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1、国内外标准大全豆丁网国内外标准下载地址 http:/ STANDARD BS EN592:2002Instructions for use for in vitro diagnostic instruments forself-testingThe European Standard EN 592:2002 has the status of aBritish StandardICS 11.100NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 592:2002National forewor
2、dThis 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 It supersedes BS EN 592:1995 which is withdrawn.The UK participation in its preparation was entrusted to Technical CommitteeCH/69, In vitro diagnostic systems, which has the responsibility to:aid enquirers to understand
3、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 international and European developments and promulgate them in the UK.A list of organizations represented on this committee can be o
4、btained on request to its secretary.Cross-referencesThe British Standards which implement international 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”
5、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.Compliance with a British Standard does not of itself confer immunity from legal obli
6、gations.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 on3 May 2002 BSI 3 May 2002ISBN 0 580 39652 5Summary of pagesThis document comp
7、rises 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 last issued.Amd. No.DateCommentsAmendments issued since publicationEUROPEAN STANDARD NORME EUROPENNEEUR
8、OPISCHE NORMEN 592February 2002ICS 11.100Supersedes EN 592:1994English versionInstructions for use for in vitro diagnostic instruments for self- testingInstructions dutilisation dinstruments pour le diagnostic in vitro pour usage comme auto-testGebrauchsanweisungen fr Gerte fr in-vitro- diagnostisch
9、e Untersuchungen zur EigenanwendungThis European Standard was approved by CEN on 20 December 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
10、-date lists and bibliographical 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
11、 responsibility of a CEN member 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,
12、Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATION C O M I T EUR O P EN DE NOR M A L I S A TI ON EUR O P I S C H ES KOM I TEE F R NOR M U NG Management Centre: rue de Stassart, 36 B-1050 Brussels 2002 CENAll rights of exploitati
13、on in any form and by any means reserved worldwide for CEN national Members.Ref. No. EN 592:2002 EEN 592:2002 (E)ForewordThis 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 Man
14、ufacturers Association (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
15、 August 2002.This 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 infor
16、mative annex ZA, which is an integral part of this standard. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark,Finland, France, Germany, Greece, Ic
17、eland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.1 ScopeThis European Standard specifies the requirements for the contents of instructions for use for in vitro diagnostic instruments including apparatus and equipment for self-
18、testing which 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 ref
19、erencesThis 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 t
20、hese publications 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
21、 units.3 Terms and definitionsFor the purposes of this European Standard, the following terms and definitions apply.3.1in vitro diagnostic instrumentIVD instrumentin vitro diagnostic medical device which is an instrument, apparatus or equipmentNOTE 1 For the definition of an in vitro diagnostic medi
22、cal device, see 1.5NOTE 2 In some cases a particular IVD instrument, as defined for use in human medicine, may serve also in veterinary medicine.EN 591:20013.2instructions for useinformation supplied by the manufacturer with an IVD instrument concerning the proper use and the safe andcorrect operati
23、on, maintenance and basic trouble-shooting of the IVD instrument EN 591:20013.3lay personindividual who does not have specific medical education EN 376:20023.4self-testinguse in the home or similar environments by a lay person who will relate the result of the test to him- or herselfEN 376:20023.5 s
24、pecimenbiological material which is obtained in order to detect or to measure one or more quantities EN 375:20014 Form and presentation of the instructions for useThe wording shall be readily understood. Consideration shall be given to the following aspects of presentation, where appropriate:a) over
25、view of operating elements;b) flow and block diagrams;c) integration and arrangement of text/illustrations;d) graphic emphasis of warnings;e) examples;f) diagrams of procedural steps.5 Requirements for the content of the instructions for use5.1 GeneralInstructions for use for IVD instruments shall c
26、ontain 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 legible and terms simple and not unnecessarily technical or scientific. Symbols and illustrations shall be used wherever possible. A statement that the instructio
27、ns for use are to be read carefully shall be made.Where appropriate, instructions for use shall include a table of contents and an index.The language(s) used shall be (an) official Community language(s), legally acceptable in the country in whichthe IVD instrument is distributed; additional language
28、s are optional, bearing in mind the needs of the anticipated users.5.2 Graphical symbolsAny 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 need
29、 for further explanation, i. e. those symbols as so identified in EN 980.5.3 ManufacturerThe 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 representative s
30、hall also be given when this is a legal requirement.5.4 IdentificationThe name of the IVD instrument and/or separate instrument components shall be provided.5.5 Storage and handlingInstructions relevant to any particular storage and/or handling conditions shall be given.5.6 Warnings and precautionsA
31、ny 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 purposeThe intended purpose of the IVD instrument and the fact that it is intended for self-testin
32、g shall be clearly stated.5.8 Installation5.8.1 GeneralWhere appropriate, instructions for setting up the IVD instrument shall be given.5.8.2 Action upon deliveryWhere appropriate, information shall be provided on the following:a) unpacking;b) checking delivery for completeness;c) checking for damag
33、e during transport.5.8.3 Preparation prior to installationWhere appropriate, information shall be provided on the following:a) installation site requirements;b) technical prerequisites.5.8.4 Bringing into operationWhere appropriate, information shall be provided on the following:a) setting up;b) int
34、roduction, brief description;c) checks for proper installation.5.9 Principles of measurementA short summary of the basic principles of measurement to enable a lay person to understand the used method shall be given.5.10 Performance and limitations of useInformation on the performance and limitations
35、 of use of the instrument and/or system shall be given.5.11 Preparation prior to operationWhere appropriate, information shall 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
36、 special conditions of collection and, if necessary, storage conditions;d) instrument checks and adjustment for safe and correct operation.5.12 Operating procedure5.12.1 GeneralA 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.