BS EN ISO 15223-1-2012

raising standards worldwide™ NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BSI Standards Publication BS EN ISO 15223-1:2012 Incorporating corrigendum July 2012 Part 1: General requirements (ISO 15223-1:2012) Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS - - ` , , ` ` ` , , , , ` ` ` ` - ` - ` , , ` , , ` , ` , , ` - - - BS EN ISO 15223-1:2012 BRITISH STANDARD National fore word word文档格式规范word作业纸小票打印word模板word简历模板免费word简历 This British Standard is the UK implementation of EN ISO 15223-1:2012. It supersedes BS EN 980:2008 which will be withdrawn on 31 January 2013. The UK participation in its preparation was entrusted to Technical Committee CH/210/3, General terminology and symbols for Medical Devices. 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. © The British Standards Institution 2012. Published by BSI Standards Limited 2012 ISBN 978 0 580 80162 4 ICS 01.080.20; 11.040.01 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 31 July 2012. Amendments/Corrigenda issued since publication Date Text affected 31 July 2012 Date of withdrawal added to supersession Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS - - ` , , ` ` ` , , , , ` ` ` ` - ` - ` , , ` , , ` , ` , , ` - - - EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN ISO 15223-1 July 2012 ICS 01.080.20; 11.040.01 Supersedes EN 980:2008 English version Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012) Dispositifs médicaux - Symboles à utiliser avec les étiquettes, l'étiquetage et les informations à fournir relatifs aux dispositifs médicaux - Partie 1: Exigences générales (ISO 15223-1:2012) Medizinprodukte - Bei Aufschriften von Medizinprodukten zu verwendende Symbole, Kennzeichnung und zu liefernde Informationen - Teil 1: Allgemeine Anforderungen (ISO 15223-1:2012) This European Standard was approved by CEN on 24 May 2012. 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-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 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 national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels © 2012 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 ISO 15223-1:2012 E Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS --`,,```,,,,````-`-`,,`,,`,`,,`--- BS EN ISO 15223-1:2012 EN ISO 15223-1:2012 (E) 3 Foreword This document (EN ISO 15223-1:2012) has been prepared by Technical Committee ISO/TC 210 "Quality management and corresponding general aspects for medical devices" in collaboration with Technical Committee CEN/CLC/TC 3 “Quality 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 January 2013, and conflicting national standards shall be withdrawn at the latest by January 2013. 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 980:2008. 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 Directives. For relationship with EU Directives, see informative Annex ZA, ZB and ZC, which are integral parts 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, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 15223-1:2012 has been approved by CEN as a EN ISO 15223-1:2012 without any modification. Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS - - ` , , ` ` ` , , , , ` ` ` ` - ` - ` , , ` , , ` , ` , , ` - - - BS EN ISO 15223-1:2012 EN ISO 15223-1:2012 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices 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 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 the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on medical devices Clauses/subclauses of this European Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/notes 5.2.7 8.7 4 13.2 Only the first two sentences of this ER are covered. 5.1.1, 5.1.2 13.3 (a) 5.1.6 13.3 (b) 5.2.1, 5.2.2, 5.2.3, 5.2.4, 5.2.5, 5.2.9 13.3 (c) 5.1.5, 5.1.7 13.3 (d) 5.1.4 13.3 (e) 5.4.2 13.3 (f) Only the first sentence of this ER is covered. 5.3.1, 5.3.2, 5.3.3, 5.3.4,5.3.5, 5.3.6, 5.3.7, 5.3.8, 5.3.9 13.3 (i) 5.4.3 13.3 (j) 5.2.6, 5.2.7, 5.2.8, 5.4.1, 5.4.4, 5.4.5 13.3 (k) This ER is covered only in respect of the particular warnings or precautions that these symbols indicate. For other warnings, other symbols or other means of indication may be needed. 5.1.3 13.3 (l) 5.2.2, 5.2.3, 5.2.4, 5.2.5 13.3 (m) WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS - - ` , , ` ` ` , , , , ` ` ` ` - ` - ` , , ` , , ` , ` , , ` - - - BS EN ISO 15223-1:2012 EN ISO 15223-1:2012 (E) 5 Annex ZB (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on active implantable medical devices 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 90/385/EEC on active implantable 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 ZB.1 confers, 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 ZB.1 — Correspondence between this European Standard and Directive 90/385/EEC on active implantable medical devices Clauses/subclauses of this European Standard Essential Requirements (ERs) of Directive 90/385/EEC Qualifying remarks/notes 5.1.5, 5.1.6, 5.1.7 11 4 14 Only with regard to the use of symbols. 5.2.2, 5.2.3, 5.2.4, 5.2.5 14.1, 1st indent 5.1.6 14.1, 2nd indent 5.1.1 14.1, 3rd indent 5.1.5, 5.1.6, 5.1.7, 5.4.3, 5.4.4 14.1, 4th indent Only identifying the model and batch or serial number, and directing users to the instructions for use for further information and precautions. 5.2.1 14.1, 7th indent 5.1.3 14.1, 8th indent 5.1.4 14.1, 9th indent 5.1.1, 5.1.2 14.2, 1st indent 5.1.5, 5.1.6, 5.1.7, 5.4.3, 5.4.4 14.2, 2nd indent Only identifying the model and batch or serial number, and directing users to the instructions for use for further information and precautions. 5.2.6, 5.2.7 14.2, 4th indent 5.2.1 14.2, 7th indent 5.1.3 14.2, 8th indent 5.1.4 14.2, 9th indent 5.3.1, 5.3.2, 5.3.3, 5.3.4, 5.3.5, 5.3.6, 5.3.7, 5.3.8, 5.3.9 14.2, 10th indent Only the conditions for transporting and storing the device are addressed. 5.2.8 15, 8th indent Only the warning “do not use the product, if the product sterile barrier system or its packaging is compromised” is addressed. WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS - - ` , , ` ` ` , , , , ` ` ` ` - ` - ` , , ` , , ` , ` , , ` - - - BS EN ISO 15223-1:2012 EN ISO 15223-1:2012 (E) 6 Annex ZC (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices 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 98/79/EC on in vitro diagnostic 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 ZC.1 confers, 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 ZC.1 — Correspondence between this European Standard and Directive 98/79/EC on in vitro diagnostic medical devices Clauses/subclauses of this European Standard Essential Requirements (ERs) of Directive 98/79/EC Qualifying remarks/notes 5.4.3 B.8.1 Only the second part of the fourth paragraph is covered: “If individual full labelling of each unit is not practicable, the information must be set out on the packaging and/or in the instructions for use supplied with one or more devices”. 4 B.8.2 Only the first two sentences of this ER are covered. 5.1.1, 5.1.2 B.8.4 (a) 5.1.3, 5.1.6, 5.5.2, 5.5.3, 5.5.4, 5.5.5 B.8.4 (b) 5.2.1, 5.2.2, 5.2.3, 5.2.4, 5.2.5, 5.2.7, 5.2.9 B.8.4 (c) 5.1.5, 5.1.7 B.8.4 (d) 5.1.4 B.8.4 (e) 5.5.6 B.8.4 (f) 5.5.1 B.8.4 (g) 5.3.1, 5.3.2, 5.3.3, 5.3.4, 5.3.5, 5.3.6, 5.3.7, 5.3.8, 5.3.9 B.8.4 (h) 5.4.3 B.8.4 (i) 5.2.6 , 5.2.8, 5.4.1, 5.4.2, 5.4.4, 5.4.5 B.8.4 (j) 5.1.5, 5.1.7 B.8.6 WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS - - ` , , ` ` ` , , , , ` ` ` ` - ` - ` , , ` , , ` , ` , , ` - - - BS EN ISO 15223-1:2012 ISO 15223-1:2012(E) © ISO 2012 – All rights reserved iii Contents Page Foreword ............................................................................................................................................................ iv� Introduction ......................................................................................................................................................... v� 1� Scope ...................................................................................................................................................... 1� 2� Normative references ............................................................................................................................ 1� 3� Terms and definitions ........................................................................................................................... 1� 4� General requirements ........................................................................................................................... 2� 4.1� Proposal of symbols for adoption ....................................................................................................... 2� 4.2� Requirements for usage ....................................................................................................................... 2� 4.3� Other symbols ....................................................................................................................................... 3� 5� Symbols .................................................................................................................................................. 3� 5.1� Manufacture ........................................................................................................................................... 4� 5.2� Sterility.................................................................................................................................................... 6� 5.3� Storage ................................................................................................................................................... 9� 5.4� Safe use ................................................................................................................................................ 11� 5.5� IVD-specific .......................................................................................................................................... 12� 5.6� Transfusion/infusion ........................................................................................................................... 14� 5.7� Other ..................................................................................................................................................... 16� Annex A (informative) Examples ..................................................................................................................... 17� Annex B (informative) Use of general prohibition symbol and negation symbol ...................................... 21� Bibliography ...................................................................................................................................................... 22� Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS --`,,```,,,,````-`-`,,`,,`,`,,`--- BS EN ISO 15223-1:2012 ISO 15223-1:2012(E) iv © ISO 2012 – All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 15223-1 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices. This second edition cancels and replaces the first edition (ISO 15223-1:2007) and EN 980:2008, which have been technically revised. It also incorporates the amendment ISO 15223-1:2007/Amd.1:2008. ISO 15223 consists of the following parts, under the general title Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied: � Part 1: General requirements � Part 2: Symbol development, selection and validation NOTE Future symbols intended to appear in this part of ISO 15223 are to be validated in accordance with ISO 15223-2. Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS --`,,```,,,,````-`-`,,`,,`,`,,`--- BS EN ISO 15223-1:2012 ISO 15223-1:2012(E) © ISO 2012 – All rights reserved v Introduction This part of ISO 15223 addresses the presentation of certain items of information that are considered by regulatory authorities to be essential for the safe and proper use of medical devices. As such, the items are required to appear with the medical device in most regulatory domains. The information can be required to appear on the medical device itself, as part of the label, or provided with the medical device. Many countries require that their own language be used to display textu