1、BRITISH STANDARD BS EN 13612:2002 Incorporating Corrigendum No. 1 Performance evaluation of in vitro diagnostic medical devices The European Standard EN 13612:2002 has the status of a British Standard ICS 11.100 BS EN 13612:2002 This British Standard, having been prepared under the direction of the
2、Health and Environment Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strategy Committee on 7 May 2002 BSI 27 February 2003 ISBN 0 580 39650 9 National foreword This British Standard is the official English language version of EN 13612:2002, inclu
3、ding Corrigendum December 2002 The UK participation in its preparation was entrusted to Technical Committee CH/69, In vitro diagnostic systems, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The Bri
4、tish Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards On
5、line. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the respons
6、ible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title
7、 page, pages 2 to 15 and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date Comments 14302 Corrigendum No. 1 27 February 2003 Changes to 2.6, 2.14, 4.5, Annex ZA and BibliographyEUROPEAN STAND
8、ARD NORME EUROPENNE EUROPISCHE NORM EN 13612 March 2002 ICS 11.100 Incorporates corrigendum December 2002 English version Performance evaluation of in vitro diagnostic medical devices Dtermination des performances des dispositifs mdicaux pour diagnostic in vitro Leistungsbewertung von In-vitro-Diagn
9、ostika This European Standard was approved by CEN on 5 January 2002. 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 bibliographic
10、al references concerning such national standards may be obtained on application to the 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 mem
11、ber into its own language and notified to the Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway,
12、 Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2002 CEN All rights of exploitation in any form and by any means reserved worldwide fo
13、r CEN national Members. Ref. No. EN 13612:2002 EEN 13612:2002 (E) 2 Contents page Foreword 3 Introduction 4 1 Scope 5 2 Terms and definitions . 5 3 General requirements for the performance evaluation . 6 3.1 Responsibilities and resources. 6 3.2 Documentation . 7 3.3 Final assessment and review . 7
14、4 Organisation of a performance evaluation study. 7 4.1 Preconditions 7 4.2 Evaluation plan . 7 4.3 Sites and resources 8 4.4 Basic design information 8 4.5 Experimental design. 9 4.6 Performance study records 9 4.7 Observations and unexpected outcomes.10 4.8 Evaluation report 10 5 Modifications dur
15、ing the performance evaluation study 10 6 Re-evaluation . 10 7 Protection and safety of probands 11 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives . 12 Bibliography. 13EN 13612:2002 (E) 3 Foreword This document EN 13612
16、:2002 has been prepared by Technical Committee CEN/TC 140 “In vitro diagnostic medical devices“, the secretariat of which is held by DIN. The European Diagnostic Manufacturers Association (EDMA) has contributed to its preparation. This European Standard shall be given the status of a national standa
17、rd, either by publication of an identical text or by endorsement, at the latest by September 2002, and conflicting national standards shall be withdrawn at the latest by September 2002. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trad
18、e Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this document. Annex ZA is for information only. This standard includes a Bibliography. According to the CEN/CENELEC Internal Regulatio
19、ns, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and th
20、e United Kingdom.EN 13612:2002 (E) 4 Introduction Directive 98/79/EC on in vitro diagnostic medical devices (IVD MDs) requires in Annex III, section 3, indent 11 and section 6.1, in Annex IV, section 3.2 c) and in Annex V, section 3, that the manufacturer provides evidence in his technical documenta
21、tion that the IVD MD performs as claimed, whether these claims are of a technical, analytical or diagnostic nature. Such evidence can be shown by data already available to the manufacturer or by scientific literature or by data originating from performance evaluation studies in a clinical or other a
22、ppropriate environment in accordance with the intended use. If a performance evaluation study is necessary and appropriate to support performance claims of the IVD MD, this standard describes how the manufacturer can fulfil his obligation to conduct a scientifically sound performance evaluation stud
23、y. The evaluation plan is adapted to the nature of the IVD MD and its intended use, taking into account the various recommendations given in standards and scientific literature. Considering the broad range of IVD MDs covered by Directive 98/79/EC and taking into account that, up to now, there is no
24、uniformly applicable document, it is the purpose of this standard to present the common elements to be considered for a performance evaluation. The applicability of many items described will depend on the level of complexity of the IVD MD. At the time of drafting this standard it was envisaged that
25、the European Commission would publish a number of Common Technical Specifications (CTSs) which would be relevant to Directive 98/79/EC on in vitro diagnostic medical devices. It was further envisaged that these would be referenced in the Official Journal of the European Communities. In particular th
26、ese CTSs will apply to in vitro diagnostic medical devices falling into list A of annex II of the Directive 98/79/EC and possibly a number of in vitro diagnostic medical devices in list B of annex II of the same directive. Manufacturers should therefore take these CTSs into account within the contex
27、t of Article 5 “Reference to standards”, of the Directive 98/79/EC.EN 13612:2002 (E) 5 1 Scope This European Standard applies to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. It specifies the responsibilities and general requirements
28、for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer. It does not apply to specific evaluation plans for certain IVD MDs or a specific use. NOTE For a selection of publications on specific evaluation plans see Bibliography. Where a manufacture
29、r maintains a quality system this standard addresses the compliance with “design validation“ and “design changes“ as described in EN ISO 9001, EN 46001 and EN 928 especially considering the nature and use of IVD MDs. In particular, this standard applies to IVD MDs to - show evidence to notified bodi
30、es and national authorities by results of a performance evaluation that the IVD MD performs as claimed by the manufacturer, - establish adequate performance evaluation data originating from appropriate studies or resulting from available literature, and to - satisfy the requirements of a quality sys
31、tem for design validation. 2 Terms and definitions For the purposes of this European Standard, the following terms and definitions apply. 2.1 co-ordinator of a performance evaluation study person empowered by the manufacturer with responsibility for the entire performance evaluation study of an in v
32、itro diagnostic medical device 2.2 drop out specimen or proband that had been selected for a performance evaluation study, but cannot be investigated as planned 2.3 evaluation plan description of a planned performance evaluation study 2.4 evaluation report description of and conclusions from a perfo
33、rmance evaluation study 2.5 investigator person responsible for the execution of the performance evaluation at a certain location 2.6 lay person individual who does not have specific medical education EN 376:2002EN 13612:2002 (E) 6 2.7 performance claim specification in regard to the performance of
34、an in vitro diagnostic medical device laid down in the information supplied by the manufacturer 2.8 performance evaluation investigation of the performance of an in vitro diagnostic medical device based upon data already available, scientific literature and/or performance evaluation studies 2.9 perf
35、ormance evaluation study investigation of an in vitro diagnostic medical device intended to validate the performance claims under the anticipated conditions of use 2.10 performance of an in vitro diagnostic medical device set of properties of an in vitro diagnostic medical device related to its suit
36、ability for the intended purpose 2.11 performance study records documentation of the experimental steps during the performance evaluation study and results obtained 2.12 proband of a performance evaluation study individual being part of a study in order to obtain specimen(s) with defined characteris
37、tics to be used for the performance evaluation study 2.13 tutor person responsible for the supervision of lay persons involved in the performance evaluation study 2.14 validation confirmation , through the provision of objective evidence that the requirements for a specific intended use or applicati
38、on have been fulfilled NOTE 1 The term “validated” is used to designate the corresponding status. NOTE 2 The use conditions for validation can be real or simulated. EN lISO 9000:2000, 3.8.5 3 General requirements for the performance evaluation 3.1 Responsibilities and resources The manufacturer take
39、s the responsibility for the initiation and/or the conduct of a performance evaluation study. He shall define the responsibility and the interrelation of all personnel who manage and conduct the performance evaluation of IVD MDs, particularly for personnel who need the organisational freedom and aut
40、hority toEN 13612:2002 (E) 7 a) assess the validity of test results and data already available; b) specify performance claims which shall be further examined or confirmed; c) specify and document the evaluation plan and the test procedures; d) prepare the evaluation report. The manufacturer shall ap
41、point a co-ordinator with overall responsibility of the performance evaluation study. The co-ordinator shall himself assure that adequate resources are available. The investigator shall ensure that the evaluation plan is followed at his location and that the study is appropriately reviewed from an e
42、thical point of view. 3.2 Documentation The documentation of the performance evaluation study shall contain the files relating to clauses 3 to 7 of this standard and shall be part of the technical documentation of the IVD MD. 3.3 Final assessment and review The co-ordinator shall assess and document
43、 which performance claims are met, state whether claims are not met and give recommendations for corrective actions, where necessary. The responsible management of the manufacturer shall make sure that the results of the performance evaluation study and the recommendations for corrective actions are
44、 carefully considered and properly documented before issuing a declaration of conformity. 4 Organisation of a performance evaluation study 4.1 Preconditions Before starting a performance evaluation study it shall be ensured by the co-ordinator that a) the performance claims of the IVD MD which are t
45、he subject of the study are specified; b) the IVD MD has been manufactured under controlled production processes and conditions; c) the IVD MD to be evaluated meets the quality control release specifications; d) a sufficient number of samples of the IVD MD can be provided during the entire period of
46、 the performance evaluation study; e) all legal requirements for performance evaluation studies are met; f) the investigator(s) is (are) adequately skilled and trained to conduct the study and the necessary resources are available. 4.2 Evaluation plan The evaluation plan shall state the purpose on s
47、cientific, technical or medical grounds, the scope of the evaluation, the structure and organization of the study and the number of devices concerned. Defining the objective of the study, the co-ordinator shall have assessed which performance claims are already verified by data or scientific literat
48、ure.EN 13612:2002 (E) 8 The evaluation plan shall be designed to minimise the requirements for invasive sampling. In the case of IVD MDs for self-testing it shall be ensured that the evaluation plan is appropriate and acceptable to users and the information provided shall be clear and easily underst
49、ood. The evaluation plan shall specify a) that the investigator(s) is (are) adequately skilled and trained to use the IVD MD; b) the list of laboratories or other institutions taking part in the performance evaluation study; for self- testing, the location and number of lay persons involved; c) the time-table; d) the necessary minimum number of probands from whom specimens are collected by invasive procedures in order to adequately assess the performance of the IVD MD; e) instructions for use including
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