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!$W2“1935215www.din.deDDIN EN ISO 18113-5In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 5: In vitro diagnostic instruments for self-testing(ISO 18113-5:2009);English version EN ISO 18113-5:2011,English translation of DIN EN ISO 18113-5:2013-0
3、1In-vitro-Diagnostika Bereitstellung von Informationen durch den Hersteller Teil 5: Gerte fr in-vitro-diagnostische Untersuchungen zur Eigenanwendung(ISO 18113-5:2009);Englische Fassung EN ISO 18113-5:2011,Englische bersetzung von DIN EN ISO 18113-5:2013-01Dispositifs mdicaux de diagnostic in vitro
4、Informations fournies par le fabricant (tiquetage) Partie 5: Instruments de diagnostic in vitro pour auto-tests (ISO 18113-5:2009);Version anglaise EN ISO 18113-5:2011,Traduction anglaise de DIN EN ISO 18113-5:2013-01SupersedesDIN EN ISO 18113-5:2010-05See start of applicationwww.beuth.deDocument co
5、mprises pagesIn case of doubt, the German-language original shall be considered authoritative.1812.12 DIN EN ISO 18113-5:2013-01 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 18113-5:2010-05 may be used in parallel u
6、ntil 2014-10-31. National oreword This standard (EN ISO 18113-5:2011) 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 ISO 14971 ISO 15197 DIN EN ISO 15197 ISO 15223-1 DIN ISO 15223-1 ISO 18113-1 DIN EN ISO 18113-1 ISO 18113-4 DIN EN ISO 1
10、8113-4 IEC 61010-1 DIN EN 61010-1 IEC 61326-2-6 DIN EN 61326-2-6 IEC 62366 DIN EN 62366 Amendments This standard differs from DIN EN ISO 18113-5:2010-05 as follows: a) Annex ZA has been revised and rendered more precise. Previous editions DIN EN 592: 1994-11, 2002-05 DIN EN ISO 18113-5: 2010-05 fDIN
11、 EN ISO 18113-5:2013-01 3 National Annex NA (informative) 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 mellit
12、us DIN ISO 15223-1, Medical devices Symbols to be used 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
13、 requirements DIN EN ISO 18113-4, In vitro diagnostic medical devicess Information supplied by the manufacturer (labelling) Part 4: In vitro diagnostic reagents for self-testing DIN EN 61010-1, Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1: General
14、requirements DIN EN 61326-2-6, Electrical equipment for measurement, control and laboratory use EMC requirements Part 2-6: Particular requirements In vitro diagnostic (IVD) medical equipment DIN EN 62366, Medical devices Application of usability engineering to medical devices DIN EN ISO 18113-5:2013
15、-01 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 18113-5 October 2011 ICS 11.100.10 Supersedes EN ISO 18113-5:2009English Version In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic in
16、struments for self-testing (ISO 18113-5:2009) Dispositifs mdicaux de diagnostic - Informations fournies par le fabricant (tiquetage) - Partie 5: Instruments de diagnostic n vitro pour auto-tests (ISO 18113-5:2009) In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 5:
17、 Gerte fr in-vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO 18113-5:2009) This European Standard was approved by CEN on 20 September 2011. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status
18、 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 member. This European Standard exists in three official versions (English, French, Germ
19、an). 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. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia
20、, 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. EUROPEAN COMMITTEE FOR STANDARDIZAT
21、ION 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 national Members. Ref. No. EN ISO 18113-5:2011: Ein vitroiContents Page Foreword3 Introdu
22、ction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .6 4 Essential requirements .6 5 Labels and marking .6 5.1 General6 5.2 Identification of the IVD instrument.6 6 Elements of the instructions for use .7 7 Content of the instructions for use7 7.1 Manufacturer 7 7.2 Identification of
23、 the IVD instrument.7 7.3 Intended use.8 7.4 Storage and handling 8 7.5 Warnings and precautions8 7.6 Instrument installation 8 7.7 Principles of measurement.9 7.8 Performance of the IVD instrument .9 7.9 Limitations of use 9 7.10 Preparation prior to operation9 7.11 Operating procedure .9 7.12 Cont
24、rol procedure. 10 7.13 Reading of examination results 10 7.14 Special functions 10 7.15 Shut-down procedure. 10 7.16 Disposal information 10 7.17 Maintenance 11 7.18 Troubleshooting 11 7.19 Follow-up action . 11 Bibliography. 12 Annex ZA (informative) Relationship between this European Standard and
25、the Essential Requirements of the EU Directive 98/79/EC on “in vitro Diagnostic Medical Devices” 13 DIN EN ISO 18113-5:2013-01 EN ISO 18113-5:2011 (E) 2 Foreword This document (EN ISO 18113-5:2011) has been prepared by Technical Committee ISO/TC 212 Clinical laboratory testing and in vitro diagnosti
26、c 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 text or by endorsement, at the latest by
27、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 responsible for identifying any or all such pate
28、nt rights. This document supersedes EN ISO 18113-5:2009. 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 requirements of EU Directive. For relationshi
29、p 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, Belgium, Bulgaria, Croatia, Cyprus, Cz
30、ech 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. Endorsement notice The text of ISO 18113-5:2009
31、 has been approved by CEN as EN ISO 18113-5:2011 without any modification. “DIN EN ISO 18113-5:2013-01 EN ISO 18113-5:2011 (E) 3 Introduction Manufacturers of in vitro diagnostic (IVD) instruments for self-testing supply users with information to enable the safe use and expected performance of their
32、 devices. Adequate instructions for use are essential for the safe and proper operation of IVD instruments. 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 regul
33、atory 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 7. This part of ISO 18113 provides a basis for harmonization of labelling requirements for IVD instrumen
34、ts for self-testing. This part of ISO 18113 is concerned solely with information supplied with IVD instruments and equipment 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
35、definitions of general labelling concepts. This part of ISO 18113 is based on EN 5925. 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 par
36、t of ISO 18113 is intended to support the essential 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 instruments that are intended to be used as a system with reagents provided by the
37、 same manufacturer, this part of ISO 18113 is also intended to be used together with ISO 18113-1 and ISO 18113-43. DIN EN ISO 18113-5:2013-01 EN ISO 18113-5:2011 (E) 4 1 Scope This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for self-testi
38、ng. This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 does not apply to a) instructions for instrument servicing or repair, b) IVD reagents, inclu
39、ding calibrators and control materials for use in control of the reagent, c) IVD instruments for professional use. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated refer
40、ences, 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 and information to be supplied Part 1: General r
41、equirements ISO 18113-1, In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 1: Terms, definitions and general requirements IEC 61010-1, Safety requirements for electrical equipment for measurement, control and laboratory use Part 1: General requirements IEC
42、 61010-2-101, Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment IEC 61326-2-6, Electrical equipment for measurement, control and laboratory use EMC requirements Part 2-6: Partic
43、ular requirements In vitro diagnostic (IVD) medical equipment IEC 62366, Medical devices Application of usability engineering to medical devices EN 980, Symbols for use in the labelling of medical devices DIN EN ISO 18113-5:2013-01 EN ISO 18113-5:2011 (E) 5 3 Terms and definitions For the purposes o
44、f this document, the terms and definitions given in ISO 18113-1 apply. 4 Essential requirements The requirements of ISO 18113-1 apply. ISO standards for specific IVD medical devices may also contain requirements for information supplied by the manufacturer. EXAMPLES ISO 151971; ISO 17593, 2. 5 Label
45、s and marking 5.1 General The requirements of IEC 61010-1, IEC 61010-2-101 and IEC 61326-2-6 concerning labels and markings apply. For the use of symbols, the requirements of ISO 15223-1 and EN 980 apply. 5.2 Identification of the IVD instrument 5.2.1 IVD instrument name The name of the IVD instrume
46、nt shall be given. When the name does not uniquely identify the IVD instrument, an additional means of identification shall also be given. EXAMPLES Catalogue number, commodity number. 5.2.2 Serial number A unique serial number shall be given for IVD instruments. NOTE All instruments covered by IEC 6
47、1010 require serial numbers. Where serial numbers are not practical for apparatus, equipment or accessories intended to be used with IVD instruments, a batch code may be used instead. EXAMPLE A primary sample receptacle would be assigned a batch code. 5.2.3 In vitro diagnostic use The in vitro diagn
48、ostic use of the instrument shall be indicated when required by regulation. EXAMPLES “For in vitro diagnostic use” or graphical symbol: “in vitro diagnostic medical device”. DIN EN ISO 18113-5:2013-01 EN ISO 18113-5:2011 (E) 6 6 Elements of the instructions for use IVD instruments for self-testing shall be supplied with easy to understand instructions for use. The instructions for use for IVD instruments for self-testing shall include the following, where appropriate: a) table of
