EN ISO 18113-5-2011 en In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5 In vitro diagnostic instruments for self-testing《体外诊断医疗器械.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 18113-5:2011In vitro diagnostic medicaldevices Information suppliedby the manufacturer (labelling)Part 5: In vitro diagnostic instruments forself-testing (ISO 18113-5:2

2、009)Incorporating corrigendum December 2011BS EN ISO 18113-5:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 18113-5:2011. It is identical to ISO 18113-5:2009. It supersedes BS EN ISO 18113-5:2009, which is withdrawn.The UK participation in its preparat

3、ion was entrusted to Technical Committee CH/212, IVDs.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The Brit

4、ish Standards Institution 2012 ISBN 978 0 580 77330 3ICS 11.100.10 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2011.Amendments/corrgenda issued s

5、ince publicationDate Text affected31 January 2012 Implementation of CEN Correction Notice 9November 2011: Corrected date of withdrawal in EN forewordEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 18113-5 October 2011 ICS 11.100.10 Supersedes EN ISO 18113-5:2009English Version In vitro diag

6、nostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009) Dispositifs mdicaux de diagnostic in vitro - Informations fournies par le fabricant (tiquetage) - Partie 5: Instrumentsde diagnostic in vitro po

7、ur auto-tests (ISO 18113-5:2009) In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 5: 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 compl

8、y 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 standards may be obtained on application to the CEN-CENELEC

9、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 and notified to the CEN-CENELEC Management Centre has the sam

10、e 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, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Po

11、rtugal, 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 2011 CEN All rights of exploitation in any form and by any mea

12、ns reserved worldwide for CEN national Members. Ref. No. EN ISO 18113-5:2011: E3 Forewo rd This document (EN ISO 18113-5:2011) has been prepared by Technical Committee ISO/TC 212 “Clinicallaboratory testing and in vitro diagnostic test sy stems“ in collaboration with Technical Committee CEN/TC 140“I

13、n 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 identicaltext or by endorsement, at the latest by April 2012, and conflicting national standards shall be withdrawn at the

14、latest by October 2014. Attention is drawn to the possibility that some of the elements of this document may be the subject of patentrights. CEN and/or CENELEC shall not be held responsible for identify ing any or all such patent rights. This document supersedes EN ISO 18113-5:2009. This new edition

15、 contains a revised Annex ZA. This document has been prepared under a mandate given to CEN by the European Commission and theEuropean Free Trade Association, and supports essential requirements of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part o

16、f this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cy prus, CzechRepublic, Denmark, Estonia, Finland, France, Germany , Greece, Hungary

17、, 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 has been approved by CEN as EN ISO 18113-5:2011 without any modification

18、. BS EN ISO 18113-5:2011 EN ISO 18113-5:2011 (E)4 A nnex ZA (informativ e) Relationship bet ween this European Standard and the EssentialRequirements of the EU Directive 98/79/EC on “in vitro DiagnosticMedical Devices” This European Standard has been prepared under a mandate given to CEN by the Euro

19、pean Commission toprovide a means of conforming to the Essential Requirements of the New Approach Directive 98/79/EC on “invitro Diagnostic Medical Devices”. Once this European Standard is cited in the Official Journal of the European Union under that Directive andhas been implemented as national st

20、andard in at least one Member State, compliance with the clauses of thisstandard given in Table ZA.1 confers, within the limits of the scope of this European Standard, a presumptionof conformity with the corresponding Essential Requirements of that Directive and associated EFTAregulations. Table ZA

21、.1 Correspondence between this European Standard and European Directive 98/79/EC Clauses of this EuropeanStandard Essential Requirements(ERs) of Directive 98/79/EC Qualifyingcomments/Notes 6, 7.3, 7.11 B.7 These clau ses only cover thesecond sentence of ER B.7,namely the labellingrequirements. NOTE

22、2 7.12 B.7.2 5, 6, 7 B.8.1 Presumption of confor mity w ithER B.8.1 also requirescompliance w ith clau ses 4.1, 4.2.1 and 4.6 of EN ISO 18113-1. 5.2.1 B.8.4(b) 5.2.2 B.8.4(d) Full compliance to ER B.8.4(d)requires the use of EN 980, clause 5.4 symbol (LOT) or EN 980, clause 5.5 symbol(SN), as applic

23、able. 5.2.3 B.8.4(g) 7.3 B.8.5 6, 7.1, 7.2, 7.3, 7.4, 7.5, 7.11 B.8.7(a) Presumption of confor mity w ithER B.8.7(a) requires alsocompliance w ith clau se 4.5 of EN ISO 18113-1. NOTE 1, NOTE 2 7.8 B.8.7(d) 7.2.2, 7.10 B.8.7(e) 7.10 B.8.7(f) 7.11, 7.14, 7.15 B.8.7(g) NOTE 2 7.7, 7.8, 7.9, 7.10, 7.11

24、B.8.7(h) NOTE 2 7.18 B.8.7(j) 7.12, 7.14 B.8.7(k) BS EN ISO 18113-5:2011 EN ISO 18113-5:2011 (E)5 Clauses of this EuropeanStandard Essential Requirements(ERs) of Directive 98/79/EC Qualifyingcomments/Notes 7.6, 7.10 B.8.7(m) 7.6, 7.10, 7.14, 7.16, 7.17 B.8.7(n) 7.10 B.8.7(o) 7.5, 7.16 B.8.7(s) NOTE

25、2 7.7, 7.12, 7.13, 7.14, 7.18, 7.19 B.8.7(t) NOTE 1 In the European Union, the name and address of the manufacturers “EC Authorized representative” isrequired on the outer container label or in the instruction s for use, if the legal manufacturer is not located w ithin theEuropean Union. NOTE 2 Esse

26、ntial Require ment B.8.7 of Directive 98/79/EC should be consulted for a comprehensive list of theinfor mation required. BS EN ISO 18113-5:2011 EN ISO 18113-5:2011 (E)iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative references1 3 Terms and definitions .2 4 Essential requirements.2 5

27、Labels and marking.2 5.1 General .2 5.2 Identification of the IVD instrument.2 6 Elements of the instructions for use .3 7 Content of the instructions for use .3 7.1 Manufacturer3 7.2 Identification of the IVD instrument.3 7.3 Intended use 4 7.4 Storage and handling4 7.5 Warnings and precautions .4

28、7.6 Instrument installation4 7.7 Principles of measurement 5 7.8 Performance of the IVD instrument .5 7.9 Limitations of use5 7.10 Preparation prior to operation .5 7.11 Operating procedure .5 7.12 Control procedure .6 7.13 Reading of examination results .6 7.14 Special functions.6 7.15 Shut-down pr

29、ocedure .6 7.16 Disposal information.6 7.17 Maintenance.7 7.18 Troubleshooting 7 7.19 Follow-up action7 Bibliography8 BS EN ISO 18113-5:2011 EN ISO 18113-5:2011 (E) ISO 2011 iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (I

30、SO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, gov

31、ernmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC

32、 Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the membe

33、r bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 18113-5 was prepared by Technical Committee ISO/TC 212, Clinical laborat

34、ory testing and in vitro diagnostic test systems. ISO 18113 consists of the following parts, under the general 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

35、professional use Part 3: In vitro diagnostic instruments for professional use Part 4: In vitro diagnostic reagents for self-testing Part 5: In vitro diagnostic instruments for self-testing BS EN ISO 18113-5:2011 EN ISO 18113-5:2011 (E) ISO 2011 vIntroduction Manufacturers of in vitro diagnostic (IVD

36、) instruments for self-testing supply users with information to enable the safe use and expected performance of their 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 coun

37、try-specific 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. S

38、ee Reference 7. This part of ISO 18113 provides a basis for harmonization of labelling requirements for IVD instruments 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 co

39、njunction 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 5925. The text has been modified to conform to Part 2 of the ISO/IEC Directives4, but the requirements

40、, 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 enacted or plan to enact labelling regulation

41、s for IVD medical devices. For IVD instruments 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 18113-43. BS EN ISO 18113-5:2011 EN ISO 18113-5:2011 (E) ISO 2011 BS EN ISO 18

42、113-5:2011 EN ISO 18113-5:2011 (E) ISO 2011 INTERNATIONAL STANDARD1In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 5: In vitro diagnostic instruments for self-testing 1 Scope This part of ISO 18113 specifies requirements for information supplied by the m

43、anufacturer of IVD instruments for self-testing. 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 instrumen

44、t servicing or repair, b) IVD reagents, including 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

45、 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 and

46、 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 IEC 61010-1, Safety requirements for electrical equipment for measurement, control and la

47、boratory 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) medical equipment IEC 61326-2-6, Electrical equipment for measurement, control and lab

48、oratory 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 use in the labelling of medical devices EN ISO 18113-5:2011 (E)BS EN ISO 18113-5:2011 ISO 2011 2 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 18113-1 apply