1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationDD CEN ISO/TS 22117:2010Microbiology of food andanimal feeding stuffs Specific requirements andguidance for proficiencytesting by interlaboratorycomparison (ISO/TS22117:2010)DD C
2、EN ISO/TS 22117:2010 DRAFT FOR DEVELOPMENTNational forewordThis Draft for Development is the UK implementation of CEN ISO/TS22117:2010.This publication is not to be regarded as a British Standard.It is being issued in the Draft for Development series of publicationsand is of a provisional nature. It
3、 should be applied on thisprovisional basis, so that information and experience of its practicalapplication can be obtained.Comments arising from the use of this Draft for Developmentare requested so that UK experience can be reported to theinternational organization responsible for its conversion t
4、oan international standard. A review of this publication willbe initiated not later than 3 years after its publication by theinternational organization so that a decision can be taken on itsstatus. Notification of the start of the review period will be made inan announcement in the appropriate issue
5、 of Update Standards.According to the replies received by the end of the review period,the responsible BSI Committee will decide whether to support theconversion into an international Standard, to extend the life of theTechnical Specification or to withdraw it. Comments should be sentto the Secretar
6、y of the responsible BSI Technical Committee at BritishStandards House, 389 Chiswick High Road, London W4 4AL.The UK participation in its preparation was entrusted to TechnicalCommittee AW/9, Microbiology.A list of organizations represented on this committee can beobtained on request to its secretar
7、y.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2010ISBN 978 0 580 65688 0ICS 07.100.30Compliance with a British Standard cannot confer immunity fromlegal obligations.This Draft for Development was publis
8、hed under the authority ofthe Standards Policy and Strategy Committee on 30 November 2010.Amendments issued since publicationDate Text affectedTECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN ISO/TS 22117 November 2010 ICS 07.100.30 English Version Microbiology of food and
9、 animal feeding stuffs - Specific requirements and guidance for proficiency testing by interlaboratory comparison (ISO/TS 22117:2010) Microbiologie des aliments - Exigences spcifiques et lignes directrices pour les essais daptitude par comparaison interlaboratoires (ISO/TS 22117:2010) Mikrobiologie
10、von Lebensmitteln und Futtermitteln - Spezielle Anforderungen an die Eignungsprfung durch Ringversuche (ISO/TS 22117:2010) This Technical Specification (CEN/TS) was approved by CEN on 9 August 2010 for provisional application. The period of validity of this CEN/TS is limited initially to three years
11、. After two years the members of CEN will be requested to submit their comments, 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 available
12、promptly at national 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, Belgi
13、um, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMI
14、TTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. CEN ISO/TS 22117:2010: EDD CEN ISO/TS 221
15、17:2010CEN ISO/TS 22117:2010 (E) 3 Foreword This document (CEN ISO/TS 22117:2010) has been prepared by Technical Committee ISO/TC 34 “Food products“ in collaboration with Technical Committee CEN/TC 275 “Food analysis - Horizontal methods” the secretariat of which is held by DIN. Attention is drawn t
16、o the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following c
17、ountries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovak
18、ia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO/TS 22117:2010 has been approved by CEN as a CEN ISO/TS 22117:2010 without any modification. DD CEN ISO/TS 22117:2010ISO/TS 22117:2010(E) ISO 2010 All rights reserved iiiContents Page Foreword iv Intro
19、duction.v 1 Scope1 2 Normative references1 3 Terms and definitions .2 4 Scheme design and purpose .2 4.1 General .2 4.2 Scheme objectives 2 4.3 Laboratory requirements for schemes3 4.4 Choice of test matrices.3 4.5 Information on test methods used by the PT provider3 4.6 Statistical design.3 5 Techn
20、ical requirements and guidance for sample design and content 4 5.1 Target organisms level .4 5.2 Sources, characterization and traceability of organisms .4 5.3 Background and competitive flora 5 5.4 Matrix selection and effects .5 6 Sample verification by the provider 5 6.1 General .5 6.2 Sample hom
21、ogeneity testing General considerations5 6.3 Homogeneity testing for quantitative (enumeration) samples .6 6.4 Homogeneity testing for qualitative methods 7 6.5 Stability testing by the provider.7 7 Sample handling8 7.1 General .8 7.2 Instructions to participants 8 8 Performance evaluations9 8.1 Gen
22、eral .9 8.2 Preliminary considerations 9 8.3 Quantitative methods9 8.4 Assessment of qualitative methods16 Annex A (informative) Example of details to be included in a PT scheme plan.19 Annex B (informative) Methods of testing for variation between portions of test materials 21 Annex C (informative)
23、 A practical method to assess long-term performance of participants in PT schemes using enumeration methods24 Annex D (informative) Example of a safety data sheet .26 Bibliography28 DD CEN ISO/TS 22117:2010ISO/TS 22117:2010(E) iv ISO 2010 All rights reservedForeword ISO (the International Organizati
24、on for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). 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 ha
25、s the right to be represented on that committee. International organizations, governmental and non-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. Inte
26、rnational Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 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. Publica
27、tion as an International Standard requires approval by at least 75 % of the member bodies casting a 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 document: an ISO Publicly Available
28、 Specification (ISO/PAS) represents an agreement between technical experts in an ISO working group and is accepted for publication if it is approved by more than 50 % of the members of the parent committee casting a vote; ISO Technical Specification (ISO/TS) represents an agreement between the membe
29、rs of a technical committee and is accepted for publication if it is approved by 2/3 of 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 Standa
30、rd, or withdrawn. If the ISO/PAS or ISO/TS is confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an International Standard or be withdrawn. Attention is drawn to the possibility that some of the elements of this document may be the subject o
31、f patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO/TS 22117 was prepared by Technical Committee ISO/TC 34, Food products, Subcommittee SC 9, Microbiology. DD CEN ISO/TS 22117:2010ISO/TS 22117:2010(E) ISO 2010 All rights reserved vIntroduction Genera
32、l requirements for organization of proficiency testing (PT) schemes of all types are given through ISO/CASCO (Committee on Conformity Assessment) in ISO/IEC 17043; additionally, general guidance is available from the International Union of Pure and Applied Chemistry (IUPAC, see Reference 9) and the
33、International Laboratory Accreditation Cooperation (ILAC, see Reference 8). However, these recommendations may not be directly applicable to all cases and should be interpreted specifically for different laboratory sectors where PT schemes are organized. For this reason, a document is needed to esta
34、blish the criteria which a provider (and associated collaborators) of PT schemes shall meet in order to be recognized as competent to provide PT schemes for microbiological analysis. This applies particularly to the specific technical requirements necessary to deal with living microorganisms, such a
35、s sample homogeneity and stability, as well as with the interpretation of presence/absence (detection) tests which is not covered by an existing document. Proficiency testing schemes for microbiology laboratories are mainly used to evaluate performance, particularly trueness (bias) and in some cases
36、 precision, of food microbiological examinations in specific laboratories. Additionally, data from such PT schemes can be used: a) to provide information to the organizations responsible for laboratory acceptance within an official control framework and to allow continuous monitoring; b) to aid labo
37、ratory accreditation in a general framework of quality management; c) to inform those responsible for quality in the participating laboratories as part of the educative elements of external quality assessment of trueness (bias). Information from PT schemes may also be used for: 1) identification of
38、the possible sources of errors, particularly the bias component of uncertainty, to improve performance; 2) estimation of measurement uncertainty for enumeration methods (see ISO/TS 190366) and limits of detection for presence/absence methods; 3) demonstration of staff competence to perform a specifi
39、c microbiological examination; 4) evaluation or validation of a given method by the study of trueness and precision; 5) identification of variability between individual laboratories; 6) assignment of a “target” value for an analyte in a material in order to establish a reference material. However, t
40、hese aspects are not specifically covered in this Technical Specification. Proficiency testing schemes are therefore organized to meet certain criteria and the testing programme (frequency, number of samples, number of repeats, etc.) shall meet the requirements of the type of method used and commodi
41、ty analysed, to achieve the level of control desired by all parties involved. DD CEN ISO/TS 22117:2010DD CEN ISO/TS 22117:2010TECHNICAL SPECIFICATION ISO/TS 22117:2010(E) ISO 2010 All rights reserved 1Microbiology of food and animal feeding stuffs Specific requirements and guidance for proficiency t
42、esting by interlaboratory comparison 1 Scope This Technical Specification gives requirements and guidance for the organization of proficiency testing schemes for microbiological examinations of: a) food and beverages; b) animal feeding stuffs; c) food production environments and food handling; d) pr
43、imary production stages. This Technical Specification is also potentially applicable to the microbiological examination of water where water is either used in food production or is regarded as a food in national legislation. This Technical Specification relates to the technical organization and the
44、implementation of proficiency testing schemes, as well as the statistical treatment of the results of microbiological examinations. This Technical Specification is designed for use with ISO/IEC 17043 and ISO 13528, and deals only with areas where specific or additional details are necessary for prof
45、iciency testing schemes dealing with microbiological analyses for the areas specified in the first paragraph. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references
46、, the latest edition of the referenced document (including any amendments) applies. ISO 3534-1, Statistics Vocabulary and symbols Part 1: General statistical terms and terms used in probability ISO 3534-2, Statistics Vocabulary and symbols Part 2: Applied statistics ISO 5725-1, Accuracy (trueness an
47、d precision) of measurement methods and results Part 1: General principles and definitions ISO 5725-5, Accuracy (trueness and precision) of measurement methods and results Part 5: Alternative methods for the determination of the precision of a standard measurement method ISO 7218, Microbiology of fo
48、od and animal feeding stuffs General requirements and guidance for microbiological examinations ISO 13528, Statistical methods for use in proficiency testing by interlaboratory comparisons ISO/IEC 17043:2010, Conformity assessment General requirements for proficiency testing DD CEN ISO/TS 22117:2010
49、ISO/TS 22117:2010(E) 2 ISO 2010 All rights reserved3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 3534-1, ISO 3534-2, ISO 5725-1, ISO 13528, ISO/IEC 17043 and the following apply. NOTE 1 Some terms used in the text have different meanings in microbiology and statistics, e.g. homogeneity, heterogeneity, test, sample, distribution. The context clarifies whether the terms refer to microbiological test samples or datasets used for statistical analysis. NOTE 2 Some providers of profici
