EN ISO TS 20836-2005 en Microbiology of food and animal feeding stuffs - Polymerase chain reaction (PCR) for the detection of food-borne pathogens - Performance testing for thermal.pdf

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1、DRAFT FOR DEVELOPMENTDD CEN ISO/TS 20836:2005Microbiology of food and animal feeding stuffs Polymerase chain reaction (PCR) for the detection of food-borne pathogens Performance testing for thermal cyclersICS 07.100.30g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g5

2、4g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58DD CEN ISO/TS 20836:2005This Draft for Development was published under the authority of the Standards Policy and Strategy Committee on 31 August 2006 BSI 2006ISBN 0 580 47121 7Nation

3、al forewordThis Draft for Development is the official English language version of CEN ISO/TS 20836:2005.This publication is not to be regarded as a British Standard.It is being issued in the Draft for Development series of publications and is of a provisional nature because ISO/TS 20836 is a provisi

4、onal document. It should be applied on this provisional basis, so that information and experience of its practical application may be obtained.Comments arising from the use of this Draft for Development are requested so that UK experience can be reported to the European organization responsible for

5、its conversion to a European standard. A review of this publication will be initiated 2 years after its publication by the European organization so that a decision can be taken on its status at the end of its 3-year life. Notification of the start of the review period will be made in an announcement

6、 in the appropriate issue of Update Standards.According to the replies received by the end of the review period, the responsible BSI Committee will decide whether to support the conversion into a European Standard, to extend the life of the Technical Specification or to withdraw it. Comments should

7、be sent in writing to the Secretary of BSI Technical Committee AW/9, Microbiology, at British Standards House, 389 Chiswick High Road, London W4 4AL, giving the document reference and clause number and proposing, where possible, an appropriate revision of the text.A list of organizations represented

8、 on this subcommittee can be obtained 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 Catalogue under the section entitled “International Standards Correspondence Index”, or

9、by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Summary of pagesThis document comprises a front cover, an inside fr

10、ont cover, the CEN ISO/TS title page, the CEN ISO/TS foreword page, the ISO/TS title page, pages ii to v, a blank page, pages 1 to 13 and a back cover.The BSI copyright notice displayed in this document indicates when the document was last issued.Amendments issued since publicationAmd. No. Date Comm

11、entsTECHNICAL SPECIFICATIONSPCIFICATION TECHNIQUETECHNISCHE SPEZIFIKATIONCEN ISO/TS 20836August 2005ICS 07.100.30English VersionMicrobiology of food and animal feeding stuffs - Polymerasechain reaction (PCR) for the detection of food-borne pathogens -Performance testing for thermal cyclers (ISO/TS 2

12、0836:2005)Microbiologie des aliments - Raction de polymrisation enchane (PCR) pour la recherche des micro-organismespathognes dans les aliments - Critres de performancepour les thermal cyclers (ISO/TS 20836:2005)Mikrobiologie von Lebensmitteln und Futtermitteln -Polymerase Kettenreaktion (PCR) zum N

13、achweis vonpathogenen Mikroorganismen in Lebensmitteln -Leistungsprfung fr PCR-Gerte (ISO/TS 20836:2005)This Technical Specification (CEN/TS) was approved by CEN on 28 September 2004 for provisional application.The period of validity of this CEN/TS is limited initially to three years. After two year

14、s the members of CEN will be requested to submit theircomments, particularly on the question whether the CEN/TS can be converted into a European Standard.CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS availablepromptly at nationa

15、l level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS)until the final decision about the possible conversion of the CEN/TS into an EN is reached.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Rep

16、ublic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATI

17、ONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2005 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. CEN ISO/TS 20836:2005: EForeword This document (CEN ISO/TS 20836:2005) has been prepared by Tech

18、nical Committee CEN/TC 275 “Food analysis - Horizontal methods“, the secretariat of which is held by DIN, in collaboration with Technical Committee ISO/TC 34 “Agricultural food products“. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countri

19、es are bound to announce this CEN Technical Specification: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, S

20、witzerland and United Kingdom. CEN ISO/TS 20836:2005Reference numberISO/TS 20836:2005(E)ISO 2005TECHNICAL SPECIFICATION ISO/TS20836First edition2005-08-01Microbiology of food and animal feeding stuffs Polymerase chain reaction (PCR) for the detection of food-borne pathogens Performance testing for t

21、hermal cyclers Microbiologie des aliments Raction de polymrisation en chane (PCR) pour la recherche des micro-organismes pathognes dans les aliments Critres de performance pour les thermal cyclers CEN ISO/TS 20836:2005ii iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references

22、. 1 3 Terms and definitions. 1 4 Installation of thermal cyclers . 2 5 Maintenance of thermal cyclers 2 6 Performance tests. 2 6.1 General. 2 6.2 Biochemical performance test 2 6.3 Physical performance test . 2 7 Test report and documentation of irregularities . 3 Annex A (informative) Biochemical p

23、erformance test PCR method for testing the temperature accuracy 4 Annex B (informative) Physical performance test 11 Bibliography . 13 CEN ISO/TS 20836:2005iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies).

24、 The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-

25、governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part

26、2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a

27、 vote. In other circumstances, particularly when there is an urgent market requirement for such documents, a technical committee may decide to publish other types of normative document: an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in an ISO work

28、ing group and is accepted for publication if it is approved by more than 50 % of the members of the parent committee casting a vote; an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical committee and is accepted for publication if it is approved by 2/3 o

29、f the members of the committee casting a vote. An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed, it is reviewed again after a

30、further three years, at which time it must either be transformed into an International Standard or be withdrawn. ISO/TS 20836 was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 275, Food analysis Horizontal methods, in collaboration with Technical Committee I

31、SO/TC 34, Food products, Subcommittee SC 9, Microbiology, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). CEN ISO/TS 20836:2005vIntroduction This Technical Specification is part of a series of International Standards under the general title Microbiol

32、ogy of food and animal feeding stuffs Polymerase chain reaction (PCR) for the detection of food-borne pathogens: General requirements and definitions (ISO 22174); Requirements for sample preparation for qualitative detection (ISO 20837); Performance testing for thermal cyclers (ISO/TS 20836); Requir

33、ements for amplification and detection for qualitative methods (ISO 20838). The International Organization for Standardization (ISO) draws attention to the fact that it is claimed that compliance with this document may involve the use of one or more patents concerning the PCR technology. ISO takes n

34、o position concerning the evidence, validity and scope of these patent rights. ISO has been informed that Applied Biosystems, Roche Molecular Systems, Inc. and F. Hoffman-La Roche Ltd. hold patent rights concerning the PCR technology. The companies have assured the ISO that they are willing to negot

35、iate licences under reasonable and non-discriminatory terms and conditions with applicants throughout the world. In this respect, the statements of the holders of these patent rights are registered with ISO. Information may be obtained from: Licensing Department Applied Biosystems 850 Lincoln Centre

36、 Drive Foster City, CA 94404 USA and Roche Molecular Systems, Inc. Licensing Department 1145 Atlantic Avenue Alameda, CA 94501 USA Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights other than those identified above. ISO shall not be

37、held responsible for identifying any or all such patent rights. CEN ISO/TS 20836:2005blank1Microbiology of food and animal feeding stuffs Polymerase chain reaction (PCR) for the detection of food-borne pathogens Performance testing of thermal cyclers WARNING The use of this Technical Specification m

38、ay involve hazardous materials, operations and equipment. This Technical Specification does not purport to address all of the safety problems associated with its use. It is the responsibility of the user of this Technical Specification to establish appropriate safety and health practices and to dete

39、rmine the applicability of regulatory limitations prior to use. 1 Scope This Technical Specification provides basic requirements for the installation, performance and maintenance of thermal cyclers. Although thermal cyclers are robust technical equipment, they do require regular maintenance. Their c

40、ooling/heating elements, either Peltier or other technology, have a limited lifetime. Proper functioning of the cooling/heating element depends both on the quality of the cooling/heating devices and proper use and care. In addition to outlining the requirement for a defined maintenance programme, pr

41、ocedures are described for the determination of thermal cycler performance by biochemical or physical methods (see Annexes A and B). 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies.

42、 For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 22174, Microbiology of food and animal feeding stuffs Polymerase chain reaction (PCR) for the detection of food-borne pathogens General requirements and definitions ISO/IEC 17025, General r

43、equirements for the competence of testing and calibration laboratories 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 22174 and the following apply. 3.1 heated lid optional feature of a thermal cycler used to prevent evaporation from the reaction tu

44、be 3.2 temperature uniformity homogeneity of the temperature within the thermally controlled unit (e.g. heating block) 3.3 biochemical performance test test procedure which determines the performance of a thermal cycler by biochemical means (e.g. a temperature-sensitive PCR) CEN ISO/TS 20836:20052 3

45、.4 physical performance test test procedure which determines the performance of a thermal cycler by physical means 3.5 non-robust PCR system PCR system in which minor deviations from the prescribed PCR chemistry or PCR temperature protocol result in a less efficient amplification 3.6 critical positi

46、on position or area where a deviation of the sample temperature from the displayed temperature is more likely to occur than in other areas of the thermal cycler sample holder 4 Installation of thermal cyclers The manufacturers instructions should be followed. The following should be taken into consi

47、deration: a) thermal cyclers should be installed and run at an appropriate temperature and humidity; b) thermal cyclers should be located so they can be inspected visually, in such a way as to allow a steady exchange of heat with the environment and free circulation of air, and in a constant environ

48、ment. 5 Maintenance of thermal cyclers The laboratory should establish and employ a defined maintenance programme for each thermal cycler machine, based on the documented hours of use or number of runs. 6 Performance tests 6.1 General The performance testing of each thermal cycler should be carried

49、out and documented, either indirectly using a biochemical performance test or directly using a physical performance test. 6.2 Biochemical performance test A biochemical procedure for thermal cycler performance testing should be carried out, which may be a temperature-sensitive non-robust PCR method. An example of a suitable method is described in Annex A. Any other PCR methods that can be shown to fulfil the requirements may also be used. The performance test frequency should be based on the documented hours of use or the nu