EN 15842:2010

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Živila - Odkrivanje prisotnosti alergenov v živilih - Splošne ugotovitve in validacija metodLebensmittel - Nachweis von Lebensmittelallergenen - Allgemeine Betrachtungen und Validierung von VerfahrenProduits alimentaires - Détection des allergènes alimentaires - Considérations générales et validation des méthodesFoodstuffs - Detection of food allergens - General considerations and validation of methods67.050Splošne preskusne in analizne metode za živilske proizvodeGeneral methods of tests and analysis for food productsICS:Ta slovenski standard je istoveten z:EN 15842:2010SIST EN 15842:2010en,fr,de01-maj-2010SIST EN 15842:2010SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 15842
February 2010 ICS 67.050 English Version
Foodstuffs - Detection of food allergens - General considerations and validation of methods
Produits alimentaires - Détection des allergènes alimentaires - Considérations générales et validation des méthodes
Lebensmittel - Nachweis von Lebensmittelallergenen - Allgemeine Betrachtungen und Validierung von VerfahrenThis European Standard was approved by CEN on 25 December 2009.
CEN members are 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 the CEN Management Centre 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 CEN Management Centre has the same status as the official versions.
CEN members are the national standards bodies of 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, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
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B-1000 Brussels © 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 15842:2010: ESIST EN 15842:2010

(ISO/IEC 17025:2005) EN ISO 17511:2003, In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators and control materials
(ISO 17511:2003) ISO Guide 31, Reference materials — Contents of certificates and labels ISO Guide 35, Reference materials — General and statistical principles for certification 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 accepted reference value value that serves as an agreed-upon reference for comparison and which is derived as:  theoretical or established value, based on scientific principles,  an assigned value, based on experimental work of some national or international organization,  consensus value, based on collaborative experimental work under the auspices of a scientific or engineering group [ISO Guide 30:1992] 3.2 accuracy closeness of agreement between a test result or measurement result and the true value SIST EN 15842:2010

NOTE 1 Bias is the total systematic error as contrasted to random error. There may be one or more systematic error components contributing to the bias. A larger systematic difference from the accepted reference value is reflected by a larger bias value. NOTE 2 The bias of a measuring instrument is normally estimated by averaging the error of indication over an appropriate number of repeated measurements. The error of indication is the "indication of a measuring instrument minus a true value of the corresponding input quantity". [ISO 3534-2:2006] 3.5 Certified Reference Material
CRM reference material, accompanied by a certificate, one or more of whose property values are certified by a procedure which establishes its traceability to an accurate realisation of the unit in which the property values are expressed, and for which each certified value is accompanied by an uncertainty at a stated level of confidence [ISO Guide 30:1992]
3.6 certified value for a CRM, value that appears in the certificate accompanying the material [ISO Guide 30:1992] 3.7 characterization for a reference material, determination of one or more physical, chemical, biological, or technological property values that are relevant to its intended end use
[ISO Guide 30:1992] 3.8 collaborative study interlaboratory study
interlaboratory study in which each laboratory uses a defined method of analysis to analyse identical portions of homogenous material to assess the performance characteristics obtained for the method of analysis
degree to which data produced by a measurement process enables a user to make technically and administratively correct decisions for a stated purpose NOTE See [17]. 3.12 homogeneity condition of being of uniform structure or composition with respect to one or more specified properties
NOTE A reference material is said to be homogeneous with respect to a specified property if the property value, as determined by tests on samples of specified size, is found to lie within the specified uncertainty limits, the samples being taken either from different supply units (bottles, packages, etc.) or from a single supply unit. [Adapted from ISO Guide 30:1992] 3.13 laboratory sample sample as prepared for sending to the laboratory and intended for inspection or testing [ISO 78-2:1999]
3.14 limit of detection
LOD
minimum amount or concentration of the analyte in test sample which can be detected reliably but not necessarily quantified, as demonstrated by a collaborative trial or other appropriate validation 3.15
limit of detection for quantitative determinations
amount of an analyte corresponding to the lowest measurement signal which with a closely defined confidence may be interpreted as indicating that the analyte is present in the sample, but without allowing exact quantification 3.16 limit of detection for qualitative determinations threshold concentration below which positive identification is unreliable according to the established requirements for reliability SIST EN 15842:2010

LOQ
lowest concentration or amount of the analyte in a test sample which can be quantitatively determined with an acceptable level of precision and accuracy, as demonstrated by collaborative trail or other appropriate validation NOTE See [24]. 3.18 limit of quantification limit of determination lowest amount of an analyte which can be determined quantitatively with a closely defined confidence NOTE See [24]. 3.19 linearity ability to elicit test results that are directly, or by means of well defined, mathematical transformations, proportional to the concentration of analyte in samples within a given range NOTE See [15]. 3.20 matrix all compounds in the sample with the analyte NOTE Each matrix has generally a common name which permits classification. [EN ISO 21572:2004] 3.21 outlier member of a set of values which is inconsistent with the other members of that set NOTE ISO 5725 specifies the statistical tests and the significance level used to identify outliers in trueness and precision experiments. [ISO 5725-1:1994]
3.22 practicability
ease of operations, in terms of sample throughput and costs, to achieve the required performance criteria and thereby meet the specified purpose [EN ISO 24276:2006] 3.23 precision closeness of agreement between independent test/measurement 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 specified value.
NOTE 2 The measure of precision is usually expressed in terms of imprecision and computed as standard deviation of the test results or measurements results. Less precision is reflected by a larger standard deviation.
Quantitative measures of precision depend critically on the stipulated conditions. Repeatability conditions and reproducibility conditions are particular sets of extreme stipulated conditions.
[ISO 3534-2:2006] 3.24 primary standard standard that is designated or widely acknowledged as having the highest metrological qualities and whose value is accepted without reference to other standards of the same quantity, within a specified context [ISO Guide 30:1992] 3.25 recovery proportion of the amount of analyte, present in or added to the analytical portion of the test material, which is extracted and presented for measurement NOTE See [18]. 3.26 reference material material or substance one or more of whose property values are sufficiently homogeneous and well established to be used for the calibration of an apparatus, the assessment of a measurement method, or for assigning values to materials [ISO Guide 30:1992] 3.27 reference method thoroughly investigated method, clearly and exactly describing the necessary conditions and procedures, for the measurement of one or more property values that has been shown to have accuracy and precision commensurate with its intended use and that can therefore be used to assess the accuracy of other methods for the same measurement, particularly in permitting the characterisation of a reference material
[ISO Guide 30:1992] 3.28 repeatability
precision under repeatability conditions NOTE Repeatability can be expressed quantitatively in terms of the dispersion characteristics of the results. [ISO 3534-2:2006]
3.29 repeatability conditions
observation conditions where independent test/measurement results are obtained with the same method on identical test/measurement items in the same test or measuring facility by the same operator using the same equipment within short intervals of time NOTE Repeatability conditions include:  same measurement procedure or test procedure;  same operator;  same measuring or test equipment used under the same conditions;  same location; SIST EN 15842:2010

r repeatability critical difference for a specified probability of 95 % [ISO 3534-2:2006] 3.31 repeatability standard deviation standard deviation of test results or measurement results obtained under repeatability conditions NOTE 1 It is a measure of the dispersion of the distribution of test or measurement results under repeatability conditions.
NOTE 2 Similarly "repeatability variance" and "repeatability coefficient of variation" can be defined and used as measures of the dispersion of test or measurement results under repeatability conditions. [ISO 3534-2:2006] 3.32 reproducibility
precision under reproducibility conditions NOTE 1 Reproducibility can be expressed qualitatively in terms of the dispersion characteristics of the results. NOTE 2 Results are usually understood to be corrected results. [ISO 3534-2:2006]
3.33 reproducibility conditions
observation conditions where independent test/measurement results are obtained with the same method on identical test/measurement items in different test or measurement facilities by different operators using different equipment [ISO 3534-2:2006]
3.34 reproducibility limit
reproducibility critical difference for a specified probability of 95 % [ISO 3534-2:2006] 3.35 reproducibility standard deviation
standard deviation of test results or measurement results obtained under reproducibility conditions NOTE 1 It is a measure of the dispersion of the distribution of test or measurement results under reproducibility conditi
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