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1、BRITISH STANDARD BS EN 592:1995 Specification for User manuals for in vitro diagnostic instruments for home use The European Standard EN 592:1994 has the status of a British Standard UDC 616-07:579.61:658.62.04.11 Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:37 GMT+00:00 2006, Uncont
2、rolled Copy, (c) BSI BS EN 592:1995 This British Standard, having been prepared under the direction of the Health Care Standards Policy Committee, was published under the authority of the Standards Board and comes into effect on 15 January 1995 BSI 09-1999 The following BSI references relate to the
3、work on this standard: Committee reference HCC/69 Draft for comment 93/57328 DC ISBN 0 580 23124 0 Cooperating organizations The European Committee for Standardization (CEN), under whose supervision this European Standard was prepared, comprises the national standards organizations of the following
4、countries: AustriaOesterreichisches Normungsinstitut BelgiumInstitut belge de normalisation DenmarkDansk Standard FinlandSuomen Standardisoimisliito, r.y. FranceAssociation franaise de normalisation GermanyDeutsches Institut fr Normung e.V. GreeceHellenic Organization for Standardization IcelandTech
5、nological Institute of Iceland IrelandNational Standards Authority of Ireland ItalyEnte Nazionale Italiano di Unificazione LuxembourgInspection du Travail et des Mines NetherlandsNederlands Normalisatie-instituut NorwayNorges Standardiseringsforbund PortugalInstituto Portugus da Qualidade SpainAsoci
6、acin Espaola de Normalizacin y Certificacin SwedenStandardiseringskommissionen i Sverige SwitzerlandAssociation suisse de normalisation United KingdomBritish Standards Institution Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:37
7、 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 592:1995 BSI 09-1999i Contents Page Cooperating organizationsInside front cover National forewordii Foreword2 1Scope3 2Definitions3 3Form and presentation of the user manual3 4Content of the user manual3 5Supplementary information5 Annex A (informati
8、ve) Bibliography6 National annex NA (informative) Committees responsibleInside back cover National annex NB (informative) Cross-referencesInside back cover Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:37 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 592:1995 ii BSI 09-1999 Nationa
9、l foreword This British Standard has been prepared under the direction of the Health Care Standards Policy Committee and is the English language version of EN 592:1994 In vitro diagnostic systems Requirements for user manuals for in vitro diagnostic instruments for home use, published by the Europea
10、n Committee for Standardization (CEN). EN 592 was produced as a result of international discussions in which the United Kingdom took an active part. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct
11、 application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN title page, pages 2 to 6, an inside back cover and a back cover. This standard has been up
12、dated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:37 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM E
13、N 592 September 1994 UDC 616-07:579.61:658.62.04.11 Descriptors: Medicine, diagnosis, medical equipment, utilization, handbooks, specifications English version In vitro diagnostic sytems Requirements for user manuals for in vitro diagnostic instruments for home use Systmes danalyses mdicales in vitr
14、o Rgles pour les manuels dutilisation dinstruments pour le diagnostic in vitro pour usage domicile In-vitro-Diagnostik/Diagnostika Anforderungen an Benutzerhandbcher fr In-vitro-Diagnostika-Gerte zum Gebrauch zu Hause This European Standard was approved by CEN on 1994-09-06. CEN members are bound to
15、 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 on application to the Centra
16、l Secretariat 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 Central Secretariat has the same status as th
17、e official versions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europ
18、en de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1994 Copyright reserved to CEN members Ref. No. EN 592:1994 E Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:37 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 592:1994 BSI 09-1999
19、 2 Foreword This European Standard has been prepared by the Technical Committee CEN/TC 140, In vitro diagnostic systems, the Secretariat of which is held by DIN. Annexes designated “informative” are given only for information. In this standard Annex A is informative. This European Standard shall be
20、given the status of a National Standard, either by publication of an identical text or by endorsement, at the latest by March 1995, and conflicting national standards shall be withdrawn at the latest by March 1995. According to the CEN/CENELEC Internal Regulations, the following countries are bound
21、to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:37 GMT+00:00 2006, Uncontroll
22、ed Copy, (c) BSI EN 592:1994 BSI 09-19993 1 Scope This standard specifies the content of user manuals for in vitro diagnostic instruments for home use. NOTEUser manuals are essential to enable the safe and proper operation of instruments by trained and untrained personnel. This standard is not appli
23、cable to field repair instructions. 2 Definitions For the purposes of this standard, the following definitions apply. 2.1 calibration1) the set of operations that establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values
24、 represented by a material measure or a reference material, and the corresponding values of a measurable quantity realized by a measurement standard 2.2 calibrator1) reference material used for calibration 2.3 in vitro diagnostic instrument1) any instrument which, used alone or in combination with o
25、ther in vitro diagnostic medical devices, is intended by the manufacturer wholly or mainly to be used in vitro for the examination of substances derived from the human body for the purpose of providing information relevant to the detection, diagnosis, monitoring or treatment of physiological states,
26、 states of health or disease, or congenital abnormality NOTEA given in vitro diagnostic instrument, as defined for use in human medicine, in some cases may serve also in veterinary medicine. 2.4 in vitro diagnostic system1) any measuring system which is intended by the manufacturer wholly or mainly
27、to be used in vitro for the examination of substances derived from the human body for the purpose of providing information relevant to the detection, diagnosis, monitoring or treatment of physiological states, states of health or disease, or congenital abnormality NOTEA given in vitro diagnostic sys
28、tem, as derived for use in human medicine, in some cases may serve also in veterinary medicine. 2.5 manufacturer1) the natural or legal person with responsibility for the design, manufacture, packaging and labelling or a device before it is placed on the market under his own name, regardless of whet
29、her these operations are carried out by that person himself or on his behalf by a third party 2.6 manufacturing1) the complete process of production from the acquisition of all materials through all processing stages and including final packaging 2.7 specimen1) biological material which is obtained
30、in order to detect or to measure one or several quantities 2.8 user manual1) document accompanying an instrument containing information for the safe and correct operation, maintenance and basic trouble-shooting of the instrument 3 Form and presentation of the user manual The wording should be readil
31、y understood. Consideration should be given to the following aspects of presentation: a) naming of operating elements (overview); b) flow and block diagrams; c) integration and arrangement of text/illustrations; d) graphic emphasis of warnings; e) examples; f) diagrams of essential manipulations. 4
32、Content of the user manual 4.1 General User manuals for in vitro diagnostic instruments shall contain the information given in 4.2 to 4.13. The language(s) of the country in which the product is distributed shall be used. NOTEMultilingual user manuals are recommended. 4.2 Identification The followin
33、g information shall be provided: a) name of the instrument and/or instrument modules; 1) Provisional statement, subject to revision depending upon future EC Directives and/or European Standards. Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:37 GMT+00:00 2006, Uncontrolled Copy, (c) BS
34、I EN 592:1994 4 BSI 09-1999 b) name of manufacturer; c) date of issue or revision; d) table of contents, index. 4.3 Precautionary measures and warnings Any warnings shall be given in the appropriate sections of the user manual relevant to: a) possible hazards during installation, operation, maintena
35、nce, transportation and storage; b) interferences and actions not recommended by the manufacturer. 4.4 Symbols An explanation of symbols used on the instrument shall be given. 4.5 Installation 4.5.1 General Instructions for setting up the instrument shall be given. 4.5.2 Action upon delivery Informa
36、tion shall be provided on the following: a) storage; b) unpacking; c) checking delivery for completeness; d) checking for damage during transport. 4.5.3 Preparation prior to installation Information shall be provided on the following: a) installation site requirements; b) technical prerequisites. 4.
37、5.4 Bringing into operation Information shall be provided on the following: a) set up; b) introduction, brief description; c) checks. 4.6 Checks Information shall be provided on the following: a) automatic checks on the system; b) specific performance checks. 4.7 Theory A short summary of basic theo
38、ry as far as necessary for comprehension of the instrument operation by the lay user shall be given. 4.8 Performance criteria and limitations Information shall be provided on the following: a) general statements; b) reliability of the instrument and the limitation of use. NOTEThis information should
39、 be expressed and presented in laymans terms. 4.9 Operating procedure 4.9.1 General Where appropriate, operating procedures shall be augmented by: a) line drawings; b) photographs. NOTEIt is strongly recommended that the operating procedure should be easy to understand. 4.9.2 Operation Information s
40、hall be provided on the following: a) switching on; b) placing on stand-by; c) switching off; d) taking out of operation. 4.9.3 Performance check Information shall be provided on the following: a) controls; b) checking the instrument; c) some form of simple performance checks of the entire system. 4
41、.9.4 Special functions Information shall be provided on special functions where applicable. NOTEExamples include information on the following: a) specimen identification; b) data output, notation, storage, security and transfer. 4.9.5 Disposal instructions Where appropriate, information shall be pro
42、vided on the disposal of materials. NOTEExamples include disposal of the following items: a) consumables; b) reagents including mixtures with specimens; c) instruments or components thereof. 4.10 Maintenance Simple maintenance instructions shall be provided on the following: a) preventive maintenanc
43、e; b) cleaning instructions; c) disinfection, sterilization; d) components list, including relevant working materials, tools; e) consumables. 4.11 Trouble-shooting Information shall be provided on the following: a) messages, error signals; b) error searching; c) correction and elimination or error b
44、y the user; Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:37 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 592:1994 BSI 09-19995 d) error necessitating service calls. 4.12 Follow-up action Specific information as to follow-up action shall be given. NOTEFor example “Consult your physic
45、ian”. 4.13 Technical specifications Information shall be provided on the following: a) physical environment (e.g. humidity, temperature); b) dimensions, mass; c) basic settings made by the manufacturer; d) physical data (e.g. voltage); e) consumption values (e.g. electrical power, water). 5 Suppleme
46、ntary information 5.1 General If appropriate, user manuals for in vitro diagnostic instruments shall provide the supplementary information given in 5.2 to 5.7. 5.2 List of uses and applications Information shall be provided on the following: a) index of methods; b) reagents; c) method sheets. 5.3 Wa
47、rranty limitations A statement of specific warranty limitations shall be provided, e.g. action by users which may invalidate the manufacturers warranty. 5.4 Ordering information Information shall be provided on the following: a) list of spare parts and consumables; b) relevant addresses. 5.5 Possibi
48、lities of extension Information shall be provided on the following: a) interface description; b) modules. 5.6 Assistance Information shall be provided on the following: a) training; b) service request protocol; c) list of offices and sources of service (mailing addresses, telephone numbers, telephon
49、e trouble-shooting); d) logbook. 5.7 Performance information A statement shall be given that the manufacturer will provide on request information on the instrument, e.g. sensitivity and specificity, accuracy and reproductibility. Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:37 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 592:1994 6 BSI 09-1999 Annex A (informative) Bibliography EN 61010-1, Safety requirements for electrical equipment for measurement, control and laboratory use Part 1: General requirements (IEC 1010-1:1990 +