1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12306:1998 The Euro
2、pean Standard EN 12306 : 1997 has the status of a British Standard ICS 07.080; 07.100.99 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Biotechnology Guidance for quality control of diagnostic kits used in agriculture, plant and animal pest and disease control and environment
3、al contaminationThis British Standard, having been prepared under the direction of the Sector Board for Materials and Chemicals, was published under the authority of the Standards Board and comes into effect on 15 March 1998 BSI 1998 ISBN 0 580 29260 6 BS EN 12306:1998 Amendments issued since public
4、ation Amd. No. Date Text affected National foreword This British Standard is the English language version of EN 12306:1997. The UK participation in its preparation was entrusted to Technical Committee CII/58, Biotechnology, which has the responsibility to: aid enquirers to understand the text; prese
5、nt to the responsible international/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
6、 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 section entitled “International Standards Correspondence Index”, or by using the “Fi
7、nd” 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 lega
8、l obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 5 and a back cover.CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-10
9、50 Brussels 1997 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 12306 : 1997 E EUROPEAN STANDARD EN 12306 NORME EUROPE ENNE EUROPA ISCHE NORM October 1997 ICS 07.080; 07.100.99 Descriptors: Biotechnology, agriculture, animals, spe
10、cies (botany), hazards, diseases, contamination, micro-organisms, noxious micro-organisms, environmental protection, accident prevention, quality control, diagnosis, in-vitro diagnosis English version Biotechnology Guidance for quality control of diagnostic kits used in agriculture, plant and animal
11、 pest and disease control and environmental contamination Biotechnologie Guide pour le contro le de qualite des trousses de diagnostic utilise es en agriculture pour la surveillance des maladies et des agents nuisibles pour les plantes et les animaux et des contaminations environnementales Biotechni
12、k Leitfaden zur Qualita tsu berwachung von Diagnostikpackungen zur Verwendung in der Landwirtschaft, bei der Scha dlingsbeka mpfung, Beka mpfung von Krankheiten bei Pflanzen und Tieren sowie bei Kontaminationen der Umwelt This European Standard was approved by CEN on 21 August 1997. CEN members are
13、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 on application to th
14、e Central 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 stat
15、us 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, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.Page 2 EN 12306:1997 BSI 1998 F
16、oreword This European Standard has been prepared by Technical Committee CEN/TC 233, Biotechnology, the secretariat of which is held by AFNOR. 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 April
17、1998, and conflicting national standards shall be withdrawn at the latest by April 1998. 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). According to the
18、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, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Swe
19、den, Switzerland and the United Kingdom. Contents Page Foreword 2 Introduction 3 1 Scope 3 2 Normative references 3 3 Definitions 3 4 General considerations 4 5 Quality control procedures 4 Annex A (informative) Bibliography 5Page 3 EN 12306:1997 BSI 1998 Introduction Diagnostic kits are manufacture
20、d as multicomponent products designed for the qualitative or quantitative detection of a target organism or substance. Because the diagnostic kit includes more than one component (e.g. reagents, materials, accessories) it is important to assess the performance of the whole system. In this European S
21、tandard it is assumed that diagnostic kits are a homogeneous category of products, even though each assay procedure may be affected by specific experimental parameters. 1 Scope This European Standard provides guidance for a quality control procedure of a diagnostic kit to assure that the assay resul
22、ts will fulfil the intended purpose of the test by both manufacturers and users. This European Standard applies to diagnostic kits used in agriculture, plant and animal pest and disease control monitoring of feed and environmental contamination due to micro-organisms. This standard does not apply to
23、 diagnostic kits used either in the food industry or for human health monitoring, or control of non-biological contaminants. This European Standard does not concern single kit components such as reagents (i.e. monoclonal or polyclonal antibodies) or materials (i.e. ELISA plate). This standard does n
24、ot concern any specific diagnostic method (such as ELISA, Dot blot, DNA probe). This European Standard does not aim to establish a system of quality assurance but it is recommended that quality control procedures are in accordance with a system of quality assurance such as EN ISO 9000 series. 2 Norm
25、ative references 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
26、 any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. EN 375, In vitro diagnostic systems Requirements for labelling of in vitro diagnostic reagents for profe
27、ssional use EN 1619, Biotechnology Large-scale process and production General requirements for management and organization for strain conservation procedures 3 Definitions For the purposes of this standard, the following definitions apply. 3.1 accuracy closeness of agreement between a test result an
28、d the accepted reference value NOTE 1 The term accuracy, when applied to a set of test results, involves a combination of random components and a common systematic error or bias component ISO 3534-1. NOTE 2 Accuracy of a diagnostic test is the probability of finding exact results. 3.2 diagnostic kit
29、 set of kit components and instructions for use packaged together and intended for in vitro measurement or detection of a specified analyte 3.3 kit component reagent or another material intended to be part of a diagnostic kit 3.4 micro-organism any microbiological entity, cellular or non-cellular, c
30、apable of replication or of transferring genetic material EN 1619 NOTE For the purposes of this standard, the term micro-organism covers the term of biological agent, according to the Directive 90/679/EEC: micro-organisms, including those which have been genetically modified, cell cultures and human
31、 endoparasites which may be able to provoke any infection, allergy or toxicity. 3.5 precision closeness of agreement between independent test results obtained under stipulated conditions NOTE 1 Precision depends only on the distribution of random errors and does not relate to the true value or the s
32、pecified value. NOTE 2 The measure of precision usually is expressed in terms of imprecision and computed as a standard deviation of the test results. Less precision is reflected by a larger standard deviation. NOTE 3 “Independent test results” means results obtained in a manner not influenced by an
33、y previous result on the same or similar test object. Quantitative measures of precision depend critically on the stipulated conditions. Repeatability and reproducibility conditions are particular sets of extreme stipulated conditions. ISO 3534-1Page 4 EN 12306:1997 BSI 1998 3.6 sensitivity capacity
34、 to record small variation in concentration of a substance in the test material NOTE Sensitivity of a diagnostic test is the probability of detecting a target organism (positive response) in an infected or contaminated test material. 3.7 specificity capacity to specifically recognize the analyte to
35、be detected, distinguishing it from similar substances, impurities or degradation products NOTE Specificity of a diagnostic test is the probability not to detect a target organism (negative response) in a non-infected or non-contaminated test material. 4 General considerations The manufacturer of th
36、e diagnostic kit should implement a quality control procedure designed to: attest the performance characteristics of the diagnostic kit; achieve the performance characteristics by preventing misuse of the diagnostic kit; ensure the suitability for the intended purpose; ensure consistency with the ne
37、ed for protection of human health, animal and environment safety; ensure the performance characteristics are not affected by storage and transportation conditions. Assessment of quality of a diagnostic kit is based on the reliability of the assay results. Diagnostic results may be considered reliabl
38、e when the specific performance characteristics stated by the manufacturer, are achieved. Relevant parameters for performance characteristics may be sensitivity, specificity, precision or accuracy. These performance characteristics should be determined through appropriate tests already known from th
39、e state-of-the-art for each kind of assay. The achievement of stated performances depends on the following: the sampling procedure; the availability and commutability of control material; the method of expressing the results. 5 Quality control procedures 5.1 Assay performance The manufacturer and th
40、e user should implement quality control procedures designed to assure the achievement of the stated performance characteristics by referring to a control material or, if available, a certified reference material. Control material should be made available by the manufacturer, preferably as a kit comp
41、onent. The nature of the control material should be defined. The traceability of values assigned to control material should be assured by the kit manufacturer through available certified reference materials and reference measurement procedures appropriate to actual assay conditions. In this regard,
42、the manufacturer should assist the user by providing information about the source of control material. NOTE Examples of control materials are a plant extract, an animal serum which specifically reacts with a known pathogen isolate, a purified compound or a virus of a known concentration. Control mat
43、erials are processed according to the instructions for use of the diagnostic kit in the same fashion as any test material. The results obtained, either qualitative or quantitative, are compared with the expected values indicated in the instructions. Correspondence with these results, and also with v
44、alues generally agreed in the literature indicates the reliability of the results. 5.2 Packaging, labelling and instructions for use The packaging of the diagnostic kit should include the kit components and the instructions for their use in accordance with EN 375. Labels should be placed on the oute
45、r container in which the kit components are packaged, as well as on the immediate container in which each component is contained. NOTE Since a diagnostic kit can contain kit components which are chemical substances, attention is drawn to European and national regulations (see annex A 4). a) The labe
46、l on the outer container should state: product name; name and address of the manufacturer; intended use; number of tests that can be performed; storage information; lot number; expiry date; danger or other symbols and warning, where appropriate. b) The label on the immediate container should state:
47、product name; name of the manufacturer; name and amount of the kit component; intended use; storage information; lot number; expiry date; danger or other symbols and warning, where appropriate. c) The transport package label should remind those responsible for transportation the essential conditions
48、 required to assure safety, integrity and stability of the product, as well as, operator safety. Special regard should be given to range of allowed temperature variation.Page 5 EN 12306:1997 BSI 1998 d) The instructions for use should include: the product name; the principle of the assay; the sampli
49、ng procedure; the assay procedure; the claimed specific performance characteristics (such as sensitivity, specificity, precision or accuracy); the collection and interpretation of the results; the known limitations of the assay; the traceability to reference material, if available. Annex A (informative) Bibliography 1 Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms, OJEC 08.05.1990, no. L 117, p. 1. 2 Co
