BS EN 591-2001 专业用体外诊断仪器的使用说明.pdf
《BS EN 591-2001 专业用体外诊断仪器的使用说明.pdf》由会员分享,可在线阅读,更多相关《BS EN 591-2001 专业用体外诊断仪器的使用说明.pdf(14页珍藏版)》请在三一文库上搜索。
1、BRITISH STANDARD BS EN 591:2001 Instructions for use for in vitro diagnostic instruments for professional use The European Standard EN 591:2001 has the status of a British Standard ICS 11.040.55 BS EN 591:2001 This British Standard, having been prepared under the direction of the Health and Environm
2、ent Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 May 2001 BSI 05-2001 ISBN 0 580 37232 4 National foreword This British Standard is the official English language version of EN 591:2001. It supersedes BS EN 591:1995 which is withdrawn. The
3、 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 British Standards which implement int
4、ernational or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to in
5、clude all the necessary provisions of a contract. Users of British Standards are responsible for their 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 responsible European committe
6、e 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 page, pages 2 to 11 a
7、nd a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 591 March 2001 ICS 11.100Supersedes EN 591:1994 English version Instructions
8、for use for in vitro diagnostic instruments for professional use Notices dutilisation des instruments pour le diagnostic in vitro pour usage professionnel Gebrauchsanweisungen fr Gerte fr in-vitro- diagnostische Untersuchungen zum Gebrauch durch Fachpersonal This European Standard was approved by CE
9、N on 19 January 2001. 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 bibliographical references concerning such national standard
10、s 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 member into its own language and notified to the M
11、anagement Centre has the same status as the officia versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdo
12、m. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2001 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 591:2001 Page 2 EN 5
13、91:2001 BSI 05-2001 Foreword This European Standard 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 s
14、hall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2001, and conflicting national standards shall be withdrawn at the latest by September 2001. This European Standard supersedes EN 591:1994. This European Standard
15、 has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive(s). For relationship with EC Directive(s), see informative Annex ZA, which is an integral part of this standard. According to the CE
16、N/CENELEC Internal Regulations, 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, Netherlands, Norway, Portugal, Spain, Swede
17、n, Switzerland and the United Kingdom. Page 3 EN 591:2001 BSI 05-2001 1Scope This standard specifies the requirements for the contents of instructions for use for in vitro diagnostic instruments including apparatus, equipment, calibrators and control materials for professional use, hereafter called
18、IVD instruments. NOTE 1 Instructions for use are essential to enable the safe and proper operation of IVD instruments. NOTE 2 This standard can also be applied to accessories. This standard is not applicable to field repair instructions. 2Normative references This European Standard incorporates by d
19、ated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standar
20、d only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies (including amendments). ISO 1000, SI units and recommendations for the use of their multiples and of certain other units. 3Terms and definitions For the purposes
21、of this European Standard, the following terms and definitions apply. 3.1 calibrator substance, material or article intended by its manufacturer to be used to establish the measurement relationships of an in vitro diagnostic medical device EN 375 3.2 control material substance, material or article i
22、ntended by its manufacturer to be used to verify the performance characteristics of an in vitro diagnostic medical device EN 375 3.3 instructions for use information supplied by the manufacturer with an IVD instrument concerning the proper use and the safe and correct operation, maintenance and basi
23、c trouble-shooting of the IVD instrument 3.4 internal quality control operational techniques and activities at the point of use that are used to fulfil requirements for quality of services EN 375 NOTE Internal quality control comprises all steps of activity for production of results from collection
24、of sample and measurement of a measurable quantity to reporting of result of measurement. 3.5 in vitro diagnostic instrument (IVD instrument) in vitro diagnostic medical device which is an instrument, apparatus or equipment NOTE 1 For the definition of an in vitro diagnostic medical device see 4. NO
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- BS EN 591-2001 专业用体外诊断仪器的使用说明 591 2001 专业 体外 诊断 仪器 使用说明
链接地址:https://www.31doc.com/p-3647127.html