《BS EN 592-2002 Instructions for use for in vitro diagnostic instruments for self-testing.pdf》由会员分享，可在线阅读，更多相关《BS EN 592-2002 Instructions for use for in vitro diagnostic instruments for self-testing.pdf（7页珍藏版）》请在三一文库上搜索。
1、BRITISH STANDARD BS EN 592:2002 Instructions for use for in vitro diagnostic instruments for self-testing The European Standard EN 592:2002 has the status of a British Standard ICS 11.100 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Licensed Copy: AUB User, na, Thu Oct 11 1
2、7:04:10 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS EN 592:2002 This British Standard, having been prepared under the direction of the Health and Environment Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strategy Committee on 3 May 2002 BSI 3 M
3、ay 2002 ISBN 0 580 39652 5 National foreword This British Standard is the official English language version of EN 592:2002. It supersedes BS EN 592:1995 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/69, In vitro diagnostic systems, which has the
4、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 international or European publications referred to in this document may be found in the BSI Standards Catalogue under the secti
5、on entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application.
6、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 committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related internat
7、ional 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 10, an inside back cover and a back cover. The BSI copyright date displayed in this document indicates when the document was las
8、t issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: AUB User, na, Thu Oct 11 17:04:10 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 592 February 2002 ICS 11.100Supersedes EN 592:1994 English version Instructions for use
9、 for in vitro diagnostic instruments for self- testing Instructions dutilisation dinstruments pour le diagnostic in vitro pour usage comme auto-test Gebrauchsanweisungen fr Gerte fr in-vitro- diagnostische Untersuchungen zur Eigenanwendung This European Standard was approved by CEN on 20 December 20
10、01. 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 standards may be obtained
11、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 Management Centre h
12、as 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, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEA
13、N COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2002 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 592:2002 E Licensed Copy: AUB
14、User, na, Thu Oct 11 17:04:10 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 592:2002 (E) 2 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 Associa
15、tion (EDMA) has contributed to its preparation. 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 August 2002, and conflicting national standards shall be withdrawn at the latest by August 2002. Thi
16、s European Standard supersedes EN 592:1994. This European Standard 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(s). For relationship with EU Directive(s), see informative annex Z
17、A, which is an integral part of this standard. According to the CEN/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, Irela
18、nd, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. 1 Scope This European Standard specifies the requirements for the contents of instructions for use for in vitro diagnostic instruments including apparatus and equipment for self-testing wh
19、ich hereafter are called IVD instruments. NOTE 1 Instructions for use are essential to enable the safe and proper operation of IVD instruments by lay persons. NOTE 2 This standard can also be applied to accessories. This standard is not applicable to field repair instructions. 2 Normative references
20、 This European Standard incorporates by dated 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 p
21、ublications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest editions of the publication referred to applies (including amendments). ISO 1000, SI units and recommendations for the use of their multiples and of certain other unit
22、s. 3 Terms and definitions For the purposes of this European Standard, the following terms and definitions apply. 3.1 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 me
23、dical device, see 1. Licensed Copy: AUB User, na, Thu Oct 11 17:04:10 GMT+00:00 2007, Uncontrolled Copy, (c) BSI w w w . b z f x w . c o m EN 592:2002 (E) 3 NOTE 2 In some cases a particular IVD instrument, as defined for use in human medicine, may serve also in veterinary medicine. EN 591:2001 3.2
24、instructions for use information supplied by the manufacturer with an IVD instrument concerning the proper use and the safe and correct operation, maintenance and basic trouble-shooting of the IVD instrument EN 591:2001 3.3 lay person individual who does not have specific medical education EN 376:20
25、02 3.4 self-testing use in the home or similar environments by a lay person who will relate the result of the test to him- or herself EN 376:2002 3.5 specimen biological material which is obtained in order to detect or to measure one or more quantities EN 375:2001 4 Form and presentation of the inst
26、ructions for use The wording shall be readily understood. Consideration shall be given to the following aspects of presentation, where appropriate: a) overview of operating elements; b) flow and block diagrams; c) integration and arrangement of text/illustrations; d) graphic emphasis of warnings; e)
27、 examples; f) diagrams of procedural steps. 5 Requirements for the content of the instructions for use 5.1 General Instructions for use for IVD instruments shall contain the information given in 5.2 to 5.19. The information provided shall be easy to read and well-organized. The print shall be easily
28、 legible and terms simple and not unnecessarily technical or scientific. Symbols and illustrations shall be used wherever possible. A statement that the instructions for use are to be read carefully shall be made. Where appropriate, instructions for use shall include a table of contents and an index
29、. The language(s) used shall be (an) official Community language(s), legally acceptable in the country in which Licensed Copy: AUB User, na, Thu Oct 11 17:04:10 GMT+00:00 2007, Uncontrolled Copy, (c) BSI w w w . b z f x w . c o m EN 592:2002 (E) 4 the IVD instrument is distributed; additional langua
30、ges are optional, bearing in mind the needs of the anticipated users. 5.2 Graphical symbols Any graphical symbols used on the IVD instrument shall be explained in the instructions for use. There are, however, certain well-understood symbols already in use which are recognised to be suitable without
31、need for further explanation, i. e. those symbols as so identified in EN 980. 5.3 Manufacturer The name and address of the manufacturer shall be given. NOTE The manufacturer is the entity which has taken the legal responsibility for the IVD instrument. The name and address of the authorized represen
32、tative shall also be given when this is a legal requirement. 5.4 Identification The name of the IVD instrument and/or separate instrument components shall be provided. 5.5 Storage and handling Instructions relevant to any particular storage and/or handling conditions shall be given. 5.6 Warnings and
33、 precautions Any warnings and precautions relevant to any special, unusual risks related to installation, operation, maintenance, transportation, storage or disposal of the IVD instrument shall be given. 5.7 Intended purpose The intended purpose of the IVD instrument and the fact that it is intended
34、 for self-testing shall be clearly stated. 5.8 Installation 5.8.1 General Where appropriate, instructions for setting up the IVD instrument shall be given. 5.8.2 Action upon delivery Where appropriate, information shall be provided on the following: a) unpacking; b) checking delivery for completenes
35、s; c) checking for damage during transport. Licensed Copy: AUB User, na, Thu Oct 11 17:04:10 GMT+00:00 2007, Uncontrolled Copy, (c) BSI w w w . b z f x w . c o m EN 592:2002 (E) 5 5.8.3 Preparation prior to installation Where appropriate, information shall be provided on the following: a) installati
36、on site requirements; b) technical prerequisites. 5.8.4 Bringing into operation Where appropriate, information shall be provided on the following: a) setting up; b) introduction, brief description; c) checks for proper installation. 5.9 Principles of measurement A short summary of the basic principl
37、es of measurement to enable a lay person to understand the used method shall be given. 5.10 Performance and limitations of use Information on the performance and limitations of use of the instrument and/or system shall be given. 5.11 Preparation prior to operation Where appropriate, information shal
38、l be provided on the following: a) any special materials and/or equipment required in order to use the IVD instrument properly; b) reagent(s); c) type of specimen to be used, any special conditions of collection and, if necessary, storage conditions; d) instrument checks and adjustment for safe and
39、correct operation. 5.12 Operating procedure 5.12.1 General A detailed description of the procedure to be followed (“how to carry out the test“) which can be clearly understood by a lay person shall be provided. If applicable, procedures for carrying out a control shall be given. Where appropriate, the operating procedure should be illustrated by a flow diagram. Licensed Copy: AUB User, na, Thu Oct 11 17:04:10 GMT+00:00 2007, Uncontrolled Copy, (c) BSI