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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 It supersedes BS EN 591:1995 which is withdrawn.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
25、TE 2 In some cases a particular IVD instrument, as defined for use in human medicine, may serve also in veterinary medicine. Page 4 EN 591:2001 BSI 05-2001 3.6 professional use use by personnel who have received special education and training with regard to procedures utilizing in vitro diagnostic m
26、edical devices EN 375 3.7 specimen biological material which is obtained in order to detect or to measure one or more quantities EN 375 4Form and presentation of the instructions for use The wording shall be readily understandable. The following shall be given, where appropriate: a) overview of oper
27、ating elements; b) flow and block diagrams of instrument construction; c) integration and arrangement of text/illustrations; d) graphic emphasis of warnings; e) examples; f) diagrams of procedural steps; g) relevant scientific literature. 5Requirements for the content of the instructions for use 5.1
28、General Instructions for use for IVD instruments shall contain the information given in 5.2 to 5.23. This information may be supplied in different ways, e. g. as user manual, part of the built-in software of the instrument, audio or video recording or other electronic means. Instructions for use sha
29、ll include a table of contents and an index. Languages shall be used in accordance with the requirements of the country(ies) in which the IVD instrument is distributed. 5.2Graphical symbols Any graphical symbols used on the IVD instrument shall be explained in the instructions for use, if no Europea
30、n or International Standards exist to which the symbols used conform. NOTE Any graphical symbols used on the IVD instrument should be explained and/or the relevant European or International Standards should be given. 5.3Manufacturer The name and address of the manufacturer shall be given. NOTE The m
31、anufacturer is the entity which has taken the legal responsibility for the IVD instrument. The name and address of the authorized representative shall also be given when this is a legal requirement. Page 5 EN 591:2001 BSI 05-2001 5.4Identification The name of the IVD instrument and/or separate instr
32、ument modules, including, where applicable, software shall be given. 5.5Storage and handling Instructions relevant to any particular storage and/or handling conditions shall be given. 5.6Warnings and precautions Any warnings and precautions shall be given relevant to: a) any special, unusual risks r
33、elated to installation, operation, maintenance, transportation, storage or disposal of the IVD instrument; NOTE Examples of such risks are those related to handling and disposal of infectious or potentially infectious materials. b) known interferences; c) use not recommended by the manufacturer. 5.7
34、Intended purpose The intended purpose of the IVD instrument shall be clearly stated. 5.8Installation 5.8.1General Instructions for setting up the IVD instrument shall be given when the installation can be carried out by the user. NOTE These instructions are not necessary when the installation is car
35、ried out exclusively by personnel from the manufacturer or a service organization. 5.8.2Action upon delivery Information shall be provided on the following: a) unpacking; b) checking delivery for completeness; c) checking for damage during transport. 5.8.3Preparation prior to installation Informatio
36、n shall be provided on the following: a) installation site requirements; b) technical prerequisites, e. g. load bearing capacity. Page 6 EN 591:2001 BSI 05-2001 5.8.4Bringing into operation Information shall be provided on the following: a) setting up; b) introduction, brief description; c) checks f
37、or proper installation. 5.9Theory Basic theory of the instrument operation shall be given. If any particular training of the user is required this shall be indicated. 5.10Functions Information shall be provided on the following: a) description, purpose; b) principles of working; c) operation; d) spe
38、cifications; e) automatic checks on the system; f) specific performance checks. 5.11Performance and limitations of use Information shall be provided on the following: a) general statements; b) performance characteristics of the IVD instrument, e. g. precision, throughput. 5.12Preparation prior to op
39、eration 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 special conditions of collection, pre-treatment and, if necessary, storage conditions; d) instrum
40、ent checks for correct and safe operation; e) adjustment. Page 7 EN 591:2001 BSI 05-2001 5.13Operating procedure A detailed description of the procedure to be followed which can be clearly understood by the user of the IVD instrument shall be provided. This shall include the principle of the method
41、as well as all phases of the operation from start up to reading of result(s). 5.14Presentation of analytical data A description of the mathematical approach used for calculation of the analytical result shall be given. This shall be easily understandable for users of the IVD instrument and shall hel
42、p them to interpret the analytical results. When possible, results shall be expressed in units according to ISO 1000. 5.15Special functions Information shall be provided on special functions where applicable. EXAMPLES: special function and performance checks; specimen identification; data output, no
43、tation, storage, security and transfer; special settings other than the normal mode of operation; interface protocol. 5.16Shut-down procedure Information shall be provided on the following: a) placing on stand-by; b) switching off; c) taking out of operation. 5.17Emergency procedure Operating proced
44、ure for emergency specimens shall be provided where applicable. 5.18Internal quality control Information shall be provided on the following: a) checking the function of the IVD instrument; b) verification of results; c) internal quality control of the entire in vitro diagnostic system. 5.19Disposal
45、information Where appropriate, information shall be provided on the safe disposal of waste materials (e. g. consumables, used reagents or reagent products including those mixed with specimens, instruments or components thereof). Page 8 EN 591:2001 BSI 05-2001 5.20Maintenance Information shall be pro
46、vided on the following: a) preventive maintenance (nature and frequency); b) cleaning instructions; c) sterilization, decontamination or disinfection; d) components list, including relevant working materials, tools; e) consumables; f) servicing; g) list of recommended spare parts. 5.21Trouble-shooti
47、ng Information shall be provided on the following: a) messages, error signals; b) establishing cause(s) of error(s); c) correction and elimination of error by the user; d) errors necessitating service calls; e) measures to be taken in the event of a change of the analytical performance of the IVD in
48、strument. 5.22 Technical specifications Information shall be supplied on the following: a) if appropriate, limitations on physical environment required for function according to manufacturers specifications, e. g. humidity, temperature, vibration, magnetic fields, external electrical influences, ele
49、ctrostatic discharge, pressure, acceleration, thermal ignition sources; b) dimensions, mass; c) basic settings made by the manufacturer; d) physical data, e. g. voltage, water pressure; e) consumption values in units according to ISO 1000, e. g. electrical power, water; f) if appropriate, electromagnetic emission and immunity. 5.23Date of issue or revision The date of issue or latest revision of the instructions for use shall be given. 6Requirements for supplementary information