1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 16101:2012Water quality Guidancestandard on interlaboratorycomparison studies forecological assessmentBS EN 16101:2012 BRITISH STANDARDNational forewordThis British Standar
2、d is the UK implementation of EN 16101:2012. The UK participation in its preparation was entrusted to T e c h n i c a l Committee EH/3/5, Biological Methods.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include
3、all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2012. Published by BSI Standards Limited 2012.ISBN 978 0 580 70704 9 ICS 13.060.45 Compliance with a British Standard cannot confer immunity from legal obligations.This Br
4、itish Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2012.Amendments issued since publicationDate T e x t a f f e c t e dBS EN 16101:2012EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 16101 October 2012 ICS 13.060.45 English Version Wate
5、r quality - Guidance standard on interlaboratory comparison studies for ecological assessment Qualit de leau - Guide pour les tudes comparatives interlaboratoires ayant pour objet lvaluation cologique Wasserbeschaffenheit - Anleitung fr Vergleichsprfungen zwischen Laboratorien fr kologische Untersuc
6、hungen 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 bibliographic
7、al 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
8、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 M
9、acedonia, 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 COMIT EUROPEN DE NORMALISATION
10、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: EBS EN 16101:2012EN 16101:2012 (E) 2 Contents Page Foreword 3Introduction .41 Scop
11、e 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 procedure in biological investigation methods 15Bibliography . 17BS
12、 EN 16101:2012EN 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
13、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 fo
14、r 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, Forme
15、r 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. BS EN 16101:2012EN 16101:2012 (E) 4 Introd
16、uction 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 h
17、ighlighted 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 aquat
18、ic 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
19、 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 da
20、ta 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. B
21、y 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. BS EN 16101:2012EN 16101:2012 (E) 5 1 Scope This European Standard provides guidance on interl
22、aboratory 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 d
23、emonstrate 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 purpose
24、s 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 havi
25、ng 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
26、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,
27、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
28、 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
29、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 incl
30、udes, 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; BS EN 16101:2012EN 16101:2012 (E)
31、 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 d
32、efined 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 interpretat
33、ion 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 scheme
34、s, 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 me
35、ans 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
36、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,
37、 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-s
38、core 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 t
39、he 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 interlaborato
40、ry 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 BS EN 16101:2012EN 16101:2012 (E) 7 performance. This
41、 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
42、 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
43、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 pro
44、cess 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 obtaine
45、d 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 interlaborat
46、ory 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
47、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
48、, 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
49、 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 outp
