DIN EN ISO 18113-2-2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2 In vitro diagnostic reagents for professional use (ISO 1.pdf

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!$W4“1935217www.din.deDDIN EN ISO 18113-2Information supplied by the manufacturer (labelling) (ISO 18113-2:2009);English version EN ISO 18113-2:2011,English translation of DIN EN ISO 18113-2:2013-01In-vitro-Diagnostika Bereitstellung von Informationen durch den Hersteller Teil 2: In-vitro

3、-diagnostische Reagenzien fr den Gebrauch durch Fachpersonal(ISO 18113-2:2009);Englische Fassung EN ISO 18113-2:2011,Englische bersetzung von DIN EN ISO 18113-2:2013-01Dispositifs mdicaux de diagnostic in vitro Informations fournies par le fabricant (tiquetage) Partie 2: Ractifs de diagnostic in vit

4、ro usage professionel (ISO 18113-2:2009);Version anglaise EN ISO 18113-2:2011,Traduction anglaise de DIN EN ISO 18113-2:2013-01SupersedesDIN EN ISO 18113-2:2010-05See start of applicationwww.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritat

5、ive.20In vitro diagnostic medical devices Part 2: In vitro diagnostic reagents for professional use 12.12 DIN EN ISO 18113-2:2013-01 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 18113-2:2010-05 may be used in parall

6、el until 2014-10-31. National oreword This standard (EN ISO 18113-2:2011) 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: DI

7、N, Germany). 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 d

8、iagnostic 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-tes

9、ting 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 8601 DIN ISO 8601 ISO 14971 DIN EN ISO 14971 ISO 15223-1 DIN ISO 15223-1 ISO 18113-1 DIN EN ISO 18113-1 ISO 18113-3 DIN EN ISO

10、 18113-3 Amendments This standard differs from DIN EN ISO 18113-2:2010-05 as follows: a) Annex ZA has been revised and rendered more precise. Previous editions DIN EN 375: 1992-07, 2001-06 DIN EN ISO 18113-2: 2010-05 fDIN EN ISO 18113-2:2013-01 3 National Annex NA (informative) Bibliography DIN ISO

11、8601, Data elements and interchange formats Information interchange Representation of dates and times DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be su

12、pplied 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 18113-3, In vitro diagnostic medical devices Information supplied by the manufacturer (label

13、ling) Part 3: In vitro diagnostic instruments for professional use DIN EN ISO 18113-2:2013-01 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 18113-2 October 2011 ICS 11.100.10 Supersedes EN ISO 18113-2:2009English Version In vitro diagnostic medical devic

14、es - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009) Dispositifs mdicaux de diagnostic in vitro - Informations fournies par le fabricant (tiquetage) - Partie 2: Ractifs de diagnostic in vitro usage professionnel (ISO

15、 18113-2:2009) In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 2: In-vitro-diagnostische Reagenzien fr den Gebrauch durch Fachpersonal (ISO 18113-2:2009) This European Standard was approved by CEN on 20 September 2011. CEN members are bound to comply with the CEN/

16、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 Cent

17、re or to any CEN 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 member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the

18、 official versions. CEN 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

19、, Slovakia, Slovenia, 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 wor

20、ldwide for CEN national Members. Ref. No. EN ISO 18113-2:2011: EContents Page 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 5 Content of the outer container label6 5.1 Manufacturer 6 5.2 Identification of

21、 the IVD reagent.6 5.3 Contents .6 5.4 Intended use.6 5.5 In vitro diagnostic use.7 5.6 Storage and handling conditions.7 5.7 Expiry date7 5.8 Warnings and precautions7 6 Content of the immediate container label .7 6.1 General provisions 7 6.2 Manufacturer 8 6.3 Identification of the IVD reagent.8 6

22、.4 Contents .8 6.5 In vitro diagnostic use.8 6.6 Storage and handling conditions.8 6.7 Expiry date8 6.8 Warnings and precautions8 7 Content of the instructions for use9 7.1 Manufacturer 9 7.2 Identification of the IVD reagent.9 7.3 Intended use.9 7.4 Principles of the examination method.9 7.5 Tracea

23、bility of values assigned to calibrators and trueness-control materials9 7.6 Components 10 7.7 Additional required equipment 10 7.8 Reagent preparation. 10 7.9 Storage and shelf life after first opening 10 7.10 Warnings and precautions. 10 7.11 Primary sample collection, handling and storage. 11 7.1

24、2 Examination procedure 11 7.13 Control procedure. 11 7.14 Calculation of examination results . 11 7.15 Interpretation of results . 11 7.16 Performance characteristics . 11 7.17 Biological reference intervals 12 7.18 Limitations of the examination procedure . 12 7.19 Literature references 12 Bibliog

25、raphy. 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 Foreword3 Introduction .4 DIN EN ISO 18113-2:2013-01 EN ISO 18113-2:2011 (E) 2 Foreword This document (EN ISO 18113-2:2

26、011) 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” the secretariat of which is held by DIN. This European Standard shall be given the sta

27、tus of a national standard, either by publication of an identical text 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 subj

28、ect 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 18113-2:2009. This new edition contains a revised Annex ZA. This document has been prepared under a mandate given to CEN by the European Commission an

29、d the European Free Trade Association, and supports essential requirements 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 followi

30、ng countries are bound to implement 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, Slovaki

31、a, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 18113-2:2009 has been approved by CEN as EN ISO 18113-2:2011 without any modification. “DIN EN ISO 18113-2:2013-01 EN ISO 18113-2:2011 (E) 3 Introduction Manufacturers of in vitro diagnostic (IVD) reagents

32、 for professional use supply users with information to enable their safe use and the 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 ev

33、olution of regulatory systems for medical devices at the global level. Eliminating 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 f

34、or IVD reagents for professional use. This part of ISO 18113 is concerned solely with information supplied with IVD reagents, calibrators and control materials intended for professional use. It is intended to be used in conjunction with ISO 18113-1, which contains the general requirements for inform

35、ation supplied by the manufacturer and definitions of general labelling concepts. This part of ISO 18113 is based on EN 375:20015. 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 ori

36、ginal European harmonized standard. This part of ISO 18113 is intended to support the essential labelling requirements of all the GHTF partners, as well as other countries that have or plan to enact labelling regulations for IVD medical devices. For IVD reagents, calibrators and/or control materials

37、 that are intended to be used as a system with an instrument provided by the same manufacturer, this part of ISO 18113 is also intended to be used together with ISO 18113-1 and ISO 18113-32. DIN EN ISO 18113-2:2013-01 EN ISO 18113-2:2011 (E) 4 1 Scope This part of ISO 18113 specifies requirements fo

38、r information supplied by the manufacturer of IVD reagents for professional use. This 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 professional use. This part of ISO 18113 can also be a

39、pplied to accessories. This part of ISO 18113 applies to the labels for outer and immediate 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 self-testing. 2 Normative references The following referenced document

40、s are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 8601, Data elements and interchange formats Information interchange Representa

41、tion of dates and times 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 and information to be supplied Part 1: General requirements ISO 18113-1:, In vitro diagnostic medical devices Inf

42、ormation 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 the purposes of this document, the terms and definitions given in ISO 18113-1 apply. DIN EN ISO 18113-2:2013-0

43、1 EN ISO 18113-2:2011 (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. 4.2 Identification of kit components In the case of a kit, each component shall be identified by name, letter, number, sym

44、bol, colour or graphics in the same manner on all labels and in the instructions for use. 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 Representati

45、ve” is required on the outer container label 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

46、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. If a kit contains different components bearing different batch codes, the batch code indicated on the outer container shall enable the in

47、dividual batch code of each component to be traced from the manufacturers production record. 5.3 Contents The mass, volume, volume after reconstitution and/or the number of examinations shall be indicated. 5.4 Intended use If the intended use is not indicated by the name of the IVD reagent, then an

48、abbreviated intended use statement shall be given or included in the instructions for use. EXAMPLE For measurement of plasma glucose concentration. DIN EN ISO 18113-2:2013-01 EN ISO 18113-2:2011 (E) 6 5.5 In vitro diagnostic use The in vitro diagnostic use of the reagent shall be indicated. EXAMPLES “For in vitro diagnostic use” or graphical symbol: “in vitro diagnostic medical device”. 5.6 Storage and handling conditions The storage conditions necessary to maintain the stability of the rea