EN ISO 18113-3-2011 en In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3 In vitro diagnostic instruments for professional use《体外诊断.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 18113-3:2011In vitro diagnostic medicaldevices Information suppliedby the manufacturer (labelling)Part 3: In vitro diagnostic instruments forprofessional use (ISO 18113

2、-3:2009)BS EN ISO 18113-3:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO18113-3:2011. It is identical to ISO 18113-3:2009. It supersedes BS ENISO 18113-3:2009 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommitte

3、e CH/212, IVDs.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 76942 9ICS 11.100.10Complia

4、nce with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 November 2011.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN

5、 ISO 18113-3 October 2011 ICS 11.100.10 Supersedes EN ISO 18113-3:2009English 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 vitr

6、o - Informations fournies par le fabricant (tiquetage) - Partie 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 Fachpe

7、rsonal (ISO 18113-3:2009) 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 of a national standard without any alteration. Up-to-date l

8、ists 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, German). A version in any other language made by translation und

9、er 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,

10、 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 STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NO

11、RMUNG 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 18113-3:2011: EBS EN ISO 18113-3:2011EN ISO 18113-3:2011 (E) 3 Foreword This document (EN ISO 18113-3:2011) has bee

12、n 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 status of a na

13、tional 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 subject of pate

14、nt 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 ZA. This document has been prepared under a mandate given to CEN by the European Commission and the Europ

15、ean 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 following countrie

16、s 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, Slovakia, Slovenia

17、, 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. BS EN ISO 18113-3:2011EN ISO 18113-3:2011 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essent

18、ial Requirements of the EU Directive 98/79/EC on “in vitro Diagnostic Medical Devices” This European Standard has been prepared under a mandate given to CEN by the European Commission to provide a means of conforming to the Essential Requirements of the New Approach Directive 98/79/EC on “in vitro D

19、iagnostic Medical Devices”. Once this European Standard is cited in the Official Journal of the European Union under that Directive and has been implemented as national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits

20、of the scope of this European Standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and European Directive 98/79/EC Clauses of this European Standard Essential Re

21、quirements (ERs) of Directive 98/79/EC Qualifying comments/Notes 5, 6, 7 B.8.1 Presumption of conformity with ER B.8.1 also requires compliance with clauses 4.1, 4.2.1 and 4.6 of EN ISO 18113-1. 7.1 B.8.4(a)NOTE 1 5.2.1 B.8.4(b) 5.2.2 B.8.4(d) Full compliance with ER B.8.4(d) requires the use of EN

22、980, clause 5.4, symbol LOT or EN 980, clause 5.5, symbol SN, as applicable. 5.2.3 B.8.4(g) 7.3 B. 8.5 7.1, 7.2.1, 7.3, 7.4, 7.5, 7.12 B.8.7(a) Presumption of conformity with ER B.8.7(a) requires compliance also with clause 4.5 of EN ISO 18113-1. NOTE 1 NOTE 2 7.9. B.8.7(d) 7.2.2, 7.11, 7.12 B.8.7(e

23、) 7.11, 7.12 B.8.7(f) 7.12, 7.15, 7.17 B.8.7(g) 7.7, 7.8, 7.9, 7.10, 7.11, 7.12 B.8.7(h) 7.14 B.8.7(i) 7.20 B.8.7(j) 7.13 B.8.7(k) 7.6, 7.11, 7.12 B.8.7(m) 7.6, 7.11, 7.12, 7.13, 7.18, 7.19 B.8.7(n) 7.11 B.8.7(o) BS EN ISO 18113-3:2011EN ISO 18113-3:2011 (E) 5 Clauses of this European Standard Essen

24、tial Requirements (ERs) of Directive 98/79/EC Qualifying comments/Notes 7.19 B.8.7(p) 7.19 B.8.7(q) This clause covers only partially ER B.8.7(q), namely only the information about cleaning, decontamination or disinfection. Any other information related to reuse and restrictions on the number of reu

25、se does not apply to this kind of IVD medical device. 7.5, 7.6.3, 7.11 B.8.7(r) NOTE 2 7.5, 7.18 B.8.7(s) NOTE 2 NOTE 1 In the European Union, the name and address of the manufacturers “EC Authorized representative” is required on the outer container label or in the instructions for use, if the lega

26、l manufacturer is not located within the European Union. NOTE 2 Essential Requirement B.8.7 of Directive 98/79/EC should be consulted for a comprehensive list of the information required. BS EN ISO 18113-3:2011ISO 18113-3:2009(E) ISO 2009 All rights reserved iiiContents Page Foreword iv Introduction

27、.v 1 Scope1 2 Normative references1 3 Terms and definitions .2 4 Essential requirements.2 5 Labels and marking.2 5.1 General .2 5.2 Identification of the IVD instrument.2 6 Elements of the instructions for use .2 7 Content of the instructions for use .3 7.1 Manufacturer3 7.2 Identification of the IV

28、D instrument.3 7.3 Intended use 3 7.4 Storage and handling4 7.5 Warnings and precautions .4 7.6 Instrument installation4 7.7 Theory of operation.5 7.8 Functions5 7.9 Performance of the IVD instrument .5 7.10 Limitations of use6 7.11 Preparation prior to operation .6 7.12 Operating procedure .6 7.13

29、Control procedure .6 7.14 Calculation of examination results6 7.15 Special functions.7 7.16 Emergency primary samples .7 7.17 Shut-down procedure .7 7.18 Disposal information.7 7.19 Maintenance.7 7.20 Troubleshooting 8 Bibliography9 BS EN ISO 18113-3:2011ISO 18113-3:2009(E) iv ISO 2009 All rights re

30、servedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for whi

31、ch a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all m

32、atters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are cir

33、culated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member 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 respon

34、sible for identifying any or all such patent rights. ISO 18113-3 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems. ISO 18113 consists of the following parts, under the general title In vitro diagnostic medical devices Information suppli

35、ed 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 Part 5: In vitro diagnostic instruments

36、 for self-testing BS EN ISO 18113-3:2011ISO 18113-3:2009(E) ISO 2009 All rights reserved vIntroduction 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 det

37、ail 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. Eliminating differences among regulatory jurisdictions could allow patients ea

38、rlier access to new technologies and treatments. See Reference 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 inte

39、nded for professional use. 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 part of ISO 18113 is based on EN 5913. The text has been modified to conform

40、to Part 2 of the ISO/IEC Directives2, 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 essential labelling requirements of all the GHTF partners, as well as other countrie

41、s that have or plan to enact labelling regulations for IVD 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

42、. BS EN ISO 18113-3:2011BS EN ISO 18113-3:2011INTERNATIONAL STANDARD ISO 18113-3:2009(E) ISO 2009 All rights reserved 1In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 3: In vitro diagnostic instruments for professional use 1 Scope This part of ISO 18113

43、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 applied to accessories. This p

44、art 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 documents are indispensable for

45、 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 ISO 15223-1, Medical devices

46、 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 IEC 61010-1, Safety requirem

47、ents 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) medical equipment IEC 613

48、26-2-6, 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 use in the labelling of medic

49、al devices BS EN ISO 18113-3:2011ISO 18113-3:2009(E) 2 ISO 2009 All rights reserved3 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 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 th