1、BS EN ISO 15223-1:2016Medical devices Symbolsto be used with medicaldevice labels, labelling andinformation to be suppliedPart 1: General requirements (ISO15223-1:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 15223-1:2016 BRITISH STANDARDNational for
2、ewordThis British Standard is the UK implementation of EN ISO 15223-1:2016. It supersedes BS EN ISO 15223-1:2012 which iswithdrawn.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 repres
3、ented 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 2016.Published by BSI Standards Limited 2016ISBN 978 0 580
4、 90607 7 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 December 2016.Amendments/corrigenda issued since publicationDate T e x t a f
5、 f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15223-1 November 2016 ICS 01.080.20; 11.040.01 Supersedes EN ISO 15223-1:2012 English version Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
6、(ISO 15223-1:2016) Dispositifs mdicaux - Symboles utiliser avec les tiquettes, ltiquetage et les informations fournir relatifs aux dispositifs mdicaux - Partie 1: Exigences gnrales (ISO 15223-1:2016) Medizinprodukte - Bei Aufschriften von Medizinprodukten zu verwendende Symbole, Kennzeichnung und zu
7、 liefernde Informationen - Teil 1: Allgemeine Anforderungen (ISO 15223-1:2016) This European Standard was approved by CEN on 22 October 2016. CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the sta
8、tus 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 (Englis
9、h, 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
10、 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, Po
11、rtugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. R
12、ef. No. EN ISO 15223-1:2016 EBS EN ISO 15223-1:2016EN ISO 15223-1:2016 (E) 3 European foreword This document (EN ISO 15223-1:2016) has been prepared by Technical Committee ISO/TC 210 “Quality management and corresponding general aspects for medical devices” in collaboration with Technical Committee
13、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 May 2017, and confl
14、icting national standards shall be withdrawn at the latest by May 2017. 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
15、supersedes EN ISO 15223-1:2012. 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(s). For relationship with EU Directive(s), see informative Annex ZA, Annex ZB and Annex
16、 ZC, which are integral parts of this document. The following referenced documents are indispensable for the application of this document. For undated references, the latest edition of the referenced document (including any amendments) applies. For dated references, only the edition cited applies. H
17、owever, for any use of this standard “within the meaning of Annex ZA/Annex ZB/Annex ZC”, the user should always check that any referenced document has not been superseded and that its relevant contents can still be considered the generally acknowledged state-of-art. When an IEC or ISO standard is re
18、ferred to in the ISO standard text, this shall be understood as a normative reference to the corresponding EN standard, if available, and otherwise to the dated version of the ISO or IEC standard, as listed below. NOTE The way in which these referenced documents are cited in normative requirements d
19、etermines the extent (in whole or in part) to which they apply. Table 1 Correlations between normative references and dated EN and ISO standards Normative references as listed in Clause 2 of the ISO standard Equivalent dated standard EN ISO ISO 7000 ISO 7000:2014aISO 8601 ISO 8601:2004 ISO 14971 EN
20、ISO 14971:2012 ISO 14971:2007 ISO 15223-2 ISO 15223-2:2010 aAvailable only in database format from ISO or IEC. 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,
21、 BS EN ISO 15223-1:2016EN ISO 15223-1:2016 (E) 4 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, Slovaki
22、a, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 15223-1:2016 has been approved by CEN as EN ISO 15223-1:2016 without any modification. BS EN ISO 15223-1:2016EN ISO 15223-1:2016 (E) 5 Annex ZA (informative) Relationship between this European
23、Standard and the Essential Requirements of EU Directive 93/42/EEC OJ L 169 on Medical Devices This European Standard has been prepared under a Commissions standardization request M/023 concerning the development of European standards related to medical devices to provide one voluntary means of confo
24、rming to essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169. Once this standard is cited in the Official Journal of the European Union under that Directive, compliance with the normative clauses of this standard given in Table ZA.1 confers, with
25、in the limits of the scope of this standard, a presumption of conformity with the corresponding essential requirements of that Directive, and associated EFTA regulations. NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk management process needs
26、 to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This means that risks have to be reduced “as far as possible”, “to a minimum”, “to the lowest possible level”, “minimized” or “removed”, according to the wording of the corresponding essential requirement. NOTE 2 The manufacture
27、rs policy for determining acceptable risk must be in compliance with Essential Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive. NOTE 3 This Annex ZA is based on normative references according to the table of references in the European foreword, replacing the references in the core text.
28、 NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZA.1 Correspondence between this European standard and Annex I of Directive 93/42/EEC OJ L 169 Essential Requirements (ERs) of Directive 93/42/EEC Clause(s)/subclau
29、se(s) of this European Standard Qualifying remarks/Notes 8.7 5.2.7 Provided that the symbol is provided according to the general requirements indicated in the ER 13.1 of Directive 93/42/EEC and only for non-sterile products. 13.2 4.2, 4.3 Only the first sentence of this ERs is covered, provided that
30、 the symbol is provided on the label and according to the general requirements indicated in the ER 13.1 of Directive 93/42/EEC. BS EN ISO 15223-1:2016EN ISO 15223-1:2016 (E) 6 13.3 (a) 5.1.1, 5.1.2 Provided that the symbol is provided on the label and according to the general requirements indicated
31、in the ER 13.1 of Directive 93/42/EEC. 13.3 (c) 5.2.1, 5.2.2, 5.2.3, 5.2.4, 5.2.5, 5.2.9 Provided that the symbol is provided on the label and according to the general requirements indicated in the ER 13.1 of Directive 93/42/EEC. 13.3 (d) 5.1.5, 5.1.7 Provided that the symbol is provided on the labe
32、l and according to the general requirements indicated in the ER 13.1 of Directive 93/42/EEC. If a Serial number is not provided the symbol for LOT must precede the batch code. 13.3 (e) 5.1.4 Provided that the symbol is provided on the label and according to the general requirements indicated in the
33、ER 13.1 of Directive 93/42/EEC, the “use-by” date must be expressed as, at least, the year and the month. 13.3 (f) 5.4.2 Only the first sentence of this ER is covered, provided that the symbol is provided on the label and according to the general requirements indicated in the ER 13.1 of Directive 93
34、/42/EEC. 13.3 (i) 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 Provided that the symbol is provided on the label and according to the general requirements indicated in the ER 13.1 of Directive 93/42/EEC, the ER is only covered with respect to the conditions indicated by the symbols.
35、 For other conditions, other symbols or other means of indication may be needed. BS EN ISO 15223-1:2016EN ISO 15223-1:2016 (E) 7 13.3 (k) 5.2.6, 5.2.7, 5.2.8, 5.4.1, 5.4.4, 5.4.5 Provided that the symbol is provided on the label and according to the general requirements indicated in the ER 13.1 of D
36、irective 93/42/EEC, the ER is only covered with respect to the warnings indicated by the symbols. For other warnings, other symbols or other means of indication may be needed. 13.3 (l) 5.1.3 Provided that the symbol is provided on the label and according to the general requirements indicated in the
37、ER 13.1 of Directive 93/42/EEC. Active medical devices must be labelled with at least the year of manufacture unless a “use-by” date (5.1.4) is given. The date of manufacture may be included in the batch or serial number (5.1.5, 5.1.7). 13.3 (m) 5.2.2, 5.2.3, 5.2.4, 5.2.5 Provided that the symbol is
38、 provided on the label and according to the general requirements indicated in the ER 13.1 of Directive 93/42/EEC, the ER is only covered with respect to the conditions indicated by the symbols. WARNING 1 Presumption of conformity stays valid only as long as a reference to this European standard is m
39、aintained in the list published in the Official Journal of the European Union. Users of this standard should consult frequently the latest list published in the Official Journal of the European Union. WARNING 2 Other requirements and other EU Directives may be applicable to the product(s) falling wi
40、thin the scope of this standard. BS EN ISO 15223-1:2016EN ISO 15223-1:2016 (E) 8 Annex ZB (informative) Relationship between this European standard and the essential requirements of Directive 90/385/EEC OJ L 189 aimed to be covered This European standard has been prepared under a Commissions standar
41、disation request M/023 concerning the development of European standards related to medical devices to provide one voluntary means of conforming to essential requirements of Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical
42、devices OJ L 189. Once this standard is cited in the Official Journal of the European Union under that Directive, compliance with the normative 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 es
43、sential requirements of that Directive, and associated EFTA regulations. NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance with Directive 90/385/EEC as amended by 2007/47/EC. This means that risks hav
44、e to be reduced “as far as possible”, “to a minimum”, “to the lowest possible level”, “minimized” or “removed”, according to the wording of the corresponding essential requirement. NOTE 2 The manufacturers policy for determining acceptable risk must be in compliance with Essential Requirements 1, 4,
45、 5, 8, 9 and 10 of the Directive. NOTE 3 This Annex ZB is based on normative references according to the table of references in the European foreword, replacing the references in the core text. NOTE 4 When an Essential Requirement does not appear in Table ZB.1, it means that it is not addressed by t
46、his European Standard. Table ZB.1 Correspondence between this European Standard and Directive 90/385/EEC on active implantable medical devices Essential Requirements (ERs) of Directive 90/385/EEC Clause(s)/subclause(s) of this European Standard Qualifying remarks/Notes 11 5.1.5, 5.1.6, 5.1.7 ER is c
47、overed only for indication of batch code or serial number. Components are not covered”. 14.1, 1st indent 5.2.2, 5.2.3, 5.2.4, 5.2.5 Provided that the symbol is provided on the sterile pack, This ER is only covered with respect to the conditions indicated by the symbols. For other warnings, other sym
48、bols or other means of indication may be needed. 14.1, 2nd indent 5.2.1, 5.2.2, 5.2.3, 5.2.4. 5.2.5 Provided that the symbol is provided on the sterile pack. BS EN ISO 15223-1:2016EN ISO 15223-1:2016 (E) 9 14.1, 3rd indent 5.1.1 Provided that the symbol is provided on the sterile pack. 14.1, 7th ind
49、ent 5.2.1, 5.2.2, 5.2.3, 5.2.4, 5.2.5 Provided that the symbol is provided on the sterile pack. 14.1, 8th indent 5.1.3 Provided that the symbol is provided on the sterile pack. Active implantable medical devices must be labelled with at least the month and year of manufacture. 14.1, 9th indent 5.1.4 Provided that the symbol is provided on the sterile pack. 14.2, 1st indent 5.1.1, 5.1.2 Provided that the symbol is provided on the sales packaging. The Trade name of the manufacturer must not be used with this symbol. 14.2, 7th indent
