CEN TS 17174-2018 Animal feeding stuffs Methods of sampling and analysis - Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Animal feeding stuffs: Methods of sampling and analysis - Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of heavy metalsPD CEN/TS 17174:2018TECHNI

2、CAL SPECIFICATION SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN/TS 17174 August 2018 ICS 65.120 English Version Animal feeding stuffs: Methods of sampling and analysis - Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of h

3、eavy metals Aliments des animaux : Mthodes dchantillonnage et danalyse - Critres de performance pour les mthodes danalyse valides par un ou plusieurs laboratoires pour le dosage des mtaux lourds Futtermittel - Probenahme- und Untersuchungsverfahren - Leistungskriterien fr laborintern validierte und

4、Ringversuch validierte Analysemethoden zur Bestimmung von Schwermetallen This Technical Specification (CEN/TS) was approved by CEN on 8 February 2018 for provisional application. The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be req

5、uested 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 promptly at national level in an appropriate for

6、m. 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, Bulgaria, Croatia, Cyprus, Czech Republic, D

7、enmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEA

8、N COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. CEN/TS 17174:2018

9、ENational forewordThis Published Document is the UK implementation of CEN/TS 17174:2018.The UK participation in its preparation was entrusted to Technical Committee AW/10, Animal feeding stuffs.A list of organizations represented on this committee can be obtained on request to its secretary.This pub

10、lication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 94201 3ICS 65.120Compliance with a British Standard cannot confer immunity

11、from legal obligations.This Published Document was published under the authority of the Standards Policy and Strategy Committee on 31 August 2018.Amendments/corrigenda issued since publicationDate Text affectedPUBLISHED DOCUMENTPD CEN/TS 17174:2018TECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE TECHN

12、ISCHE SPEZIFIKATION CEN/TS 17174 August 2018 ICS 65.120 English Version Animal feeding stuffs: Methods of sampling and analysis - Performance criteria for single laboratory validated and ring-trial validated methods of analysis for the determination of heavy metals Aliments des animaux : Mthodes dch

13、antillonnage et danalyse - Critres de performance pour les mthodes danalyse valides par un ou plusieurs laboratoires pour le dosage des mtaux lourds Futtermittel - Probenahme- und Untersuchungsverfahren - Leistungskriterien fr laborintern validierte und Ringversuch validierte Analysemethoden zur Bes

14、timmung von Schwermetallen This Technical Specification (CEN/TS) was approved by CEN on 8 February 2018 for provisional application. The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their comments, particularly

15、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 promptly at national level in an appropriate form. It is permissible to keep conflicting natio

16、nal 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, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Repu

17、blic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN

18、DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. CEN/TS 17174:2018 EPD CEN/TS 17174:2018CEN/TS 17174:2018 (E) 2 C

19、ontents Page European foreword . 3 Introduction 4 1 Scope 5 2 Normative references 5 3 Terms and definitions . 5 4 Criteria for analytical methods for heavy metals . 13 4.1 Overall concepts . 13 4.2 Horwitz/Thompson equation 13 4.3 Horwitz ratio 14 4.4 Precision 14 4.5 Trueness 15 4.6 Minimum applic

20、ability range 15 4.7 Limit of detection (LOD) and limit of quantification (LOQ) 16 Annex A (normative) Review of the repeatability and reproducibility relative standard deviations reported in the EN 15510 standard and EN 15621 technical specifications 17 Annex B (informative) Rrecand RSD versus mass

21、 fractions 21 Annex C (informative) Assessment of method compliance 23 Bibliography . 25 PD CEN/TS 17174:2018CEN/TS 17174:2018 (E) 3 European foreword This document (CEN/TS 17174:2018) has been prepared by Technical Committee CEN/TC 327 “Animal feeding stuffs: Methods of sampling and analysis”, the

22、secretariat of which is held by NEN. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CEN by

23、the European Commission and the European Free Trade Association. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark

24、, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom PD CEN/TS

25、17174:2018CEN/TS 17174:2018 (E) 4 Introduction The working group, CEN/TC 327 “Animal feeding stuffs - Methods of sampling and analysis” WG 4 “Elements and their chemical species” selects and elaborates methods of analysis of elements and their chemical species in feedstuffs. There are many methods o

26、f analysis for the determination of elements in feedstuffs, which have been validated and published. It is often required to make a choice between several established methods applicable to the same measurand (analyte/matrix combination). The Working Group was mandated by the European Commission 1 to

27、 establish specific criteria to guide the analyst in the selection between several methods of analysis. As a general rule, analysts should give preference to methods of analysis which comply with the provisions given in Clauses 1 and 2 of Annex III to the Regulation (EU) 2017/625 2, in the Directive

28、 2002/32/EC 3, with the Commission Regulation (EC) No 152/2009 4, or with the General Principles for Methods of Analysis of the Codex Alimentarius Commission (CAC), as defined in the CAC Procedural Manual 5 and further developed in the “criteria approach” to the methods of analysis developed by the

29、Codex Committee of Methods of Analysis and Sampling (CCMAS) 6. The performance criteria laid down in this document are based on published guidance documents (such as the AOAC guidelines 7; the IUPAC Harmonized Protocol 8 and the SANCO document 9) or data collected from official reports on European c

30、ollaborative studies (e.g. EN 15510 10 or EN 15621 11). When such performance characteristics are not available, the criteria were established based on the experience and opinions of the CEN/TC 327/WG 4. The criteria included in this document have also been used as guidance in the Working Group for

31、the selection of specific methods of analysis of trace elements to be further standardized, for the evaluation of on-going collaborative trials and for the review of previously published standards of analytical methods. NOTE All the criteria provided in this document refer to concentrations (mass fr

32、actions) greater than or equal to 0,1 mg/kg, related to the lowest maximum level (ML) set for mercury in feed. PD CEN/TS 17174:2018CEN/TS 17174:2018 (E) 5 1 Scope This document specifies performance criteria for the selection of single-laboratory validated or collaborative-trial validated methods of

33、 analysis of elements and their chemical species in feed. The terms and definition of the relevant parameters for method validation are included. The performance requirements and characteristics are provided. This document may serve as a guide: to assess the quality of new European Standard methods

34、under validation; to review the quality of previous collaborative trials; to confirm the extension of the scope of an already published European Standard applied to other analyte concentrations or matrices; or to evaluate the fitness-for-purpose of single-validated methods. The performance criteria

35、can apply to methods dedicated to the determination of heavy metals, trace elements, major elements and minerals. 2 Normative references There are no normative references in this document. 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 accur

36、acy closeness of agreement between a test result and the accepted reference value SOURCE: ISO 5725-1, see 12 Note 1 to entry: 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. Note 2 to entry: It is

37、assessed by determining trueness and precision. SOURCE: 2002/657/EEC, see 13 3.2 applicability scope of the analytical method; description of the analytes, matrices, and concentration ranges (mass fractions) for which a method of analysis may be used satisfactorily to determine compliance with a giv

38、en standard (i.e. CEN, ISO, CODEX) Note 1 to entry: In addition to a statement of the range of capability of satisfactory performance for each factor, the statement of applicability (scope) also includes warnings as to known interference by other analytes, or inapplicability to certain matrices and

39、situations. 3.3 bias difference between the expectation of the test results (x) and an accepted reference value (xref) SOURCE: ISO 5725-1, see 12 PD CEN/TS 17174:2018CEN/TS 17174:2018 (E) 6 Note 1 to entry: The bias can be expressed in absolute or relative terms (b or b(%), respectively) as: ref= bx

40、x (1) refref= 100(%)xxbx(2) SOURCE: Eurachem 2014, see 14 3.4 inter-laboratory comparison organisation, performance and evaluation of measurements or tests on the same or similar items by two or more laboratories in accordance with predetermined conditions SOURCE: ISO/IEC 17043:2010, see 15 Note 1 t

41、o entry: The larger the number of participating laboratories, the greater the confidence that can be placed in the resulting statistical parameters. 3.4.1 collaborative trials inter-laboratory comparison aiming at the evaluation of the performance characteristics of a method often described as ring-

42、test or ring-trial SOURCE: ISO/IEC 17043:2010, see 15 Note 1 to entry: It means analysing the same sample by the same method to determine the performance characteristics of the method. Note 2 to entry: The study covers random measurement error and laboratory bias. SOURCE: 2002/657/EEC, see 13 Note 3

43、 to entry: The reported results are used to estimate the performance characteristics of the method, such as precision. When necessary and possible, other pertinent characteristics such as systematic error and/or recovery may be reported. 3.4.2 proficiency testing inter-laboratory comparison aiming a

44、t the evaluation of participant performance against pre-established criteria SOURCE: ISO/IEC 17043:2010, see 15 Note 1 to entry: The reported results are compared with those from other laboratories or with the known or assigned reference value, usually with the objective of evaluating or improving l

45、aboratory performance. Note 2 to entry: Proficiency testing means analysing the same sample allowing laboratories to choose their own methods, provided these methods are used under routine conditions. SOURCE: 2002/657/EEC, see 13 PD CEN/TS 17174:2018CEN/TS 17174:2018 (E) 7 3.4.3 reference material c

46、haracterisation inter-laboratory comparison aiming at the assignment of values to reference materials and assessment of their suitability for use in specific test or measurement procedures SOURCE: ISO/IEC 17043:2010, see 15 3.5 limit of detection xLODconcentration (mass fraction) derived from the sm

47、allest measure that can be detected with reasonable certainty for a given analytical procedure SOURCE: ISO 11843, see 16 Note 1 to entry: For analytical systems where the validation range does not include or approach it, the detection limit does not need to be part of a validation. SOURCE: IUPAC 200

48、2, see 8 Note 2 to entry: The various conceptual approaches to the subject depend on the estimate of precision at or near zero concentration (mass fraction) under repeatability or reproducibility conditions. 3.6 limit of quantification xLOQlowest concentration (mass fraction) determined with satisfa

49、ctory measurement uncertainty SOURCE: ISO 11843, see 16 Note 1 to entry: It is useful to state a concentration (mass fraction) below which the analytical method cannot operate with an acceptable precision. Such precision is arbitrarily defined as relative standard deviation of 10 %. Note 2 to entry: Usually the limit is set as a fixed multiple (e.g. 3,3) of the detection limit. Note 3 to entry: Measurements below LOQ are not devoid of information content and are fit for