DIN EN ISO 18113-3-2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3 In vitro diagnostic instruments for professional use (IS.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!$W7“1935220www.din.deDDIN EN ISO 18113-3In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 3: In vitro diagnostic instruments for professional use(ISO 18113-3:2009);English version EN ISO 18113-3:2011,English translation of DIN EN ISO 18113-3:20

3、13-01In-vitro-Diagnostika Bereitstellung von Informationen durch den Hersteller Teil 3: Gerte fr in-vitro-diagnostische Untersuchungen zum Gebrauch durchFachpersonal (ISO 18113-3:2009);Englische Fassung EN ISO 18113-3:2011,Englische bersetzung von DIN EN ISO 18113-3:2013-01Dispositifs mdicaux de dia

4、gnostic in vitro Informations fournies par le fabricant (tiquetage) Partie 3: Instruments de diagnostic in vitro usage professionel (ISO 18113-3:2009);Version anglaise EN ISO 18113-3:2011,Traduction anglaise de DIN EN ISO 18113-3:2013-01SupersedesDIN EN ISO 18113-3:2010-05See start of applicationwww

5、.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.1912.12 DIN EN ISO 18113-3:2013-01 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 18113-3:2010-05 may b

6、e used in parallel until 2014-10-31. National foreword This standard (EN ISO 18113-3:2011) 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”

7、 (Secretariat: DIN, 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

8、 title In vitro diagnostic 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 reag

9、ents for self-testing 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 15223-1 DIN ISO 15223-1 ISO 18113-1 DIN EN ISO 18113-1 ISO 18113-2 DIN EN ISO 18113-2

10、 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 18113-3:2010-05 as follows: a) Annex ZA has been revised and rendered more precise. Previous editions DIN EN 591: 1994-11, 2001-07 DIN EN ISO 18113-3: 2010-05 DIN EN ISO

11、 18113-3:2013-01 3 National Annex NA (informative) Bibliography 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 supplied Part 1: General requirements DI

12、N 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 devicess Information supplied by the manufacturer (labelling) Part 2: In vitro diagnostic rea

13、gents for professional use DIN EN 61010-1, Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1: General requirements DIN EN 61326-2-6, Electrical equipment for measurement, control and laboratory use EMC requirements Part 2-6: Particular requirements In v

14、itro diagnostic (IVD) medical equipment DIN EN 62366, Medical devices Application of usability engineering to medical devices DIN EN ISO 18113-3:2013-01 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 18113-3 October 2011 ICS 11.100.10 Supersedes EN ISO 18

15、113-3:2009English Version In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009) Dispositifs mdicaux de diagnostic in vitro - Informations fournies par le fabricant (tiquetage) - Par

16、tie 3: Instruments de diagnostic in vitro usage professionnel (ISO 18113-3:2009) In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 3: Gerte fr in-vitro-diagnostische Untersuchungen zum Gebrauch durch Fachpersonal (ISO 18113-3:2009) This European Standard was approve

17、d 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 of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national

18、 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, German). A version in any other language made by translation under the responsibility of a CEN member into its own language

19、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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,

20、Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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 2

21、011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 18113-3:2011: EContents Page Foreword3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .6 4 Essential requirements .6 5 Labels and marking .6 5.1 Ge

22、neral6 5.2 Identification of the IVD instrument.6 6 Elements of the instructions for use .6 7 Content of the instructions for use7 7.1 Manufacturer 7 7.2 Identification of the IVD instrument.7 7.3 Intended use.7 7.4 Storage and handling 8 7.5 Warnings and precautions8 7.6 Instrument installation 8 7

23、.7 Theory of operation .9 7.8 Functions9 7.9 Performance of the IVD instrument .9 7.10 Limitations of use . 10 7.11 Preparation prior to operation. 10 7.12 Operating procedure 10 7.13 Control procedure. 10 7.14 Calculation of examination results . 10 7.15 Special functions 11 7.16 Emergency primary

24、samples. 11 7.17 Shut-down procedure. 11 7.18 Disposal information 11 7.19 Maintenance 11 7.20 Troubleshooting 12 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” 1

25、4 EN ISO 18113-3:2011 (E) DIN EN ISO 18113-3:2013-01 2 Foreword This document (EN ISO 18113-3:2011) 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 d

26、evices” 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 April 2012, and conflicting national standards shall be withdrawn at the latest by October 2014. At

27、tention 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 18113-3:2009. This new edition contains a revised Annex

28、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 relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. Accordin

29、g 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, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,

30、 Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 18113-3:2009 has been approved by CEN as EN ISO 18113-3:2011 without any modification. ”“EN ISO 18113-3:2011 (E

31、) DIN EN ISO 18113-3:2013-01 3 Introduction Manufacturers of in vitro diagnostic (IVD) instruments for professional use supply users with information to enable the safe use and expected performance of their devices. The type and level of detail varies according to the intended uses and country-speci

32、fic regulations. The Global Harmonization Task Force (GHTF) encourages convergence of the evolution 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 Refere

33、nce 5. This part of ISO 18113 provides a basis for harmonization of labelling requirements for IVD instruments for professional use. This part of ISO 18113 is concerned solely with information supplied with IVD instruments and equipment intended for professional use. It is intended to be used in con

34、junction with ISO 18113-1, which contains the general requirements for information supplied by the manufacturer and definitions of general labelling concepts. This part of ISO 18113 is based on EN 5913. The text has been modified to conform to Part 2 of the ISO/IEC Directives2, but the requirements

35、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 essential labelling requirements of all the GHTF partners, as well as other countries that have or plan to enact labelling regulations for IVD

36、medical devices. For IVD instruments for professional use that are intended to be used as a system with reagents provided by the same manufacturer, this part of ISO 18113 is also intended to be used together with ISO 18113-1 and ISO 18113-21. EN ISO 18113-3:2011 (E) DIN EN ISO 18113-3:2013-01 4 1 Sc

37、ope This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for professional use. This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for professional use. This part of ISO 18113 can also be app

38、lied to accessories. This part of ISO 18113 does not apply to: a) instructions for instrument servicing or repair, b) IVD reagents, including calibrators and control materials for use in control of the reagent, c) IVD instruments for self-testing. 2 Normative references The following referenced docu

39、ments 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 14971, Medical devices Application of risk management to medical devices I

40、SO 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 Information supplied by the manufacturer (labelling) Part 1: Terms, definitions and general requirements I

41、EC 61010-1, Safety requirements for electrical equipment for measurement, control and laboratory use Part 1: General requirements IEC 61010-2-101, Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-101: Particular requirements for in vitro diagnostic (IVD

42、) medical equipment IEC 61326-2-6, Electrical equipment for measurement, control and laboratory use EMC requirements Part 2-6: Particular requirements In vitro diagnostic (IVD) medical equipment IEC 62366, Medical devices Application of usability engineering to medical devices EN 980, Symbols for us

43、e in the labelling of medical devices EN ISO 18113-3:2011 (E) DIN EN ISO 18113-3:2013-01 5 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 18113-1 apply. 4 Essential requirements The requirements of ISO 18113-1 apply. 5 Labels and marking 5.1 General

44、 The requirements of IEC 61010-1, IEC 61010-2-101 and IEC 61326-2-6 concerning labels and marking 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 instrument shall be given. When th

45、e 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. All instruments covered by the IEC 61010 series require serial

46、numbers. Where serial numbers are not practical for apparatus, equipment or accessories intented 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 diagnostic use of the ins

47、trument shall be indicated when required by regulation. EXAMPLES The words “for in vitro diagnostic use” or graphical symbol: “in vitro diagnostic medical device”. 6 Elements of the instructions for use The instructions for use for professional use instruments shall include the following, where appr

48、opriate: a) table of contents; b) overview of operating elements; c) flow and block diagrams of instrument configuration; EN ISO 18113-3:2011 (E) DIN EN ISO 18113-3:2013-01 6 d) integration and arrangement of text and illustrations; e) graphic emphasis of warnings; f) examples of how to use the instrument; g) diagrams of procedural steps; h) list of accessories; i) references to relevant scientific literature; j) an index; k) version control identification and first date of applica