1、April 2017 English price group 21No 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 01.080.20; 11.040.01!%cjH“2647137w
2、ww.din.deDIN EN ISO 15223-1Medical devices Symbols to be used with medical device labels, labelling and information tobe supplied Part 1: General requirements (ISO15223-1:2016,Correctedversion 2017-03);English version EN ISO 15223-1:2016, with CD-ROM,English translation of DIN EN ISO 15223-1:2017-04
3、Medizinprodukte Bei Aufschriften von Medizinprodukten zu verwendende Symbole, Kennzeichnung und zu liefernde Informationen Teil 1: Allgemeine Anforderungen (ISO 15223-1:2016, korrigierte Fassung 2017-03);Englische Fassung EN ISO 15223-1:2016, mit CD-ROM,Englische bersetzung von DIN EN ISO 15223-1:20
4、17-04Dispositifs mdicaux Symboles utiliser avec les tiquettes, ltiquetage et les informations fournir relatifs aux dispositifs mdicaux Partie 1: Exigences gnrales (ISO 15223-1:2016, Version corrige 2017-03);Version anglaise EN ISO 15223-1:2016, avec CD-ROM,Traduction anglaise de DIN EN ISO 15223-1:2
5、017-04SupersedesDIN EN ISO 15223-1:2013-02www.beuth.deDocument comprises 42 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.04.17 DIN EN ISO 15223-1:2017-04 2 A comma is used as the decimal marker. National foreword This docume
6、nt (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 CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical devices” (Secretariat: NEN,
7、 Netherlands). The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medical), Working Committee NA 063-01-13 AA “Quality management and corresponding general aspects for medical devices”. The DIN Standards corresponding to the International
8、 Standards referred to in this document are as follows: ISO 3864-1 DIN ISO 3864-1 ISO 7000 DIN ISO 7000 ISO 7010 DIN EN ISO 7010 ISO 8601 DIN ISO 8601 ISO 14971 DIN EN ISO 14971 ISO 18113-1 DIN EN ISO 18113-1 ISO 18113-2 DIN EN ISO 18113-2 ISO 18113-3 DIN EN ISO 18113-3 ISO 18113-4 DIN EN ISO 18113-
9、4 ISO 18113-5 DIN EN ISO 18113-5 IEC 80416-3 DIN EN 80416-3 DIN EN ISO 15223-1, based on ISO 15223-1, 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:
10、 Symbol development, selection and validation NOTE 1 Future symbols intended to appear in ISO 15223-1 are to be validated in accordance with ISO 15223-2. NOTE 2 Only ISO 15223-1:2012 has been published as a European Standard. DIN EN ISO 15223-1 includes a CD-ROM containing the symbols specified in t
11、he standard, together with examples of their application, in TIF format. Amendments This standard differs from DIN EN ISO 15223-1:2013-02 as follows: a) normative references have been updated; b) the requirements for the symbols 5.1.1, 5.1.2, 5.4.3, 5.4.5 and 5.5.5 have been updated; c) in Annex A,
12、A.15, examples of using symbol 5.4.3 “Consult instructions for use” for an electronic instruction for use (eIFU) have been included; DIN EN ISO 15223-1:2017-04 3 d) Annexes ZA, ZB and ZC concerning the relationship between this European Standard and the essential requirements of EU Directives 93/42/
13、EEC, 90/385/EEC and 98/79/EC on medical devices in general and in vitro diagnostic medical devices have been revised; Previous editions DIN EN 980: 1996-08, 1999-12, 2001-11, 2003-08, 2008-08 DIN EN ISO 15223-1: 2012-10, 2013-02 DIN EN ISO 15223-1:2017-04 4 National Annex NA (informative) Bibliograp
14、hy DIN EN 80416-3, Basic principles for graphical symbols for use on equipment Part 3: Guidelines for the application of graphical symbols DIN EN ISO 7010, Graphical symbols Safety colours and safety signs Registered safety signs DIN EN ISO 14971, Medical devices Application of risk management to me
15、dical devices DIN EN ISO 18113-1, In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 1: Terms, definitions and general requirements DIN EN ISO 18113-2, In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 2: In vitro
16、 diagnostic reagents for professional use DIN EN ISO 18113-3, In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009) DIN EN ISO 18113-4, In vitro diagnostic medical devices Information s
17、upplied by the manufacturer (labelling) Part 4: In vitro diagnostic reagents for self-testing DIN EN ISO 18113-5, In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 5: In vitro diagnostic instruments for self-testing DIN ISO 3864-1 Graphical symbols Safety
18、colours and safety signs Part 1: Design principles for safety signs and safety markings DIN ISO 7000, Graphical symbols for use on equipment Index and synopsis DIN ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times EUROPEAN STANDARD NORME EUROPE
19、NNE 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 (ISO 15223-1:2016, Corrected version 2017-03)
20、Dispositifs mdicaux Symboles utiliser avec les tiquettes, ltiquetage et les informations fournir relatifs aux dispositifs mdicaux Partie 1: Exigences gnrales (ISO 15223-1:2016, Version corrige 2017-03) Medizinprodukte Bei Aufschriften von Medizinprodukten zu verwendende Symbole, Kennzeichnung und zu
21、 liefernde Informationen Teil 1: Allgemeine Anforderungen (ISO 15223-1:2016, korrigierte Fassung 2017-03) 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 thi
22、s 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 thre
23、e 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 th
24、e 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, Neth
25、erlands, Norway, Poland, Portugal, 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
26、 and for CENELEC Members. Ref. No. EN ISO 15223-1:2016 E Foreword 12Introduction .131 Scope 142 Normative references .143 Terms and definitions 144 General requirements 154.1 Proposal of symbols for adoption 154.2 Requirements for usage . 154.3 Other symbols . 165 Symbols . 16Annex A (informative) E
27、xamples .33Annex B (informative) Use of general prohibition symbol and negation symbol.37Bibliography .38Contents PageEuropean foreword 3 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC OJ L 169 on Medical Devices 5 Annex ZB
28、 (informative) Relationship between this European standard and the essential requirements of Directive 90/385/EEC OJ L 189 aimed to be covered 8 Annex ZC (informative) Relationship between this European standard and the essential requirements of Directive 98/79/EC OJ L 331 aimed to be covered 10 .2D
29、IN EN ISO 15223-1:2017-04 EN ISO 15223-1:2016 (E) 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 CEN/CLC/TC 3 “Quality manag
30、ement 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 conflicting national standards s
31、hall 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 supersedes EN ISO 15223-1:2
32、012. 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 ZC, which are integral par
33、ts 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. However, for any use of this
34、 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 referred to in the ISO standa
35、rd 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 determines the extent (in wh
36、ole or in part) to which they apply. Table 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 ISO 14971:2012 ISO 14971:2007
37、 ISO 15223-2 ISO 15223-2:2010 aAvailable only in database format from ISO or IEC. 3DIN EN ISO 15223-1:2017-04 EN ISO 15223-1:2016 (E)According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austr
38、ia, 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
39、, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 15223-1:2016, Corrected version 2016-12-15 has been approved by CEN as EN ISO 15223-1:2016 without any modification. 4DIN EN ISO 15223-1:2017-04 EN ISO 15223-1:2016 (E) Annex ZA (informative) Relationship between this E
40、uropean 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
41、of conforming 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 confe
42、rs, 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. NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk management proce
43、ss needs 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 man
44、ufacturers 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 co
45、re text. 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)
46、/subclause(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, provi
47、ded 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. 5DIN EN ISO 15223-1:2017-04 EN ISO 15223-1:2016 (E)13.3 (a) 5.1.1, 5.1.2 Provided that the symbol is provided on the label and according to the general requirements
48、 indicated 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
49、on the label 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 ER 13.1 of Directive 93/42/EEC, the “use-by” date must be expressed as, at least,
