EN ISO 13843-2017 en Water quality - Requirements for establishing performance characteristics of quantitative microbiological methods.pdf

1、Water quality - Requirements for establishing performance characteristics of quantitative microbiological methodsBS EN ISO 13843:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13843 July 2017 ICS 07.100.20

2、 Supersedes ENV ISO 13843:2001English Version Water quality - Requirements for establishing performance characteristics of quantitative microbiological methods (ISO 13843:2017) Qualit de leau - Exigences pour ltablissement des caractristiqes de performance des mthodes microbiologiques quantitatives

3、(ISO 13843:2017) Wasserbeschaffenheit - Anforderungen zur Bestimmung von Leistungsmerkmalen von quantitativen mikrobiologischen Verfahren (ISO 13843:2017) This European Standard was approved by CEN on 5 June 2017. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipul

4、ate 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 St

5、andard 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 n

6、ational 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,

7、Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and

8、 by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 13843:2017 ENational forewordThis British Standard is the UK implementation of EN ISO 13843:2017. It is identical to ISO 13843:2017. It supersedes DD ENV ISO/TR 13843:2001 which is withdrawn.The UK participation in its prepar

9、ation was entrusted to Technical Committee EH/3/4, Microbiological methods.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct

10、application. The British Standards Institution 2017Published by BSI Standards Limited 2017ISBN 978 0 580 82104 2ICS 07.100.20Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy C

11、ommittee on 31 August 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 13843:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13843 July 2017 ICS 07.100.20 Supersedes ENV ISO 13843:2001English Version Water quality - Requirements for establis

12、hing performance characteristics of quantitative microbiological methods (ISO 13843:2017) Qualit de leau - Exigences pour ltablissement des caractristiqes de performance des mthodes microbiologiques quantitatives (ISO 13843:2017) Wasserbeschaffenheit - Anforderungen zur Bestimmung von Leistungsmerkm

13、alen von quantitativen mikrobiologischen Verfahren (ISO 13843:2017) This European Standard was approved by CEN on 5 June 2017. 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

14、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 ot

15、her 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

16、, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EURO

17、PEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 13843:2017 E

18、BS EN ISO 13843:2017EN ISO 13843:2017 (E) 2 European foreword This document (EN ISO 13843:2017) has been prepared by Technical Committee ISO/TC 147 “Water quality“ in collaboration with Technical Committee CEN/TC 230 “Water analysis” the secretariat of which is held by DIN. This European Standard sh

19、all be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by January 2018 and conflicting national standards shall be withdrawn at the latest by January 2018. Attention is drawn to the possibility that some of the elements of this doc

20、ument may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document supersedes ENV ISO 13843:2001. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to imp

21、lement 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, Romani

22、a, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 13843:2017 has been approved by CEN as EN ISO 13843:2017 without any modification. ISO 13843:2017(E)Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and def

23、initions . 14 Basic concepts . 64.1 General . 64.2 Characterization 74.3 Verification . 84.4 Method comparison 84.5 Samples . 95 Specifications: some guideline values 96 Designs for determining performance characteristics of a method 106.1 General considerations . 106.2 Determination of sensitivity,

24、 specificity, efficiency, selectivity, false positive rate and false negative rate . 106.2.1 Type of samples to be used 106.2.2 Number of samples .116.2.3 Procedure 116.2.4 Categorical performance characteristics .116.2.5 Worked example 126.3 Determination of the upper limit and consideration of the

25、 lower limit of detection .146.3.1 Working range .146.3.2 Upper limit related to linearity. 146.3.3 Type and number of samples to be used .146.3.4 Worked example 156.3.5 The lower limit of detection 166.4 Assessment of precision: Determination of repeatability and reproducibility 166.4.1 General. 16

26、6.4.2 Repeatability 176.4.3 Intralaboratory reproducibility .186.5 Robustness 206.5.1 General. 206.5.2 Experimental designs for effects due to time and temperature 206.6 Relative recovery 216.6.1 General. 216.6.2 Determination of relative recovery .216.7 Uncertainty of counting 226.7.1 General. 226.

27、7.2 Experimental design for assessing the uncertainty of counting colonies .226.7.3 Example of individual (or personal) uncertainty of counting colonies .226.7.4 Example of intralaboratory uncertainty of counting colonies 236.7.5 Example of intralaboratory uncertainty of reading MPN 237 Designs for

28、single laboratory verification of a method .247.1 General considerations . 247.2 Calculation of sensitivity, specificity, efficiency, selectivity, false positive rate and false negative rate 247.2.1 Type of sample to be used 247.2.2 Number of samples .257.2.3 Procedure for confirmation . 257.2.4 Cat

29、egorical performance characteristics .257.3 Determination of repeatability 26 ISO 2017 All rights reserved iiiContents PageBS EN ISO 13843:2017ISO 13843:2017(E)Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 14 Basic concepts . 64.1 General . 64.2 Characterizati

30、on 74.3 Verification . 84.4 Method comparison 84.5 Samples . 95 Specifications: some guideline values 96 Designs for determining performance characteristics of a method 106.1 General considerations . 106.2 Determination of sensitivity, specificity, efficiency, selectivity, false positive rate and fa

31、lse negative rate . 106.2.1 Type of samples to be used 106.2.2 Number of samples .116.2.3 Procedure 116.2.4 Categorical performance characteristics .116.2.5 Worked example 126.3 Determination of the upper limit and consideration of the lower limit of detection .146.3.1 Working range .146.3.2 Upper l

32、imit related to linearity. 146.3.3 Type and number of samples to be used .146.3.4 Worked example 156.3.5 The lower limit of detection 166.4 Assessment of precision: Determination of repeatability and reproducibility 166.4.1 General. 166.4.2 Repeatability 176.4.3 Intralaboratory reproducibility .186.

33、5 Robustness 206.5.1 General. 206.5.2 Experimental designs for effects due to time and temperature 206.6 Relative recovery 216.6.1 General. 216.6.2 Determination of relative recovery .216.7 Uncertainty of counting 226.7.1 General. 226.7.2 Experimental design for assessing the uncertainty of counting

34、 colonies .226.7.3 Example of individual (or personal) uncertainty of counting colonies .226.7.4 Example of intralaboratory uncertainty of counting colonies 236.7.5 Example of intralaboratory uncertainty of reading MPN 237 Designs for single laboratory verification of a method .247.1 General conside

35、rations . 247.2 Calculation of sensitivity, specificity, efficiency, selectivity, false positive rate and false negative rate 247.2.1 Type of sample to be used 247.2.2 Number of samples .257.2.3 Procedure for confirmation . 257.2.4 Categorical performance characteristics .257.3 Determination of repe

36、atability 26 ISO 2017 All rights reserved iiiContents PageBS EN ISO 13843:2017ISO 13843:2017(E)7.4 Uncertainty of counting 267.5 Procedure for single laboratory verification 26Annex A (informative) Mathematical models of variation30Annex B (normative) Assessment of the lower limits 40Annex C (normat

37、ive) Assessment of the upper limit 43Annex D (normative) Determination of the operational variability in repeatability and intralaboratory reproducibility conditions 44Annex E (normative) Uncertainty of counting .48Annex F (normative) Determination of the operational variability (interlaboratory rep

38、roducibility) in a collaborative performance study 50Annex G (informative) Glossary of principal symbols .58Bibliography .60iv ISO 2017 All rights reservedBS EN ISO 13843:2017ISO 13843:2017(E)7.4 Uncertainty of counting 267.5 Procedure for single laboratory verification 26Annex A (informative) Mathe

39、matical models of variation30Annex B (normative) Assessment of the lower limits 40Annex C (normative) Assessment of the upper limit 43Annex D (normative) Determination of the operational variability in repeatability and intralaboratory reproducibility conditions 44Annex E (normative) Uncertainty of

40、counting .48Annex F (normative) Determination of the operational variability (interlaboratory reproducibility) in a collaborative performance study 50Annex G (informative) Glossary of principal symbols .58Bibliography .60iv ISO 2017 All rights reserved ISO 13843:2017(E)ForewordISO (the International

41、 Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been est

42、ablished has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardiz

43、ation.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance wi

44、th the editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of a

45、ny patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www .iso .org/ patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorse

46、ment.For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following UR

47、L: www .iso .org/ iso/ foreword .html.This document was prepared by Technical Committee ISO/TC 147, Water quality, Subcommittee SC 4, Microbiological methods.This first edition of ISO 13843 cancels and replaces ISO/TR 13843:2000, which has been technically revised. ISO 2017 All rights reserved vBS E

48、N ISO 13843:2017ISO 13843:2017(E)IntroductionMethods are considered microbiological when the quantitative estimate is based on counting of microbial particles either directly with the aid of a microscope or indirectly on the basis of growth (multiplication) into colonies, turbidity, a colour change

49、or fluorescence. The principles and procedures within the scope of this document are commonly known as microscopic count, most probable number (MPN) and colony count. Most of the procedures for the determination of performance characteristics described in this document are applicable to all three types of method. However, where the procedures are not applicable, alternative suggestions are made within the body of the document or in Annexes D and E (for repeatability, reproducibility and uncertainty of counting).Plaque counts of bacteriophages ar