1、January 2013 Translation by DIN-Sprachendienst.English price group 11No 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).IC
2、S 11.100.10!$W3“1935216www.din.deDDIN EN ISO 18113-4In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009);English version EN ISO 18113-4:2011,English translation of DIN EN ISO 18113-4:2013-01I
3、n-vitro-Diagnostika Bereitstellung von Informationen durch den Hersteller Teil 4: Reagenzien fr in-vitro-diagnostische Untersuchungen zur Eigenanwendung(ISO 18113-4:2009);Englische Fassung EN ISO 18113-4:2011,Englische bersetzung von DIN EN ISO 18113-4:2013-01Dispositifs mdicaux de diagnostic in vit
4、ro Informations fournies par le fabricant (tiquetage) Partie 4: Ractifs de diagnostic in vitro pour auto-tests (ISO 18113-4:2009);Version anglaise EN ISO 18113-4:2011,Traduction anglaise de DIN EN ISO 18113-4:2013-01SupersedesDIN EN ISO 18113-4:2010-05See start of applicationwww.beuth.deDocument com
5、prises pagesIn case of doubt, the German-language original shall be considered authoritative.2012.12 DIN EN ISO 18113-4:2013-01 2 A comma is used as the decimal marker. Start of application The start of application of this standard is 2013-01-01. DIN EN ISO 18113-4:2010-05 may be used in parallel un
6、til 2014-10-31. National foreword This standard (EN ISO 18113-4:2011) has been prepared by Technical Committee ISO/TC 212 “Clinical laboratory testing and In-vitro-diagnostic-test systems” in collaboration with Technical Committee CEN/TC 140 “In-vitro-diagnostic medical devices” (Secretariat: DIN, G
7、ermany). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-03-03 AA Qualittsmanagement in medizinischen Laboratorien. DIN EN ISO 18113 consists of the following parts, under the general title In vitro diagn
8、ostic medical devices Information supplied by the manufacturer (labelling): Part 1: Terms, definitions and general requirements Part 2: In vitro diagnostic reagents for professional use Part 3: In vitro diagnostic instruments for professional use Part 4: In vitro diagnostic reagents for self-testing
9、 Part 5: In vitro diagnostic instruments for self-testing The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 14971 DIN EN ISO 14971 ISO 18113-1 DIN EN ISO 18113-1 ISO 18113-5 DIN EN ISO 18113-5 ISO 18153 DIN EN ISO 18153 Amendments This st
10、andard differs from DIN EN ISO 18113-4:2010-05 as follows: a) Annex ZA has been revised and rendered more precise. Previous editions DIN EN 376: 1992-07, 2002-06 DIN EN ISO 18113-4: 2010-05 ISO 15197 DIN EN ISO 15197 ISO 15223-1 DIN ISO 15223-1 DIN EN ISO 18113-4:2013-01 3 National Annex NA (informa
11、tive) Bibliography DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 15197, In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus DIN ISO 15223-1, Medical devices Symbols to be us
12、ed with medical device labels, labelling and information to be supplied Part 1: General requirements 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 18113-5, In vitro diagnosti
13、c medical devices Information supplied by the manufacturer (labelling) Part 5: In vitro diagnostic instruments for self-testing DIN EN ISO 18153, In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values for catalytic concentration of enz
14、ymes assigned to calibrators and control materials DIN EN ISO 18113-4:2013-01 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 18113-4 October 2011 ICS 11.100.10 Supersedes EN ISO 18113-4:2009English Version In vitro diagnostic medical devices - Information
15、 supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009) Dispositifs mdicaux de diagnostic in vitro - Informations fournies par le fabricant (tiquetage) - Partie 4: Ractifs de diagnostic in vitro pour auto-tests (ISO 18113-4:2009) In-vitro-
16、Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 4: Reagenzien fr in-vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO 18113-4:2009) This European Standard was approved by CEN on 20 September 2011. CEN members are bound to comply with the CEN/CENELEC Internal Regul
17、ations 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 membe
18、r. 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 member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CE
19、N members are the national standards bodies 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,
20、Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN nationa
21、l Members. Ref. No. EN ISO 18113-4:2011: EContents DIN EN ISO 18113-4:2013-01 EN ISO 18113-4:2011 (E) Page Foreword3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .5 4 General6 4.1 Essential requirements .6 4.2 Identification of kit components 6 4.3 Presentation of the i
22、nstructions for use .6 5 Content of the outer container label6 5.1 Manufacturer 6 5.2 Identification of the IVD reagent.6 5.3 Contents .7 5.4 Intended use.7 5.5 In vitro diagnostic use.7 5.6 Storage and handling conditions.7 5.7 Expiry date7 5.8 Warnings and precautions8 6 Content of the immediate c
23、ontainer label .8 6.1 General provisions 8 6.2 Manufacturer 8 6.3 Identification of the IVD reagent.8 6.4 Contents .8 6.5 In vitro diagnostic use.8 6.6 Storage and handling conditions.9 6.7 Expiry date9 6.8 Warnings and precautions9 7 Content of the instructions for use9 7.1 Manufacturer 9 7.2 Ident
24、ification of the IVD reagent.9 7.3 Intended use.9 7.4 Principles of the examination method 10 7.5 Components 10 7.6 Additional required equipment 10 7.7 Reagent preparation. 10 7.8 Storage and shelf life after first opening 10 7.9 Warnings and precautions. 10 7.10 Primary sample collection, handling
25、 and storage. 11 7.11 Examination procedure 11 7.12 Control procedure. 11 7.13 Reading of examination results 11 7.14 Interpretation of results . 11 7.15 Performance characteristics . 11 7.16 Biological reference intervals 12 7.17 Limitations of examination procedure 12 7.18 Literature references 12
26、 Bibliography. 13 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of the EU Directive 98/79/EC on “in vitro Diagnostic Medical Devices” 15 2 Foreword This document (EN ISO 18113-4:2011) has been prepared by Technical Committee ISO/TC 212 Clinical lab
27、oratory testing and in vitro diagnostic test systems” in collaboration with Technical Committee CEN/TC 140 “In vitro diagnostic medical devices” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical tex
28、t or by endorsement, at the latest by April 2012, and conflicting national standards shall be withdrawn at the latest by October 2014. 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 responsibl
29、e for identifying any or all such patent rights. This document supersedes EN ISO 18113-4:2009. This new edition contains a revised Annex ZA. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential require
30、ments of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part 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,
31、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, Switzerland and United Kingdom. Endorseme
32、nt notice The text of ISO 18113-4:2009 has been approved by CEN as EN ISO 18113-4:2011 without any modification. “DIN EN ISO 18113-4:2013-01 EN ISO 18113-4:2011 (E) 3 Introduction Manufacturers of in vitro diagnostic (IVD) reagents for self-testing supply users with information to enable the safe us
33、e and expected performance of their devices. The type and level of detail varies according to the intended uses and country-specific regulations. The Global Harmonization Task Force (GHTF) encourages convergence of the evolution of regulatory systems for medical devices at the global level. Eliminat
34、ing differences among regulatory jurisdictions could allow patients earlier access to new technologies and treatments. See Reference 9. This part of ISO 18113 provides a basis for harmonization of labelling requirements for IVD reagents for self-testing. This part of ISO 18113 is concerned solely wi
35、th information supplied with IVD reagents, calibrators and control materials intended for self-testing. It is intended to be used in conjunction with ISO 18113-1, which contains the general requirements for information supplied by the manufacturer and definitions of general labelling concepts. This
36、part of ISO 18113 is based on EN 376:20025. The text has been modified to conform to Part 2 of the ISO/IEC Directives4, but the requirements, including those in ISO 18113-1, are substantially equivalent to the original European harmonized standard. This part of ISO 18113 is intended to support the e
37、ssential labelling requirements of all the GHTF partners, as well as other countries that have enacted or plan to enact labelling regulations for IVD medical devices. For IVD reagents, calibrators and/or control materials that are intended to be used as a system with an instrument provided by the sa
38、me manufacturer, this part of ISO 18113 is also intended to be used together with ISO 18113-1 and ISO 18113-53. DIN EN ISO 18113-4:2013-01 EN ISO 18113-4:2011 (E) 4 1 Scope This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing. Th
39、is part of ISO 18113 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 applies to the labels for outer and immed
40、iate containers and to the instructions for use. This part of ISO 18113 does not apply to: a) IVD instruments or equipment, b) IVD reagents for professional use. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, on
41、ly the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 14971, Medical devices Application of risk management to medical devices ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling a
42、nd information to be supplied Part 1: General requirements ISO 18113-1, In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 1: Terms, definitions and general requirements EN 980, Symbols for use in the labelling of medical devices 3 Terms and definitions For
43、 the purposes of this document, the terms and definitions given in ISO 18113-1 apply. DIN EN ISO 18113-4:2013-01 EN ISO 18113-4:2011 (E) 5 4 General 4.1 Essential requirements The requirements of ISO 18113-1 apply. For the use of symbols, the requirements of ISO 15223-1 and EN 980 apply. ISO standar
44、ds for specific IVD medical devices may also contain requirements for information supplied by the manufacturer. EXAMPLES ISO 151971; ISO 175932. 4.2 Identification of kit components In the case of a kit, each component shall be identified by name, letter, number, symbol, colour or graphics in the sa
45、me manner on all labels and in the instructions for use. 4.3 Presentation of the instructions for use 4.3.1 The instructions for use shall be written to be easily understood and applied by a lay person, and where appropriate, supplemented with drawings and diagrams. Some devices may require separate
46、 information for the healthcare professional. 4.3.2 The information supplied shall be sufficient to enable a lay person to use the IVD reagent safely and properly, and to understand the IVD examination results. NOTE Recommendations for developing user instruction manuals for IVD medical devices used
47、 in home health care are found in Reference 10. 5 Content of the outer container label 5.1 Manufacturer The name and address of the manufacturer shall be given. NOTE In the European Union, the name and address of the manufacturers “EC Authorized Representative” is required on the outer container lab
48、el or in the instructions for use, if the legal manufacturer is not located within the EU. See Reference 8. 5.2 Identification of the IVD reagent 5.2.1 IVD reagent name The name of the IVD reagent shall be given. When the name does not uniquely identify the IVD reagent, an additional means of identification shall also be given. EXAMPLES Catalogue number, commodity number. 5.2.2 Batch code A batch code shall be given. DIN EN ISO 18113-4:2013-01 EN ISO 18113-4:2011 (E) 6 If a kit contains differ
