EN ISO 16297:2020

SLOVENSKI STANDARD
01-marec-2020
Nadomešča:
SIST EN ISO 16297:2014
Mleko - Število bakterij - Protokol za vrednotenje alternativnih metod (ISO
16297:2020)
Milk - Bacterial count - Protocol for the evaluation of alternative methods (ISO
16297:2020)
Milch - Bestimmung der Gesamtkeimzahl - Protokoll für die Bewertung alternativer
Verfahren (ISO 16297:2020)
Lait - Dénombrement bactériologique - Protocole pour l'évaluation de méthodes
alternatives (ISO 16297:2020)
Ta slovenski standard je istoveten z: EN ISO 16297:2020
ICS:
67.100.10 Mleko in predelani mlečni Milk and processed milk
proizvodi products
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 16297
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2020
EUROPÄISCHE NORM
ICS 67.100.10 Supersedes EN ISO 16297:2014
English Version
Milk - Bacterial count - Protocol for the evaluation of
alternative methods (ISO 16297:2020)
Lait - Dénombrement bactériologique - Protocole pour Milch - Bestimmung der Gesamtkeimzahl - Protokoll
l'évaluation de méthodes alternatives (ISO für die Bewertung alternativer Verfahren (ISO
16297:2020) 16297:2020)
This European Standard was approved by CEN on 3 January 2020.

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, Turkey 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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16297:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 16297:2020) has been prepared by Technical Committee ISO/TC 34 "Food
products" in collaboration with Technical Committee CEN/TC 302 “Milk and milk products - Methods of
sampling and analysis” the secretariat of which is held by NEN.
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 July 2020, and conflicting national standards shall be
withdrawn at the latest by July 2020.
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.
This document supersedes EN ISO 16297:2014.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 16297:2020 has been approved by CEN as EN ISO 16297:2020 without any modification.

INTERNATIONAL ISO
STANDARD 16297
IDF 161
Second edition
2020-01
Milk — Bacterial count — Protocol for
the evaluation of alternative methods
Lait — Dénombrement bactériologique — Protocole pour
l'évaluation de méthodes alternatives
Reference numbers
ISO 16297:2020(E)
IDF 161:2020(E)
©
ISO and IDF 2020
ISO 16297:2020(E)
IDF 161:2020(E)
© ISO and IDF 2020
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.
ISO copyright office International Dairy Federation
CP 401 • Ch. de Blandonnet 8 Silver Building • Bd Auguste Reyers 70/B
CH-1214 Vernier, Geneva B-1030 Brussels
Phone: +41 22 749 01 11 Phone: +32 2 325 67 40
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Email: copyright@iso.org Email: info@fil-idf.org
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Published in Switzerland
ii © ISO and IDF 2020 – All rights reserved

ISO 16297:2020(E)
IDF 161:2020(E)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Transformation of results . 1
5 Attributes of the alternative method . 2
5.1 General . 2
5.2 Description of the method to be evaluated . 2
5.2.1 Description . . . 2
5.2.2 Checklist . 2
5.3 Measuring range . 2
5.3.1 Lower limit of quantification. 2
5.3.2 Upper limit of quantification . 3
5.3.3 Linearity of the instrument signal . 3
5.4 Carry-over . 4
5.5 Stability . 5
5.6 Precision . 6
5.6.1 General. 6
5.6.2 Repeatability . 6
5.6.3 Reproducibility . 6
5.6.4 Evaluation of factors affecting the results . 6
6 Alternative method as an estimate of the anchor method . 6
6.1 General . 6
6.2 Evaluation of factors affecting the estimation . 7
6.3 Measurement protocol . 7
6.4 Calculations . 7
6.4.1 General. 7
6.4.2 Visual check of a scatter diagram . 7
6.4.3 Outliers . 8
6.4.4 Accuracy of the estimate and accuracy profile . 8
6.5 Attributes of the alternative method expressed in units of the anchor method .10
7 Rating of the elaborated attributes .10
Bibliography .11
ISO 16297:2020(E)
IDF 161:2020(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
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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 34, Food products, Subcommittee SC 5,
Milk and milk p
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