1、May 2011 Translation by DIN-Sprachendienst.English price group 12No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 01
2、.080.20; 11.040.01; 11.120.01!$pk“1777290www.din.deDDIN EN 15986Symbol for use in the labelling of medical devices Requirements for labelling of medical devices containing phthalatesEnglish translation of DIN EN 15986:2011-05Symbol zur Kennzeichnung von Medizinprodukten Anforderungen zur Kennzeichnu
3、ng von phthalathaltigen MedizinproduktenEnglische bersetzung von DIN EN 15986:2011-05Symbole utiliser pour ltiquetage des dispositifs mdicaux Exigences relatives ltiquetage des dispositifs mdicaux contenant des phthalatesTraduction anglaise de DIN EN 15986:2011-05www.beuth.deDocument comprises pages
4、In case of doubt, the German-language original shall be considered authoritative.1405.11 DIN EN 15986:2011-05 A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee CEN/CENELEC/TC 3 “Quality management and corresponding general aspects for med
5、ical devices” (Secretariat: NEN, Netherlands). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-01-13 AA Qualittsmanagement und entsprechende allgemeine Aspekte fr Medizinprodukte. The DIN Standard corresp
6、onding to the International Standard referred to in this document is as follows: ISO 7000 DIN ISO 7000 DIN EN 15986:2011-05 includes a CD-ROM containing the symbol specified in the standard, together with examples of its application, in TIFF format. National Annex NA (informative) Bibliography DIN I
7、SO 7000, Graphical symbols for use on equipment Index and synopsis 2 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 15986 March 2011 ICS 01.080.20; 11.040.01; 11.120.01 English version Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing
8、 phthalates Symbole utiliser pour ltiquetage des dispositifs mdicaux - Exigences relatives ltiquetage des dispositifs mdicaux contenant des phtalates Symbol zur Kennzeichnung von Medizinprodukten - Anforderungen zur Kennzeichnung von phthalathaltigen Medizinprodukten This European Standard was appro
9、ved 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 national standard without any alteration. Up-to-date lists and bibliographical references concerning s
10、uch 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, French, German). A version in any other language made by translation under the responsibility of a CEN and C
11、ENELEC 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 national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denma
12、rk, 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. CEN Management Centre: CENELEC Central Secretariat:Avenue Marnix 1
13、7, 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. Ref. No. EN 15986:2011 EEN 15986:2011 (E) 2 Contents Page Foreword 31 Scope 52 Terms and definitions .53
14、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 negation symbol 10Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Di
15、rective 93/42/EEC . 11Bibliography . 12DIN EN 15986:2011-05 EN 15986:2011 (E) 3 Foreword This document (EN 15986:2011) has been prepared by Technical Committee CEN/CENELEC/TC 3 “Quality management and corresponding general aspects for medical devices”, the secretariat of which is held by NEN. This E
16、uropean 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 standards shall be withdrawn at the latest by September 2011. This document has been prepared under a mandate giv
17、en 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, see informative Annex ZA, which is an integral part of this document. Attention is drawn to the possibility that
18、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 the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to i
19、mplement this European Standard: 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, Sweden,
20、 Switzerland and the United Kingdom. DIN EN 15986:2011-05 EN 15986:2011 (E) 4 Introduction This European Standard has been prepared to give expression to the legislative preference within the European Union for the use of symbols to provide information for the safe use of medical devices, and to the
21、 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 parts of medical devices containing phthalates requiring labelling, as required by the consolidated Medical Devic
22、es 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 classified as CMR 1 DBP and BBP. NOTE 3 The relative sizes of the symbol and the particular phthalates used are not
23、 specified. NOTE 4 This symbol is derived from ISO 7000-2725 (“Contains or presence of”). DIN EN 15986:2011-05 EN 15986:2011 (E) 7 Annex A (informative) Examples of uses of the symbol given in this European Standard A.1 General NOTE These examples are illustrative only and do not represent the only
24、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 Example of the symbol for “CONTAINS OR PRESENCE OF PHTHALATE“ Figure A.2 Example of the symbol for “CONTAINS O
25、R PRESENCE OF PHTHALATE“ DIN EN 15986:2011-05 EN 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 “CONTAINS OR PRESENCE OF PHTHALATE“ Figure A.4 Example of the symbol for “CONTAINS OR PRESENCE OF P
26、HTHALATE“ 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 Example of the symbol for “CONTAINS OR PRESENCE OF PHTHALATE“ DIN EN 15986:2011-05 EN 15986:2011 (E) 9
27、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 symbol for “CONTAINS OR PRESENCE OF PHTHALATE“ DIN EN 15986:2011-05 EN 15986:2011 (E) 10 Annex
28、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 80416-3:2002, Clause 7 (for the negation symbol, a large X placed over the symbol). Althoug
29、h 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. DIN EN 15986:2011-05 EN 15986:2011 (E) 11 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Dire
30、ctive 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 the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited
31、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 confers, within the limits of the scope of this standard, a presumption of conformity with
32、 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 Requirements (ERs) of the Directive 93/42/EEC Qualifying remarks This standard 7.5 W
33、ithin 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. DIN EN 15986:2011-05 EN 15986:2011 (E) 12 Bibliography 1 93/42/EEC, Council Directive on the approximation of the laws of
34、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 administrative provisions relating to the classification, packaging and labelling of dange
35、rous 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 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EE
36、A 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 used with medical device labels, labelling and information to be supplied Part 1
37、: 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, Symbols 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 DIN EN 15986:2011-05
