EN 16101:2012
(Main)Water quality - Guidance standard on interlaboratory comparison studies for ecological assessment
Water quality - Guidance standard on 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 process structure. Detailed elements can be found in EN 14996, EN ISO/IEC 17000, EN ISO/IEC 17025, and EN ISO/IEC 17043.
Wasserbeschaffenheit - Anleitung für Vergleichsprüfungen zwischen Laboratorien für ökologische Untersuchungen
Diese Europäische Norm gibt eine Anleitung für Vergleichsprüfungen zwischen Laboratorien mit dem Schwerpunkt auf biologische Verfahren. Die in dieser Norm vorgelegte Anleitung zu Verfahren und Durchführungen sollte sicherstellen, dass Ergebnisse aus Freilanduntersuchungen und Laboranalysen innerhalb festgelegter Grenzen vergleichbar sind. Diese Anleitung ermöglicht es den Teilnehmern einer Vergleichsprüfung zwischen Laboratorien ihre Leistungsfähigkeit darzustellen. Zusätzlich liefert sie ein Regelwerk zur Qualitätsverbesserung. Diese Norm beschreibt ein allgemeines Vorgehen zum Verfahren. Detaillierte Ausführungen sind in EN 14996, EN ISO/IEC 17000, EN ISO/IEC 17025, und EN ISO/IEC 17043 zu finden.
Qualité de l'eau - Guide pour les 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
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
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
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.
[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;
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
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