ENV ISO 13843:2001
(Main)Water quality - Guidance on validation of microbiological methods (ISO/TR 13843:2000)
Water quality - Guidance on validation of microbiological methods (ISO/TR 13843:2000)
The method is intended for a concentration range to meet the demands of the EC Drinking Water Directive.
Wasserbeschaffenheit - Richtlinie zur Validierung mikrobiologischer Verfahren (ISO/TR 13843:2000)
Anwendungsbereich
Diese Europäische Vornorm befasst sich mit der Validierung mikrobiologischer
Verfahren, mit besonderem Schwerpunkt auf selektive quantitative Verfahren,
bei denen die quantitative Abschätzung auf der Auszählung von Partikeln
beruht, entweder direkt mit Hilfe eines Mikroskops oder indirekt durch Wachs-tum
(Vermehrung) zu Kolonien oder Trübung.Die Grundlagen und Verfahren in diesem Anwendungsbereich sind allgemein
bekannt als presence/absence (P/A), wahrscheinlichste Zahl (most probable
number, MPN), Koloniezählung und direkte (mikroskopische) Zählung.
Diese Europäische Vornorm ist nicht anwendbar auf die Validierung von so
genannten schnellen oder modernen Verfahren, die meist von der Messung von
Produkten oder Änderungen aufgrund mikrobieller Aktivität abhängen, aber
nicht den Nachweis einzelner Partikel ansprechen.
Qualité de l'eau - Lignes directrices pour la validation des méthodes microbiologiques (ISO/TR 13843:2000)
Le présent Rapport technique traite de la validation des méthodes microbiologiques. L'accent est mis sur les méthodes quantitatives sélectives, dans lesquelles l'estimation quantitative repose sur le comptage des particules, soit directement à l'aide d'un microscope, soit indirectement en se basant sur la croissance (multiplication) des colonies ou l'apparition d'une turbidité. Les principes et les modes opératoires entrant dans le domaine d'application sont généralement présence/absence (P/A), le nombre le plus probable (NPP), le comptage de colonies et le comptage (microscopique) direct. Le présent Rapport technique n'est pas applicable à la validation des méthodes dites rapides ou modernes, qui dépendent le plus souvent du mesurage des produits ou des modifications résultant de l'activité microbienne, mais lesquelles ne concernent pas la détection de particules individuelles.
Kakovost vode – Navodilo za validacijo mikrobioloških metod (ISO/TR 13843:2000)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2004
Kakovost vode – Navodilo za validacijo mikrobioloških metod (ISO/TR 13843:2000)
Water quality - Guidance on validation of microbiological methods (ISO/TR 13843:2000)
Wasserbeschaffenheit - Richtlinie zur Validierung mikrobiologischer Verfahren (ISO/TR
13843:2000)
Qualité de l'eau - Lignes directrices pour la validation des méthodes microbiologiques
(ISO/TR 13843:2000)
Ta slovenski standard je istoveten z: ENV ISO 13843:2001
ICS:
07.100.20 Mikrobiologija vode Microbiology of water
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN PRESTANDARD
ENV ISO 13843
PRÉNORME EUROPÉENNE
EUROPÄISCHE VORNORM
May 2001
ICS 07.100.20
English version
Water quality - Guidance on validation of microbiological
methods (ISO/TR 13843:2000)
Qualité de l'eau - Lignes directrices pour la validation des Wasserbeschaffenheit - Richtlinie zur Validierung
méthodes microbiologiques (ISO/TR 13843:2000) mikrobiologischer Verfahren (ISO/TR 13843:2000)
This European Prestandard (ENV) was approved by CEN on 7 April 2001 as a prospective standard for provisional application.
The period of validity of this ENV is limited initially to three years. After two years the members of CEN will be requested to submit their
comments, particularly on the question whether the ENV can be converted into a European Standard.
CEN members are required to announce the existence of this ENV in the same way as for an EN and to make the ENV available promptly
at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the ENV) until the final
decision about the possible conversion of the ENV into an EN is reached.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2001 CEN All rights of exploitation in any form and by any means reserved Ref. No. ENV ISO 13843:2001 E
worldwide for CEN national Members.
Page 2
CORRECTED 2001-08-15
Foreword
The text of the Technical Report from Technical Committee ISO/TC 147 "Water quality" of the
International Organization for Standardization (ISO) has been taken over as a European
Prestandard by Technical Committee CEN/TC 230 "Water analysis", the secretariat of which
is held by DIN.
This European Prestandard shall be given the status of a national standard, either by
publication of an identical text or by endorsement, at the latest by November 2001, and
conflicting national standards shall be withdrawn at the latest by November 2001.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to announce this European Prestandard: Austria, Belgium,
Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,
Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United
Kingdom.
Endorsement notice
The text of the Technical Report ISO/TR 13843:2000 has been approved by CEN as a
European Prestandard without any modifications.
TECHNICAL ISO/TR
REPORT 13843
First edition
2000-06-01
Water quality — Guidance on validation of
microbiological methods
Qualité de l'eau — Lignes directrices pour la validation des méthodes
microbiologiques
Reference number
ISO/TR 13843:2000(E)
©
ISO 2000
ISO/TR 13843:2000(E)
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ii © ISO 2000 – All rights reserved
ISO/TR 13843:2000(E)
Contents Page
Foreword.iv
1 Scope .1
2 Terms and definitions .1
3 Arrangement of the document .8
4 Basic concepts.8
4.1 General.8
4.2 Validation.8
4.3 Detectors .11
4.4 Performance characteristics .11
4.5 Specifications.11
5 Limitations and characteristic features of microbiological methods .12
5.1 Recovery of the analyte .12
5.2 Sample variance.12
5.3 Particle distribution and overdispersion.12
5.4 Interactions in the detector.12
5.5 Robustness .13
5.6 Spurious errors.13
5.7 Control and guidance charts.13
6 Mathematical models of variation.14
6.1 Unavoidable basic variation — The Poisson distribution .14
6.2 Overdispersion — The negative binomial model .17
6.3 Statistical and practical limits .20
6.4 General tests for randomness — Detection of overdispersion .21
7 Specifications — Current practice.21
8 Specifications — Recommended approach.22
9 Determination and expression of performance characteristics .23
9.1 General.23
9.2 Categorical characteristics related to specificity and selectivity.23
9.3 Working limits .24
9.4 Working range of MPN procedures.25
9.5 Precision.25
10 Procedures and steps of validation.26
10.1 General.26
10.2 Primary validation.26
10.3 Secondary validation.28
11 Designs for determining specifications .28
11.1 A general model for basic quantitative specifications .28
11.2 Precision of the entire analytical procedure.29
11.3 Categorical characteristics.29
11.4 Unplanned data.29
Annex A Statistical procedures and computer programs.30
Annex B Numerical examples .34
Annex C Example of a validation experiment.45
Bibliography.46
ISO/TR 13843:2000(E)
Foreword
ISO (the International 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 established 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 standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
The main task of technical committees is to prepare International Standards. Draft International Standards adopted
by the technical committees are circulated to the member bodies for voting. Publication as an International
Standard requires approval by at least 75 % of the member bodies casting a vote.
In exceptional circumstances, when a technical committee has collected data of a different kind from that which is
normally published as an International Standard ("state of the art", for example), it may decide by a simple majority
vote of its participating members to publish a Technical Report. A Technical Report is entirely informative in nature
and does not have to be reviewed until the data it provides are considered to be no longer valid or useful.
Attention is drawn to the possibility that some of the elements of this Technical Report may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO/TR 13843 was prepared by Technical Committee ISO/TC 147, Water quality, Subcommittee SC 4,
Microbiological methods.
iv © ISO 2000 – All rights reserved
TECHNICAL REPORT ISO/TR 13843:2000(E)
Water quality — Guidance on validation of microbiological
methods
1 Scope
This Technical Report deals with validation of microbiological methods, with particular emphasis on selective
quantitative methods in which the quantitative estimate is based on counting of particles either directly, with the aid
of a microscope, or indirectly, on the basis of growth (multiplication) into colonies
...
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