SIST EN ISO 11350:2025

SLOVENSKI STANDARD
01-november-2025
Kakovost vode - Določanje genotoksičnosti za vodo in odpadno vodo -
Salmonella/mikrosomski fluktuacijski preskus (Amesov fluktuacijski preskus) (ISO
11350:2012)
Water quality - Determination of the genotoxicity of water and waste water -
Salmonella/microsome fluctuation test (Ames fluctuation test) (ISO 11350:2012)
Wasserbeschaffenheit - Bestimmung der Gentoxizität von Wasser und Abwasser -
Verfahren mittels Salmonella/Microsomen-Fluktuationstest (Ames-Fluktuationstest) (ISO
11350:2012)
Qualité de l'eau - Évaluation de la génotoxicité des eaux résiduaires - Essai de
Salmonella/microsome (essai d'Ames-fluctuation) (ISO 11350:2012)
Ta slovenski standard je istoveten z: EN ISO 11350:2025
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 11350
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2025
EUROPÄISCHE NORM
ICS 13.060.70
English Version
Water quality - Determination of the genotoxicity of water
and waste water - Salmonella/microsome fluctuation test
(Ames fluctuation test) (ISO 11350:2012)
Qualité de l'eau - Évaluation de la génotoxicité des eaux Wasserbeschaffenheit - Bestimmung der Gentoxizität
résiduaires - Essai de Salmonella/microsome (essai von Wasser und Abwasser - Verfahren mittels
d'Ames-fluctuation) (ISO 11350:2012) Salmonella/Microsomen-Fluktuationstest (Ames-
Fluktuationstest) (ISO 11350:2012)
This European Standard was approved by CEN on 4 August 2025.

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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11350:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 11350:2012 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 11350:2025
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 2026, and conflicting national standards
shall be withdrawn at the latest by February 2026.
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 11350:2012 has been approved by CEN as EN ISO 11350:2025 without any modification.

INTERNATIONAL ISO
STANDARD 11350
First edition
2012-05-15
Water quality — Determination of the
genotoxicity of water and waste water —
Salmonella/microsome fluctuation test
(Ames fluctuation test)
Qualité de l’eau — Évaluation de la génotoxicité des eaux résiduaires —
Essai de Salmonella/microsome (essai d’Ames-fluctuation)
Reference number
ISO 11350:2012(E)
©
ISO 2012
ISO 11350:2012(E)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved

ISO 11350:2012(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Interferences . 3
5 Principle . 4
6 Apparatus and materials . 4
7 Reagents, media and dilutions . 5
8 Sampling and samples . 9
9 Procedure . 9
9.1 Overnight culture . 9
9.2 Preparation of S9 mix .10
9.3 Testing of water samples .10
9.4 Measurement of revertant growth .13
9.5 Calculation of cytotoxicity .13
10 Validity criteria .14
11 Assessment criteria .14
12 Test report .14
Annex A (normative) Nutrient broth and agar .15
Annex B (normative) Preparation of ampicillin agar plates and stock cultures.16
Annex C (normative) Checking of genotype .17
Annex D (normative) S9 fraction .18
Annex E (informative) Example for application of samples on a 24 well plate .19
Annex F (informative) Example for reporting .21
Annex G (informative) Testing of chemicals .22
Annex H (informative) Precision data.25
Annex I (informative) Statistical assessment .27
Annex J (informative) Measurement of the lowest ineffective dilution (LID) of a waste water —
A simplified evaluation for testing of waste water .33
Annex K (informative) Use of additional tester strains .35
Bibliography .36
ISO 11350:2012(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 2.
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.
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.
ISO 11350 was prepared by Technical Committee ISO/TC 147, Water quality, Subcommittee SC 5,
Biological methods.
iv © ISO 2012 – All rights reserved

INTERNATIONAL STANDARD ISO 11350:2012(E)
Water quality — Determination of the genotoxicity of water and
waste water — Salmonella/microsome fluctuation test (Ames
fluctuation test)
WARNING — Persons using this International Standard should be familiar with normal laboratory
practice. This standard does not purport to address all of the safety problems, if any, associated with
its use. It is the responsibility of the user to establish appropriate safety and health practices and to
ensure compliance with any national regulatory conditions.
IMPORTANT — It is absolutely essential that tests conducted according to this International Standard
be carried out by suitably trained staff.
1 Scope
This International Standard specifies a method for the determination of the genotoxic potential of water and
waste water using the bacterial strains Salmonella enterica subsp. enterica serotype Typhimurium TA 98 and
TA 100 in a fluctuation assay. This combination of strains is able to measure the genotoxicity of chemicals that
induce point mutations (base pair substitutions and frameshift mutations) in genes coding for enzymes that are
involved in the biosynthesis of the amino acid, histidine.
[8]
NOTE 1 ISO 13829 applies for the measurement of genotoxicity of samples containing DNA-crosslinking agents.
This method is applicable to:
— fresh water;
— waste water;
— aqueous extracts and leachates;
— eluates of sediments (fresh water);
— pore water;
— aqueous solutions of single substances or of chemical mixtures;
— drinking water.
NOTE 2 When testing drinking water, extraction and pre-concentration of water samples can prove necessary.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable
for its application. For dated references, only the edition cited applies. For undated references, the latest edition
...