SIST EN 16101:2013
(Main)Water quality - Guidance standard on the design and analysis of interlaboratory comparison studies for ecological assessment
Water quality - Guidance standard on the design and analysis of interlaboratory comparison studies for ecological assessment
This European Standard provides guidance on interlaboratory comparison with a special focus on biological methods. Guidance on the methods and procedures given in this standard should ensure that field survey results and laboratory analyses are comparable within specified limits. This guidance enables participants in interlaboratory comparison to demonstrate their level of performance. In addition it provides a mechanism for quality improvement. This standard describes a general course of the procedure. Detailed elements can be found in EN 14996, EN ISO/IEC 17000, EN ISO/IEC 17025, and EN ISO/IEC 17043.
Wasserbeschaffenheit - Anleitung zur Planung und Auswertung von Laborvergleichuntersuchungen für ökologische Untersuchungen
Diese Europäische Norm gibt eine Anleitung zu einem Laborvergleichstest. Die in dieser Norm vorgelegte Anleitung zu Verfahren und Durchführungen sollte sicherstellen, dass Ergebnisse aus Freiland¬untersuchungen und Laboranalysen innerhalb festgelegter Grenzen vergleichbar sind. Diese Anleitung ermöglicht es den Teilnehmern eines Laborvergleichstests ihre Leistungsfähigkeit darzustellen. Zusätzlich liefert sie ein Regelwerk zur Qualitätsverbesserung. Diese Norm beschreibt eine Verfahrensstruktur. Detaillierte Ausführungen sind in EN 14996 und EN ISO/IEC 17025 zu finden.
Qualité de l'eau - Guide pour la conception et l'analyse des études comparatives interlaboratoires ayant pour objet l'évaluation écologique
La présente Norme européenne donne des lignes directrices sur la comparaison interlaboratoires, avec un intérêt particulier pour les méthodes biologiques. Il convient que les lignes directrices sur les méthodes et modes opératoires données dans la présente norme garantissent la comparabilité des résultats de l’étude sur le terrain et des analyses de laboratoire dans des limites définies. Ces lignes directrices permettent aux participants des comparaisons interlaboratoires de démontrer leur niveau de performance. En outre, elle propose un mécanisme d’amélioration de la qualité. La présente norme décrit une structure générale de processus. Le détail des éléments est disponible dans l’EN 14996, l’EN ISO/CEI 17000, l’EN ISO/CEI 17025 et l’EN ISO/CEI 17043.
Kakovost vode - Navodilo za načrtovanje in analizo medlaboratorijskih primerjalnih študij za ekološko oceno
Ta evropski standard podaja navodilo za medlaboratorijsko primerjavo s posebnim poudarkom na bioloških metodah. Navodilo za metode in postopke iz tega standarda naj bi zagotovilo primerljivost rezultatov terenskih raziskav in laboratorijskih analiz v določenih mejah. To navodilo udeležencem v medlaboratorijski primerjavi omogoča prikaz njihove ravni učinkovitosti. Poleg tega zagotavlja mehanizem za izboljšanje kakovosti. Ta standard opisuje splošen potek postopka. Podrobni elementi so opisani v standardih EN 14996, EN ISO/IEC 17000, EN ISO/IEC 17025 in EN ISO/IEC 17043.
General Information
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.VNLKWasserbeschaffenheit - Anleitung zur Planung und Auswertung von Laborvergleichuntersuchungen für ökologische UntersuchungenQualité de l'eau - Guide pour la conception et l'analyse des études comparatives interlaboratoires ayant pour objet l'évaluation écologiqueWater quality - Guidance standard on the design and analysis of interlaboratory comparison studies for ecological assessment13.060.45Preiskava vode na splošnoExamination of water in generalICS:Ta slovenski standard je istoveten z:EN 16101:2012SIST EN 16101:2013en,fr,de01-januar-2013SIST EN 16101:2013SLOVENSKI
STANDARD
SIST EN 16101:2013
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 16101
October 2012 ICS 13.060.45 English Version
Water quality - Guidance standard on interlaboratory comparison studies for ecological assessment
Qualité de l'eau - Guide pour les études comparatives interlaboratoires ayant pour objet l'évaluation écologique
Wasserbeschaffenheit - Anleitung für Vergleichsprüfungen zwischen Laboratorien für ökologische Untersuchungen This European Standard was approved by CEN on 25 August 2012.
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-CENELEC 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-CENELEC 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
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Avenue Marnix 17,
B-1000 Brussels © 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 16101:2012: ESIST EN 16101:2013
EN 16101:2012 (E) 2 Contents Page Foreword .3Introduction .41Scope .52Terms and definitions .53Principle .64Procedures .7Annex A (normative)
Approaches in interlaboratory comparison . 10Annex B (informative)
Statistical analysis . 12Annex C (informative)
Characteristics associated with measurement procedure in biological investigation methods . 15Bibliography . 17 SIST EN 16101:2013
EN 16101:2012 (E) 3 Foreword This document (EN 16101:2012) has been prepared by Technical Committee CEN/TC 230 “Water analysis”, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2013, and conflicting national standards shall be withdrawn at the latest by April 2013. Attention is drawn to 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 organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. SIST EN 16101:2013
EN 16101:2012 (E) 4 Introduction SAFETY PRECAUTIONS — Safety issues are paramount when surveying surface waters. Surveyors should conform to EU and national Health and Safety legislation and any additional guidelines appropriate for working in or near water. The importance of data quality in ecological results is explicit in highlighted in several EU Directives. For example the EC Water Framework Directive (WFD 2000/60/EC), Annex V, Clause 1.3.4. "Estimates of the confidence and precision attained by the monitoring system used shall be stated in the river basin monitoring plan." This means that ecological data from aquatic environments should be of a known and verifiable quality. This European dimension drives regulatory agencies, research bodies, universities and contractors working across Europe to become increasingly involved in ensuring that the data produced from laboratory and field analyses is comparable and fit for purpose. Ecological assessment techniques involve both a field and a laboratory component; each of these needs to be scientifically robust. Implementation of interlaboratory comparison studies falls into two broad categories; interlaboratory tests designed to demonstrate comparability of data produced by laboratories which are working independently or in separate geographical regions [1] and routine procedures implemented by the laboratories as part of their operational methods.
Existing systems of interlaboratory comparison are generally not well developed for ecological assessments. By their nature the techniques used should be specific to the organism group and may not be readily transferable to other applications. This standard provides general guidance on the design of such systems.
SIST EN 16101:2013
EN 16101:2012 (E) 5 1 Scope This European Standard provides guidance on interlaboratory comparison with a special focus on biological methods. Guidance on the methods and procedures given in this standard should ensure that field survey results and laboratory analyses are comparable within specified limits. This guidance enables participants in interlaboratory comparison to demonstrate their level of performance. In addition it provides a mechanism for quality improvement. This standard describes a general course of the procedure. Detailed elements can be found in EN 14996, EN ISO/IEC 17000, EN ISO/IEC 17025, and EN ISO/IEC 17043. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. 2.1 assigned value value attributed to a particular property of a proficiency test item Note 1 to entry: ISO 13528:2005, 3.3, refers to this term as ‘Value attributed to a particular quantity and accepted, sometimes by convention, as having an uncertainty appropriate for a given purpose’.
[SOURCE: EN ISO/IEC 17043:2010, 3.1, modified – Note 1 to entry has been added] 2.2 interlaboratory 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 Note 1 to entry: ISO 13528:2005, 3.1, refers to this term as ‘organisation, performance and evaluation of tests on the same or similar test items by two or more laboratories in accordance with predetermined conditions’.
Note 2 to entry: The data under test may be qualitative, quantitative, continuous or discrete, and derived from laboratory analysis or field survey. [SOURCE: EN ISO/IEC 17043:2010, 3.4, modified – Note 1 and 2 to entry have been added] 2.3
participant laboratory, organisation or individual that receives proficiency test items and submits results for review by the proficiency testing provider Note 1 to entry: In case of testing field survey methods, e.g. assessing hydro-morphological characteristics of water bodies, test items can by river stretches or lake shore length selected for survey by the participant. [SOURCE: EN ISO/IEC 17043:2010, 3.6, modified – Note 1 to entry has been added] 2.4 proficiency testing evaluation of participant performance against pre-established criteria by means of interlaboratory comparisons
Note 1 to entry: For the purposes of this International Standard, the term “proficiency testing” is taken in its widest sense and includes, but is not limited to:
a) quantitative scheme — where the objective is to quantify one or more measurands of the proficiency test item;
b) qualitative scheme — where the objective is to identify or describe one or more characteristics of the proficiency test item;
SIST EN 16101:2013
EN 16101:2012 (E) 6 c) sequential scheme — where one or more proficiency test items are distributed sequentially for testing or measurement and returned to the proficiency testing provider at intervals;
d) simultaneous scheme — where proficiency test items are distributed for concurrent testing or measurement within a defined time period;
e) single occasion exercise — where proficiency test items are provided on a single occasion;
f) continuous scheme — where proficiency test items are provided at regular intervals;
g) sampling — where samples are taken for subsequent analysis; and
h) data transformation and interpretation — where sets of data or other information are furnished and the information is processed to provide an interpretation (or other outcome).
Note 2 to entry: Some providers of proficiency testing in the medical area use the term “External Quality Assessment (EQA)” for their proficiency testing schemes, or for their broader programs, or both (see Annex A). The requirements of this International Standard cover only those EQA activities that meet the definition of proficiency testing. Note 3 to entry: ISO 13528:2005, 3.2, refers to this term as ‘determination of laboratory testing performance by means of interlaboratory comparisons’. [SOURCE: EN ISO/IEC 17043:2010, 3.7, modified – Note 3 to entry has been added] 2.5 single occasion exercise proficiency test items provided on a single occasion 2.6 standard deviation for proficiency assessment measure of dispersion used in the evaluation of results of proficiency testing, based on the available information
Note 1 to entry: The standard deviation applies only to ratio and differential scale results. Note 2 to entry: Not all proficiency testing schemes evaluate proficiency based on the dispersion of results. Note 3 to entry: ISO 13528:2005, 3.2, refers to this term as ‘standard deviation used in the assessment of proficiency which may be related to the reproducibility standard deviation or to a statement of the fitness for purpose of the measurement method’. [SOURCE: EN ISO/IEC 17043:2010, 3.13, modified – Note 3 to entry has been added] 2.7 z-score one of the standardised measures of laboratory bias, calculated using the assigned value and the standard deviation for proficiency assessment (applicable to continuous data only) [SOURCE: ISO 13528:2005, 3.5] 3 Principle Results of biological and ecological assessments from laboratories across the European Union are increasingly used to inform decision making and investment programmes. There is a clear need to ensure that these assessments are based upon sound science and validated data, comparable between laboratories within member states and between member states. Effective interlaboratory comparisons are based on the adoption of procedures to quantify and control process errors (Clause 4) within specified limits, and to enable participants to demonstrate that their analyses fulfil requirements for quality, and to maintain their SIST EN 16101:2013
EN 16101:2012 (E) 7 performance. This guidance standard describes the principles required for effective interlaboratory comparisons, as well as permitting laboratories to apply appropriate corrective action in relation to both analyst performance and analytical results, thereby driving improvement in quality. Interlaboratory comparison does not exist in isolation as it is part of a framework on quality assurance, which must not ignore the human dimension (e. g. significant recent experience of professionals and repeated instruction). The selection of a suitable method for interlaboratory comparison will depend on several factors including: the required level of comparability between individuals and laboratories; an analysis of the data types generated during ecological assessments (see Note below); an understanding of the statistical distribution of the data; sources of variability in the methods used. A key step in the process of interlaboratory comparison is the determination of the assigned value for a taxon, the count or estimate of abundance, or the value of a particular parameter associated with the taxon (e.g. the mean body weight or length). NOTE Data types are usually either continuous data, which are obtained by counting of individuals or measuring the size of individuals, or categorical data, which are obtained when estimator scales are applied, e.g. for assessing some morphological aspects of rivers or the abundance or size of organisms in “classes”. This standard provides an overview on interlaboratory comparisons and guidance on method selection for commonly used ecological assessments. Supporting details of quality managing systems relating to documentation, training and instrument calibration are described in EN ISO/IEC 17025. General requirements on proficiency testing are described in EN ISO/IEC 17043. For specific quality issues in ecological assessments additional detail is provided in EN 14996. 4 Procedures 4.1 General concepts The quantitative and qualitative investigation of information on biological and ecological samples is usually based on biological taxa and their abundance, and in some cases on other data describing properties of individuals (e.g. body length of fish). These investigations are regulated by either European or national standards. Depending on the type of organisms assessed methods differ and therefore the approach of comparing the results shall respect the peculiarities of the applied methods.
In general the comparison of each stage of the sampling and investigation process should occur within the limits of applicability. This starts with sampling strategies, followed by sampling procedures (especially field analyses, see 4.2), sample processing, sample analysis (including lab methods, see 4.2), etc. Knowledge is needed therefore on sources of variability. The fundamental concept of survey design should be defined by the quality of the output and the purpose for what it is to be used such as absolute value or Ecological Quality Ratio (EQR, an output for the European Water Framework Directive) or a classification. European Standards shall be used where they exist.
Several approaches exist for the comparison of ecological data (see [1]) on which interlaboratory comparison methods for field survey data can be based. The selection of an appropriate design of an interlaboratory comparison shall first relate to the exact methods used and on the level of taxonomic resolution, and the method of investigation of other than taxonomic data. In a next step guidance shall be given on the statistical methods to be applied, and on the skills of the analysts involved. To ensure good results all individuals involved in field surveys as well as in lab procedures should have training programs on the methods and the taxonomy of the type of organisms assessed. The comparison of identification skills is the first step, which should be followed by testing the proper use of the sampling equipment. In the event of perceived quality defects traceability throughout sampling, analysis, data handling and production of final reports is an essential element for identifying sources of error in the process. For interlaboratory comparison the minimum number of participants shall be defined according to the method SIST EN 16101:2013
EN 16101:2012 (E) 8 tested and related statistical properties of data produced by this method. Training files and records of competence should be maintained. NOTE Further details are given in Annexes A to C: Annex A: Approaches in interlaboratory comparison; Annex B: Statistical analysis; Annex C: Characteristics associated with measurement procedure in biological methods. 4.2 Field survey Field survey comparison starts with defining the methodology specific to the selected organism group. Then the objectives of the subsequent data use should be set and the educational level of the operators should be selected as suited to purpose. Identify the optimum season for survey along with sampling frequency and, whenever possible, take replicates, and define the sample size (e.g. the number of samples, or the volume taken, or the area from which samples are taken). For each biotic element the concrete methodological approach will be different. Identify methods for how the sample sites are selected to best meet the objectives of the survey place. Apply quality assurance (QA) mechanisms like repeat survey, etc. If not regulated according to other standards (e.g. Multi-Habitat sampling for macro invertebrate investigation; site selection procedures for macrophyte investigation) samples should be randomised and duplicates should be taken where appropriate. The sampling procedure shall include details on fixing, transport and storage of samples, where sample stability may be an issue. Validate and optimise the performance characteristics of the techniques used and report precision (see C.2) and detection limits of methods. The implementation of expert panels providing a “consensus” on complex or ambiguous results is an appropriate procedure to deal with special aspects of methods or groups of organisms. Where a step-by-step approach on methodological errors is impractical a global estimate of sampling error may fit the need for a standardised procedure. For example, a global estimate may be used, if results are based on methods where qualitative scales (“estimator scales”) instead of numerical investigation are used. 4.3 Laboratory aspects Intra-laboratory investigations of operator performance are essential compo
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