EN ISO 23196:2023
(Main)Water quality - Calculation of biological equivalence (BEQ) concentrations (ISO 23196:2022)
Water quality - Calculation of biological equivalence (BEQ) concentrations (ISO 23196:2022)
This document specifies the derivation of biological equivalence (BEQ) concentrations for results of in vitro bioassays which are based on measuring effects on a biological process such as enzyme induction or cellular growth. The concept described here can be used for any biological assay after the proof of its applicability.
To derive BEQ concentrations, the effect on a biological process caused by a sample – i.e. the activity of the sample – is expressed in terms of a concentration of a reference compound which results in an equivalent effect on the process. The term "sample" used in this document addresses environmental samples as well as defined mixtures and pure compounds used as test item in a bioassay. BEQ concentrations can be derived for environmental water samples, extracts of environmental water samples including tap water or solutions of pure chemicals or mixtures of chemicals.
Wasserbeschaffenheit - Berechnung biologischer Äquivalenzkonzentrationen (BEQ) (ISO 23196:2022)
Dieses Dokument legt die Ableitung von biologischen Äquivalenzkonzentrationen (BEQ) für Ergebnisse von in-vitro-Bioassays fest, die auf der Messung von Effekten auf biologische Prozesse wie eine Enzyminduktion oder Zellwachstum beruhen. Das hier beschriebene Konzept kann nach dem Nachweis seiner Anwendbarkeit für jeden biologischen Assay verwendet werden.
Zur Ableitung einer BEQ-Konzentration wird der durch eine Probe verursachte Effekt auf einen biologischen Prozess – d. h. die Aktivität der Probe – als Konzentration einer Referenzverbindung ausgedrückt, die einen gleichen Effekt hervorruft. Der in diesem Dokument verwendete Begriff „Probe“ bezieht sich sowohl auf Umweltproben als auch auf definierte Gemische und reine Verbindungen, die als Prüfgegenstand in einem Bioassay verwendet werden. BEQ-Konzentrationen können für wässrige Umweltproben, Extrakte von wässrigen Umweltproben einschließlich Leitungswasser oder Lösungen von reinen Chemikalien oder Chemikaliengemischen abgeleitet werden.
Qualité de l'eau - Calcul des concentrations en équivalent biologique (BEQ) (ISO 23196:2022)
Le présent document spécifie la détermination de concentrations en équivalent biologique (BEQ) à partir de résultats de bioessais in vitro qui sont fondés sur la mesure des effets produits sur un processus biologique tel que l’induction d’enzymes ou la croissance cellulaire. Le concept décrit ici peut être utilisé pour n’importe quel bioessai du moment que son applicabilité a été démontrée.
Pour déterminer les concentrations BEQ, l’effet produit par un échantillon sur un processus biologique, c’est-à-dire l’activité de l’échantillon, est exprimé sous la forme de la concentration d’un composé de référence à laquelle un effet équivalent est obtenu sur le processus. Le terme «échantillon» utilisé dans le présent document renvoie à des échantillons environnementaux ainsi qu’à des mélanges déterminés et à des composés purs utilisés comme objets de mesure dans le cadre d’un bioessai. Les concentrations en équivalent biologique peuvent être déterminées pour des échantillons d’eau environnementaux, des extraits d’échantillons d’eau environnementaux, y compris d’eau du robinet, ou des solutions de substances chimiques pures ou de mélanges de substances chimiques.
Kakovost vode - Izračun biološko ekvivalentnih koncentracij (BEQ) (ISO 23196:2022)
Ta dokument določa izpeljavo biološko ekvivalentnih koncentracij (BEQ) za rezultate bioloških preskusov in vitro, ki temeljijo na merjenju učinkov bioloških procesov, kot je indukcija encimov ali celična rast. Koncept, opisan v tem dokumentu, je mogoče uporabiti za kateri koli biološki preskus z dokazano uporabnostjo.
Za izpeljavo biološko ekvivalentnih koncentracij (BEQ) je učinek biološkega procesa, ki ga sproži vzorec – tj. aktivnost vzorca – izražen kot koncentracija referenčne spojine, ki je posledica enakovrednega učinka na proces. Izraz »vzorec« se v tem dokumentu nanaša na okoljske vzorce in opredeljene mešanice in čiste spojine, ki se uporabljajo kot preskušanec v biološkem preskusu. Biološko ekvivalente koncentracije je mogoče izpeljati iz vzorcev vode iz okolja, ekstraktov vzorcev vode iz okolja, vključno z vodo iz pipe ali raztopin čistih kemikalij ali mešanice kemikalij.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2024
Kakovost vode - Izračun biološko ekvivalentnih koncentracij (BEQ) (ISO
23196:2022)
Water quality - Calculation of biological equivalence (BEQ) concentrations (ISO
23196:2022)
Wasserbeschaffenheit - Berechnung biologischer Äquivalenzkonzentrationen (BEQ)
(ISO 23196:2022)
Qualité de l'eau - Calcul des concentrations en équivalent biologique (BEQ) (ISO
23196:2022)
Ta slovenski standard je istoveten z: EN ISO 23196:2023
ICS:
13.060.70 Preiskava bioloških lastnosti Examination of biological
vode properties of water
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 23196
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2023
EUROPÄISCHE NORM
ICS 13.060.70
English Version
Water quality - Calculation of biological equivalence (BEQ)
concentrations (ISO 23196:2022)
Qualité de l'eau - Calcul des concentrations en Wasserbeschaffenheit - Berechnung biologischer
équivalent biologique (BEQ) (ISO 23196:2022) Äquivalenzkonzentrationen (BEQ) (ISO 23196:2022)
This European Standard was approved by CEN on 21 August 2023.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23196:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
The text of ISO 23196:2022 has been prepared by Technical Committee ISO/TC 147 "Water quality” of
the International Organization for Standardization (ISO) and has been taken over as EN ISO 23196:2023
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 or by endorsement, at the latest by February 2024, and conflicting national standards
shall be withdrawn at the latest by February 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 23196:2022 has been approved by CEN as EN ISO 23196:2023 without any modification.
INTERNATIONAL ISO
STANDARD 23196
First edition
2022-02
Water quality — Calculation of
biological equivalence (BEQ)
concentrations
Reference number
ISO 23196:2022(E)
ISO 23196:2022(E)
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
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Published in Switzerland
ii
ISO 23196:2022(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 2
5 Procedure .5
5.1 General . 5
5.2 Procedure for the calculation of biological equivalence (BEQ) concentrations . 5
5.2.1 Assessment of the suitability of the experimental data for the calculation
of a biological equivalence (BEQ) concentration . 5
5.2.2 Fitting of concentration-effect data for the reference compound . 8
5.2.3 Calculation of quality measures for the fit . 9
5.2.4 Normalization of data from the reference compound and samples . 10
5.2.5 Calculation of the x %-effect level of the reference concentration-effect
relationship and the respective RC -value . 11
x
5.2.6 Assessment of the validity of the experimental data for the calculation of a
biological equivalence (BEQ) concentration .12
5.2.7 Calculation of the concentration factor of the sample at x %-effect level by
linear interpolation .12
5.2.8 Calculation of the biological equivalence (BEQ) concentration .13
6 Validity criteria .14
7 Test report .14
Annex A (informative) Illustration of χ statistics using data from Table 1 .15
Bibliography .18
iii
ISO 23196:2022(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.
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 with 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
any 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 endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 147, Water quality, Subcommittee SC 5,
Biological methods.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
INTERNATIONAL STANDARD ISO 23196:2022(E)
Water quality — Calculation of biological equivalence
(BEQ) concentrations
1 Scope
This document specifies the derivation of biological equivalence (BEQ) concentrations for results of in
vitro bioassays which are based on measuring effects on a biological process such as enzyme induction
or cellular growth. The concept described here can be used for any biological assay after the proof of its
applicability.
To derive BEQ concentrations, the effect on a biological process caused by a sample – i.e. the activity
of the sample – is expressed in terms of a concentration of a reference compound which results in an
equivalent effect on the process. The term "sample" used in this document addresses environmental
samples as well as defined mixtures and pure compounds used as test item in a bioassay. BEQ
concentrations can be derived for environmental water samples, extracts of environmental water
samples including tap water or solutions of pure chemicals or mixtures of chemicals.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
biological equivalence concentration
BEQ concentration
concentration of a reference compound (3.6) that causes the same effect as the effect measured in a
sample, a sample dilution or a solution containing one or more chemicals
3.2
concentration-effect relationship
response to a concentration gradient of an environmental sample or a known substance or mixture of
substances which is described by pre-determined diagnostic indicators
[SOURCE: ISO 6107:2021, 3.127, modified — the term "environmental sample" added; Note 1 to entry
has been deleted.]
3.3
concentration factor
CF
ratio of the actual concentration of the sample compared to the original sample taking all enrichment
and dilution steps of the sample into account
ISO 23196:2022(E)
3.4
limit of quantification
LOQ
lowest value of a determinant that can be determined with an acceptable level of accuracy and precision
[SOURCE: ISO 15839:2003, 3.18]
3.5
negative control material
well characterized material and/or substance that, when evaluated by a specific test method,
demonstrates the suitability of the test system to yiel
...
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