EN 13612-2002 en Performance evaluation of in vitro diagnostic medical devices (Incorporating Corrigendum December 2002)《在实验室条件下诊断医疗装置的性能评估 合并勘误表-2002年12月》.pdf
《EN 13612-2002 en Performance evaluation of in vitro diagnostic medical devices (Incorporating Corrigendum December 2002)《在实验室条件下诊断医疗装置的性能评估 合并勘误表-2002年12月》.pdf》由会员分享,可在线阅读,更多相关《EN 13612-2002 en Performance evaluation of in vitro diagnostic medical devices (Incorporating Corrigendum December 2002)《在实验室条件下诊断医疗装置的性能评估 合并勘误表-2002年12月》.pdf(18页珍藏版)》请在麦多课文档分享上搜索。
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
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