSI)raising standards worldwideBSI Group Headquarters389 Chiswick High Road London W4 4AL UKTel +44 (0)20 8996 9001Fax +44 (0)20 8996 Standards are updated by amendment or revision. Users of British Stan-dards should make sure that they possess the latest amendments or editions.It is the constant
38、 aim of BSI to improve the quality of our products and serv-ices. We would be grateful if anyone finding an inaccuracy or ambiguity whileusing this British Standard would inform the Secretary of the technical com-mittee responsible, the identity of which can be found on the inside frontcover.Tel: +4
39、4 (0)20 8996 9001 Fax: +44 (0)20 8996 7001BSI offers Members an individual updating service called PLUS which ensuresthat subscribers automatically receive the latest editions of standards.Tel: +44 (0)20 8996 7669 Fax: +44 (0)20 8996 7001Email: Buying standardsYou may buy PDF and hard copy versions
40、of standards directly using acredit card from the BSI Shop on the website addition all orders for BSI, international and foreign standards publicationscan be addressed to BSI Customer Services.Tel: +44 (0)20 8996 9001 Fax: +44 (0)20 8996 7001Email: In response to orders for international standards,
41、 it is BSI policy tosupply the BSI implementation of those that have been publishedas British Standards, unless otherwise requested.Information on standardsBSI provides a wide range of information on national, Europeanand international standards through its Knowledge Centre.Tel: +44 (0)20 8996 7004
42、Fax: +44 (0)20 8996 7005Email: Various BSI electronic information services are also available whichgive details on all its products and services. Tel: +44 (0)20 8996 7111 Fax: +44 (0)20 8996 7048Email: BSI Subscribing Members are kept up to date with standardsdevelopments and receive substantial dis
43、counts on the purchase priceof standards. For details of these and other benefits contact Membership Ad-ministration. Tel: +44 (0)20 8996 7002 Fax: +44 (0)20 8996 7001 Email: Information regarding online access to British Standards via BritishStandards Online can be found at information about BSI
44、is available on the BSI website at www.bsi- subsists in all BSI publications. BSI also holds the copyright,in the UK, of the publications of the international standardization bodies. Ex-cept as permitted under the Copyright, Designs and Patents Act 1988 no ex-tract may be reproduced, stored in a ret
45、rieval system or transmitted in anyform or by any means electronic, photocopying, recording or otherwise without prior written permission from BSI. This does not preclude the freeuse, in the course of implementing the standard of necessary details such assymbols, and size, type or grade designations. If these details are to be usedfor any other purpose than implementation then the prior written permissionof BSI must be obtained. Details and advice can be obtained from the Copy-right & Licensing Manager.Tel: +44 (0)20 8996 7070Email:
