1、December 2012 Translation by DIN-Sprachendienst.English price group 12No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).I
2、CS 13.060.45!$“1929057www.din.deDDIN EN 16101Water quality Guidance standard on interlaboratory comparison studies for ecologicalassessment;English version EN 16101:2012,English translation of DIN EN 16101:2012-12Wasserbeschaffenheit Anleitung fr Vergleichsprfungen zwischen Laboratorien fr kologisch
3、eUntersuchungen;Englische Fassung EN 16101:2012,Englische bersetzung von DIN EN 16101:2012-12Qualit de leau Guide pour les tudes comparatives interlaboratoires ayant pour objet lvaluationcologique;Version anglaise EN 16101:2012,Traduction anglaise de DIN EN 16101:2012-12www.beuth.deDocument comprise
4、s pagesIn case of doubt, the German-language original shall be considered authoritative.2111.12 DIN EN 16101:2012-12 2 A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee CEN/TC 230 “Water analysis” (Secretariat: DIN, Germany). The responsi
5、ble German body involved in its preparation was the Normenausschuss Wasserwesen (Water Practice Standards Committee), Working Committee NA 119-01-03-05-06 AK Biologisch-kologische Gewsseruntersuchung of NA 119-01-03 AA Wasseruntersuchung. This standard is part of the series Deutsche Einheitsverfahre
6、n zur Wasser-, Abwasser- und Schlamm-untersuchung Biologisch-kologische Gewsseruntersuchung (Gruppe M) (German standard methods for the examination of water, waste water and sludge Biological-ecological methods of analysis (group M) and describes method M 45. Designation of method M 45: Guidance sta
7、ndard on interlaboratory comparison studies for ecological assessment (M 45): Method DIN EN 16101 M 45 This standard has been published to implement the Water Framework Directive (WFD), Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for
8、 Community action in the field of water policy1). The DIN Standards corresponding to the International Standards and publications referred to in this document are as follows: ISO 13528 DIN ISO 13528 1) Registered in the DITR database of DIN Software GmbH, obtainable from: Beuth Verlag GmbH, 10772 Be
9、rlin. DIN EN 16101:2012-12 3 Expert assistance and specialized laboratories will be required to perform the analyses described in this standard. Existing safety requirements are to be observed. Depending on the objective of the analysis, a check shall be made on a case-by-case basis as to whether an
10、d to what extent additional conditions will have to be specified. German standard methods for the examination of water, waste water and sludge Standard methods published as DIN Standards are obtainable from Beuth Verlag GmbH, either individually or grouped in volumes. The standard methods included i
11、n the loose-leaf publication entitled Deutsche Einheits-verfahren zur Wasser-, Abwasser- und Schlammuntersuchung will continue to be published by Wiley-VCH Verlag and Beuth Verlag GmbH. All standard methods relevant to the Abwasserverordnung (Waste Water Regulation) (AbwV)2) included in the new Regu
12、lation on Section 57, paragraph 1, number 1, of the Gesetz zur Ordnung des Wasserhaushalts (German Water Management Act) concerning Anforderungen an das Einleiten von Abwasser in Gewsser together with the Abwasserverordnung and the Gesetz zur Ordnung des Wasserhaushalts have been published by Beuth
13、Verlag GmbH as a loose-leaf collection Analysenverfahren in der Abwasserverordnung Rechtsvorschriften und Normen (Supplements). Standards or draft standards bearing the group title “German standard methods for the examination of water, waste water and sludge” are classified under the following categ
14、ories (main titles): General information (group A) (DIN 38402) Sensory analysis (group B) (DIN 38403) Physical and physicochemical parameters (group C) (DIN 38404) Anions (group D) (DIN 38405) Cations (group E) (DIN 38406) Substance group analysis (group F) (DIN 38407) Gaseous constituents (group G)
15、 (DIN 38408) Parameters characterizing effects and substances (group H) (DIN 38409) Biological-ecological methods of analysis (group M) (DIN 38410) Microbiological methods (group K) (DIN 38411) Test methods using water organisms (group L) (DIN 38412) Individual constituents (group P) (DIN 38413) Slu
16、dge and sediments (group S) (DIN 38414) Bio-assays with microorganisms (group T) (DIN 38415). In addition to the methods described in the DIN 38402 to DIN 38415 series of standards, there are a number of European and International Standards available as DIN EN, DIN EN ISO and DIN ISO Standards which
17、 also form part of the collection of German standard methods. Information on Parts of these series of standards that have already been published can be obtained from the offices of the Normenausschuss Wasserwesen, telephone +49 (30) 2601-2448, or from Beuth Verlag GmbH, Burggrafenstr. 6, 10787 Berli
18、n. 2) Registered in the DITR database of DIN Software GmbH, obtainable from: Beuth Verlag GmbH, 10772 Berlin. DIN EN 16101:2012-12 4 National Annex NA (informative) Bibliography DIN ISO 13528, Statistical methods for use in proficiency testing by interlaboratory comparisons EUROPEAN STANDARD NORME E
19、UROPENNE EUROPISCHE NORM EN 16101 October 2012 ICS 13.060.45 English Version Water quality - Guidance standard on interlaboratory comparison studies for ecological assessment Qualit de leau - Guide pour les tudes comparatives interlaboratoires ayant pour objet lvaluation cologique Wasserbeschaffenhe
20、it - Anleitung fr Vergleichsprfungen zwischen Laboratorien fr kologische 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
21、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, Germa
22、n). 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,
23、 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 Unite
24、d Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: 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: E
25、EN 16101:2012 (E) 2 Contents Page Foreword 3Introduction .41 Scope 52 Terms and definitions .53 Principle 64 Procedures .7Annex A (normative) Approaches in interlaboratory comparison 10Annex B (informative) Statistical analysis . 12Annex C (informative) Characteristics associated with measurement pr
26、ocedure in biological investigation methods 15Bibliography . 17DIN EN 16101:2012-12 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 stat
27、us 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
28、 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, Bulga
29、ria, 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, Tur
30、key and the United Kingdom. DIN EN 16101:2012-12 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 w
31、ater. 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 t
32、he 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
33、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 ca
34、tegories; 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 interlaborator
35、y 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. DIN EN 16101:2012-1
36、2 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 specifi
37、ed 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,
38、 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 at
39、tributed 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 te
40、sts 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 pre
41、determined 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 i
42、ndividual 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 selec
43、ted 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 Internationa
44、l 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
45、 characteristics of the proficiency test item; DIN EN 16101:2012-12 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 pr
46、oficiency 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
47、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
48、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
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