1、STD.BSI BS EN L230b-ENGL 1998 lb24bb9 Ob89877 9bL BRITISH STANDARD Biotechnology - Guidance for quality control of diagnostic kits used in agriculture, plant and animal pest and disease control and environmental contamination The European Standard EN 12306 : 1997 has the status of a British Standard
2、 ICs 07.080 07.100.99 BS EN 12306:1998 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW STD-BSI BS EN 1230b-ENGL L998 D LbZLibbS Ob89878 8T8 Amd. No. BS EN 123W1998 Date Text affected This British Standard, having been prepared under the direction of the Sector Board for Materi
3、als and Chemicals, was published under the authority of the Standards Board and comes into effect on 15 March 1998 O BSI 1998 ISBN O 580 29260 6 National foreword This British Standmi is the English language version of EN 12306 1997. The UK participation in its preparation was entrusted to Technical
4、 Committee CIy58, Biotechnology, which has the responsibility to: - aid enquirers to understand the text; - present to the responsible internationallEuropean committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; - monitor related international an
5、d European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement inkrnational or European publications referred to in this document may be found in the BSI
6、Standards Catalogue under the section entitled “Intemationai 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 conimct Users of British Standards are responsible
7、 for their correct 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 nont cover, the EN title page, pages 2 to 5 and a back cover. Amendments issued since publication STD.BS1 BS
8、 EN L230b-ENGL 1778 = 1b2gbbS b87877 73LI W EUROPEAN sTANDAR;D NO- EUROPENNE EuR0PAzscHE Nom EN 12306 October 1997 ICs 07.080 07.100.99 Descriptors: Biotechnology, agriculture, animals, species (botany), hazards, diseases, contamination, micro-organisms, noxious micro-organisms, environmental protec
9、tion, accident prevention, quality control, diagnosis, in-vitro diagnosis English version Biotechnology - Guidance for qyahty control of dmgnostic kits used in agriculture, plant and animal pest and disease control and en.nmental contamhation Biotechnologie - Guide pour le contrle de Biotechnik - Le
10、itfaden zur qualit des trousses de dqqmtic utbes en Qualitsberwachung von agriculture pour la surveillance des maladies Diagnoshkpackungen zur Verwendung in der et des agents nuisibles pour les plantes et les IrindwirtschaR, bei der animaux et des contaminah OIIS Schadlingsbekampfung, Bekmpfung von
11、environnemenales Krankheiten bei Wanzen und Tieren sowie bei Kontaminationen der Umwelt This European Standard was approved by CEN on 21 August 1997. CEN members are bound to comply with the CENKENELEC Internai Regulations which stipuiate the conditions for giving this European Standard the status o
12、f a national standard without any alteration. Up-to-date lists and bibliographicai references concerning such national standards may be obtained on application to the Centsal Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). Aversio
13、n in any other language made by translation under the responsibiity of a CEN member into its own language and notified to the Central Secretariat has the same status as the officiai versions. CENmembers are the national standards bodies of Austri - ensure consistency with the need for protection of
14、human health, anima and environment safe, - ensure the performance charactetics are not anected by storage and transportation conditions. Assessment of quaJity of a diagnostic kit is based on the reliabiiy of the assay results. Diagnostic results may be considered reliable when the specific performa
15、nce characteristics stated by the manufacturer, are achieved Relevant parameters for performance characteristics may be sensitivity, specificity, precision or accuracy These performance charactwcs should be determined through appropriate tests already known from the state-of-the-art for each kind of
16、 assay The achievement of stated performances depends on the following: - the sampling procedure; - the avaiiability and commutability of control mate - the method of expressing the results. 5 Qdty control procedures 6.1 Assay performance The manufacturer and the user should implement quality contro
17、l procedures designed to assure the achievement of the stated performance characteristics by referring to a control material or, if available, a certified reference materid Control material should be made available by the manuhcturer, preferably as a kit component. The nature of the control material
18、 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, the manufacturer should assist the user b
19、y providing information about the source of control material. NOTE Examples of control materiais 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 materiais are processed according to the ins
20、tsuctions for use of the diagnostic kit in the me fashion as any test materiai. The results obtained, either tative or quantitative, are compared with the expected values indicated in the instructions. Correspondence with these results, and also with values generally agreed in the literature indicat
21、es the reiiability of the results. 6.2 Packaging, labelling and instructions for use The packagmg 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 outer container in which the kit components are packa
22、ged, 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 label on the outer container should state: - product
23、 name; - name and address of the manufactureq - 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: - product name; - name of the muf
24、acturer; - 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 required to assure
25、 safety, integrity and stability of the product, as well as, operator safety. Special regard should be given to range of allowed temperahre variation. 0 BSI 1998 d) The jnstructions for use should include: - the product name; - the principle of the asax - the sampling procedure; - the assay procedur
26、e; - the claimed specific performance characteristics (such as sensitivity, specificity, precision or accuracy); - the collection and interpretation of the results; - the known imitations of the assay; - the h-aceablity to reference material, if available. Page 5 EN 123W1997 Annex A (informative) Bi
27、bliography Council Directive 90f219EEC of 23 Apri 1990 on the contained use of genetically modified microorganisms, OJEC 08.05.1990, no. L 117, p. 1. Council Directive 90/220/EEC of 23 Apri 1990 on the deliberate release into the environment of genetically modified organisms, OJEC 08.05.1990, no. L
28、117, p. 15. Council Directive 90/679EEC of 26 November 1990 on the protection of workers from risks related to exposure to biological agents at work (seventh individual Directive within the meaning of Article 16 of Directive 899VEEC), OJEC 31.12.1990, no. L 374, p. 1. Council Directive 6754UEEC of 2
29、7 June 1967 amended, on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Eloit, M. (1993). Mthodologie du dpzsfage des maladies infectieuses animales contugima, Unit Pdagogique Maladies Contagieu
30、ses, Ecole nationale vtrinaire francaise; fvrier 1993. Matthews R.E.F. (1993). Diagnosis of plant vim diseases, CRC Press Inc. msse I? (1985). Practice and thory of enzyme immunoassay, In-labora,tory techniques in biochemlstq a,nd molecular biology (Vol. 15), Ed R.H. Burdon and P. H. Van Knippenberg
31、 (Elsevier). IS0 3534-1, Statistics - Vocabulary a,nd symbols -Pa.? 1: Probability a,nd general statistical temzs EN IS0 9000-1, Quality manqement. and quality assurance standards Part 1: Guidelines for selection and use (IS0 9000-1: 1994) quality assurance in &sign, development, production, instali
32、ation and servicing (Is0 9001: 1994) EN IS0 9002, Quality systems - Model for qua.lity assurance in production, instahtion and servicing (IS0 9002: 1994) EN IS0 9003, Quality systems - Model for quality assarance in fiml inspection und test (IS0 9003: 1994) EN IS0 90041,Quality malnagement and quaii
33、ty system elements -Part 1: Ouaines (IS0 90041: 1994) EN IS0 9001, Quality systems - Model for O BSI 1998 STD-BSI BS EN L230b-ENGL 1998 9 LbZqbbS Ob898q OTL 9 BS EN 12306: 1998 BSI 389 Chiswick High Road London w4 4AL BSI - British Standards Institution BSI is the independent national body responsib
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