EN ISO 18113-1-2011 en In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1 Terms definitions and general requirements《体外诊断医疗器械 制造商提供.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 18113-1:2011In vitro diagnostic medicaldevices Information suppliedby the manufacturer (labelling)Part 1: Terms, definitions and generalrequirements (ISO 18113-1:2009)I

2、ncorporating corrigendum December 2011BS EN ISO 18113-1:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 18113-1:2011. It is identical to ISO 18113-1:2009. It supersedes BS EN ISO 18113-1:2009 which is withdrawn.The UK participation in its preparation wa

3、s entrusted to Technical Com-mittee 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 necessary provi-sions of a contract. Users are responsible for its correct application. The British S

4、tandards Institution 2012ISBN 978 0 580 77327 3ICS 11.100.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2011.Amendments/corrigenda issued since pub

5、licationDate T e x t a f f e c t e d31 January 2012 Implementation of CEN correction notice 9November 2011: Corrected date of withdrawalin EN forewordEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 18113-1 October 2011 ICS 11.100.10 Supersedes EN ISO 18113-1:2009English Version In vitro dia

6、gnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) Dispositifs mdicaux de diagnostic in vitro - Informations fournies par le fabricant (tiquetage) - Partie 1: Termes, dfinitions et exigences gnrales

7、(ISO 18113-1:2009) In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 1: Begriffe und allgemeine Anforderungen (ISO 18113-1:2009) This European Standard was approved by CEN on 20 September 2011. CEN members are bound to comply with the CEN/CENELEC Internal Regulation

8、s 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 Centre or to any CEN member. Th

9、is 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 official versions. CEN mem

10、bers 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, Slovakia, Slovenia, Spain

11、, 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 worldwide for CEN national Mem

12、bers. Ref. No. EN ISO 18113-1:2011: E3 Foreword This document (EN ISO 18113-1:2011) 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” the se

13、cretariat 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. Attention is dra

14、wn 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 18113-1:2009. This new edition contains a revised Annex ZA. This docum

15、ent 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. According to the CEN/C

16、ENELEC 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, Latvia, Lithu

17、ania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 18113-1:2009 has been approved by CEN as EN ISO 18113-1:2011 without any modification. BS EN ISO 18113-1:2011 EN ISO 18113-1:

18、2011 (E)4 BS EN ISO 18113-1:2011 EN ISO 18113-1:2011 (E)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” This European Standard has been prepared under a mandate given to CEN by the

19、 European Commission to provide a means of conforming to the Essential Requirements of the New Approach Directive 98/79/EC on “in vitro Diagnostic Medical Devices”. Once this European Standard is cited in the Official Journal of the European Union under that Directive and has been implemented as nat

20、ional standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this European Standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations

21、. Table ZA.1 Correspondence between this European Standard and European Directive 98/79/EC Clauses of this European standard Essential Requirements (ERs) of Directive 98/79/EC Qualifying comments/Notes 4.1, 4.2.1, 4.6 B.8.1. Presumption of conformity with ER B.8.1 also requires compliance with the r

22、elevant clauses of EN ISO 18113-2, -3, -4 and -5, as applicable. Compliance with MEDDEV 2.14/3 “IVD Guidance: Supply of Instructions For Use (IFU) and other information for In vitro Diagnostic (IVD) Medical Devices A Guide for Manufacturers and Notified Bodies“ is required to ensure presumption of c

23、onformity in the case where IFU are provided separately from the IVD device. NOTE 1 4.3 B.8.2. Presumption of conformity with ER B.8.2 also requires compliance with the relevant clauses of EN 980, where applicable. 4.5 B.8.4(c)4.8 B.8.4( j) WARNING Other requirements and other EU Directives may be a

24、pplicable to the product(s) falling within the scope of this European Standard. NOTE 1 MEDDEV 2.14/3 rev 1 (2007) is available from the European Commissions website at the following address: http:/ec.europa.eu/consumers/sectors/medical-devices/files/meddev/2_14_3_rev1_ifu_final_en.pdf . This page de

25、liberately set blankBS EN ISO 18113-1:2011 EN ISO 18113-1:2011 (E)iiiContents PageForeword ivIntroduction.v1Scope12Normative references13Terms and definitions.24General requirements for information supplied by the manufacturer.174.1General .174.2 Language184.3 Symbols and identification colours.184.

26、4 Values and nomenclature.184.5 Microbiological state.184.6 Instructions for use.184.7Changes to the IVD medical device.194.8Disclosure of residual risks.194.9Identification of components.204.10 Assistance20Annex A (informative) Performance characteristicsof IVD medical devices.21Bibliography45BS EN

27、 ISO 18113-1:2011 EN ISO 18113-1:2011 (E) ISO 2011 iv Foreword ISO(the International Organization for Standardization) is a worldwide federation of national standards bodies(ISOmember bodies). The work of preparing International Standards is normally carried out throughISOtechnical committees. Each

28、member bodyinterested in a subject forwhich a technical committee has been established has the right to be represented on that committee. International organizations, governmentaland non-governmental, in liaison with ISO,also take part in the work. ISOcollaborates closely with the International Elec

29、trotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordancewith the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft International Standardsadopted

30、by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval byat 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 ri

31、ghts. ISO shall not be held responsible for identifying any or all such patent rights. ISO18113-1 was prepared by Technical Committee ISO/TC212, Clinical laboratorytesting and in vitrodiagnostic test systems.ISO18113 consists of the following parts, under the general title Invitro diagnostic medical

32、 devicesInformation 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 Part 5: In vi

33、tro diagnostic instruments for self-testing BS EN ISO 18113-1:2011 EN ISO 18113-1:2011 (E) ISO 2011 vIntroduction Manufacturers of in vitro diagnostic (IVD) medical devices supplyusers with information to enable the safeuse and expected performance of their de vices. Traditionally, this inform ation

34、 has been provided in the form of labels, package inserts and user manuals,where the type and level of detail would depend on the intended uses and country-specific regulations. The Global Harmonization Task Force (GHTF) encourages convergence of the evolution of regulatorysystemsfor medical dev ice

35、s at the global level. The goal is to facilitate trade while pres erving the right ofparticipating members to address the protection of public health by regulatory means. Consistent worldwidelabelling requirements offer significant benefits to manufacturers, users, patients and regulatoryauthorities

36、. Eliminating differences among regulatory jurisdictions could allow patients earlier access to newtechno logiesand treatments bydecreasing the time necessary to gain regulatory compliance. See Reference 36. This part of ISO 18113 provides a basis for harmonization of labelling requirements forIVD m

37、edical devices.The GHTF has established guiding principles that apply to the labelling of medical devices. See Reference 36. These principles have been incorporated into the ISO18113 series. Of particular note, GHTF states that country-specific requirements for the content, wording and format of lab

38、els and instructions for use should be kept to a minimum, and eliminated over time as the opportunities arise. This part of ISO18113 contains a comprehensive list of terms and definitions necessary to develop the labelling for IVD medical devices. Internationally agreed-upon definitions of important

39、 concepts promote greater consistencyin IVDmedical device labelling. While the goal is to standardize the terminology used in IVD medical devicelabelling to the extent possible, it is also recognised that current national and regionalusage by medical laboratories, healthcare providers, patients and

40、regulatoryauthorities must be respected. An obstacle to the timely and affordable availabilityofIVD medical devices in some countriesis the requirement forinformation to appear in multiple languages. Wherever practical, GHTF encourages the use of standardized, internationally recognised symbols as l

41、ong as safe use of the device is not compromised by diminished understandingon the part of the user. This part of ISO18113 provides support for the useof symbols consistent with the GHTF objectives.GHTF also encourages manufacturers to employ the most appropriate methods of delivering information. U

42、ntilrecently, most information had been supplied as printed materials accompanying the IVD medical device.Modern technologies enable instructions for use and technical information to be provided using a moreefficient means of delivery.Information can be digitally encoded on magnetic or optical media

43、, displayed on ascreen, incorporated in the device, or even transmitted over the internet at the time of use. These advancesoffer users the possibility of more timely availability of critical information, such as performance changes, andoffermanufacturersmore effective means of disseminating the inf

44、ormation. The ISO18113 series specifies requirements for information supplied by the manufacturer of IVD medical devices. It consists of five parts, allowing it to address the specific needs of professional users and self-testingusers in the most appropriate manner. Furthermore, since manufacturersp

45、rovide different types ofinformation for IVD reagents and instruments, their requirements are addressed in separate parts of the ISO 18113 series. This part of ISO18113 is not intended to be used alone. It contains terms, definitions and general principlesthat applyto all parts of ISO18113. In addit

46、ion, guidelines for the terms and definitions that describe theperformance characteristics of IVD medical devices are given in AnnexA. This information is not repeatedinthe subsequent parts, so this document is indispensable to the application of ISO 18113-2, ISO 18113-3,ISO 18113-4 and ISO 18113-5.

47、 ISO18113-2 specifies the requirements for labels and instructions for use supplied with IVD reagents,calibrators and control materials for professional use. ISO18113-3 specifies therequirements for labels and instructions for use supplied with IVD instruments for professional use. ISO18113-4 specif

48、ies the BS EN ISO 18113-1:2011 EN ISO 18113-1:2011 (E) ISO 2011 vi requirements for labels and instructions for use supplied with IVD reagents, calibrators and control materials for self-testing. ISO 18113-5 specifies the requirements for labels andinstructions for use supplied with IVDinstruments f

49、or self-testing. Parts1, 2 and 3 of ISO18113 are the International Standards necessary for IVD medical devices intended formedical laboratories and other professional uses; Parts 1, 4 and 5 of ISO 18113 are the International Standards necessary for IVD medical devices intended for self-testing. However, re