Footwear and footwear components - Test method to assess antibacterial activity (ISO 16187:2025)

This document specifies quantitative test methods to evaluate the antibacterial activity of footwear and footwear components.
This document is applicable to all types of footwear and footwear components employing non-diffusing antibacterial treatments.

Schuhe und Schuhbestandteile - Prüfverfahren zur Bestimmung der antibakteriellen Wirkung (ISO 16187:2025)

Dieses Dokument legt quantitative Prüfverfahren zur Bewertung der antibakteriellen Wirkung von Schuhen und Schuhbestandteilen fest.
Dieses Dokument ist anwendbar auf alle Arten von Schuhen und Schuhbestandteilen, die eine nicht-diffundierende antibakterielle Behandlung aufweisen.
ACHTUNG — Die in diesem Dokument festgelegten Prüfverfahren erfordern die Verwendung von Bakterien. Diese Prüfungen dürfen ausschließlich in Einrichtungen mit Eindämmungstechniken für den Umgang mit Mikroorganismen und durch geschultes und mit den mikrobiologischen Techniken vertrautes Personal durchgeführt werden.

Chaussure et composants de chaussure - Méthode d'essai pour évaluer l'activité antibactérienne (ISO 16187:2025)

Le présent document spécifie des méthodes d’essai quantitatives permettant d’évaluer l’activité antibactérienne de chaussures et de leurs composants.
Le présent document s’applique à tous les types de chaussures et de composants de chaussure faisant l’objet de traitements antibactériens non migrants.

Obutev in deli obutve - Preskusna metoda za ugotavljanje protibakterijskega delovanja (ISO 16187:2025)

Ta dokument določa kvantitativne preskusne metode za vrednotenje protibakterijskega delovanja v obutvi in delih obutve. Ta dokument se uporablja za vse tipe obutve in delov obutve, ki so bili obdelani z nerazpršitvenim protibakterijskim postopkom.

General Information

Status
Published
Public Enquiry End Date
25-Oct-2023
Publication Date
01-Apr-2025
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
13-Mar-2025
Due Date
18-May-2025
Completion Date
02-Apr-2025

Relations

Standard
SIST EN ISO 16187:2025
English language
21 pages
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Standards Content (Sample)


SLOVENSKI STANDARD
01-maj-2025
Obutev in deli obutve - Preskusna metoda za ugotavljanje protibakterijskega
delovanja (ISO 16187:2025)
Footwear and footwear components - Test method to assess antibacterial activity (ISO
16187:2025)
Schuhe und Schuhbestandteile - Prüfverfahren zur Bestimmung der antibakteriellen
Wirkung (ISO 16187:2025)
Chaussure et composants de chaussure - Méthode d'essai pour évaluer l'activité
antibactérienne (ISO 16187:2025)
Ta slovenski standard je istoveten z: EN ISO 16187:2025
ICS:
61.060 Obuvala Footwear
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 16187
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2025
EUROPÄISCHE NORM
ICS 61.060 Supersedes EN ISO 16187:2013
English Version
Footwear and footwear components - Test method to
assess antibacterial activity (ISO 16187:2025)
Chaussure et composants de chaussure - Méthode Schuhe und Schuhbestandteile - Prüfverfahren zur
d'essai pour évaluer l'activité antibactérienne (ISO Bestimmung der antibakteriellen Wirkung (ISO
16187:2025) 16187:2025)
This European Standard was approved by CEN on 4 March 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 16187:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 16187:2025) has been prepared by Technical Committee ISO/TC 216
"Footwear" in collaboration with Technical Committee CEN/TC 309 “Footwear” the secretariat of which
is held by UNE.
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 September 2025, and conflicting national standards
shall be withdrawn at the latest by September 2025.
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 16187:2013.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. 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 16187:2025 has been approved by CEN as EN ISO 16187:2025 without any modification.

International
Standard
ISO 16187
Second edition
Footwear and footwear
2025-02
components — Test method to
assess antibacterial activity
Chaussure et composants de chaussure — Méthode d'essai pour
évaluer l'activité antibactérienne
Reference number
ISO 16187:2025(en) © ISO 2025
ISO 16187:2025(en)
© ISO 2025
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 16187:2025(en)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 1
5 Safety . 2
6 Apparatus . 2
7 Reagents and culture medium . 2
7.1 General .2
7.2 Water .3
7.3 Nutrient broth (NB) .3
7.3.1 Composition .3
7.3.2 Preparation .3
7.4 Nutrient agar (NA) .3
7.4.1 Composition .3
7.4.2 Preparation .3
7.5 Tryptic soy broth (TSB) .4
7.5.1 Composition .4
7.5.2 Preparation .4
7.6 Tryptone soy agar (TSA) .4
7.6.1 Composition .4
7.6.2 Preparation .4
7.7 Soybean casein digest broth with lecithin and polyoxyethylene medium (SCDLP) .4
7.7.1 Composition .4
7.7.2 Preparation .5
7.8 Sodium chloride solution (physiological saline).5
7.8.1 Composition .5
7.8.2 Preparation .5
8 Test microorganisms . 5
8.1 Test strains.5
8.2 Storage of strains .5
9 Preparation of test inoculums . 6
10 Preparation of test samples . 6
10.1 General .6
10.2 Test specimen .6
10.3 Pre-treatment of the test specimen .6
11 Test procedure . 6
12 Expression of results . 7
12.1 Calculation of the number of viable bacteria .7
12.2 Judgement of test effectiveness .7
12.3 Calculation of antibacterial activity ratio .8
13 Test report . 8
Annex A (normative) Static challenge test .10
Annex B (normative) Film contact method .11
Annex C (normative) Dynamic challenge test.13
Bibliography . 14

iii
ISO 16187:2025(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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 216, Footwear, in collaboration with the
European Committee for Standardization (CEN) Technical Committee CEN/TC 309, Footwear, in accordance
with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 16187:2013), which has been technically
revised.
The main changes are as follows:
— a new term “neutralizer” and its definition have been added;
— a new Clause 4 has been added;
— AS No. has been revised to CGMCC No.;
— the light intensity of UV lamp has been added;
— the normative references and bibliography have been revised and updated;
— TSA and TSB have been added as alternative culture medium if NA and NB are not available;
— Annex D has been deleted.
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 16187:2025(en)
Footwear and footwear components — Test method to assess
antibacterial activity
CAUTION — Test methods specified in this document require the use of bacteria. These tests shall
only be carried out in facilities with containment techniques for handling microorganisms and by
persons with training and experience in the use of microbiological techniques.
1 Scope
This document specifies quantitative test methods to evaluate the antibacterial activity of footwear and
footwear components.
This document is applicable to all types of footwear and footwear components employing non-diffusing
antibacterial treatments.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 7218, Microbiology of the food chain — General requirements and guidance for microbiological examinations
ISO 19952, Footwear — Vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 19952 and the following 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
antibacterial activity
efficacy of a material or finish used to prevent or mitigate the growth of bacteria, to reduce the number of
bacteria or to kill bacteria
3.2
control sample
material identical to the test material but without antibacterial treatment
3.3
neutralizer
chemical agent used to inactivate, neutralize, or quench the antibacterial properties of antibacterial agents
4 Principle
The test specimens and control specimens are inoculated with a bacterial suspension of a selected test
strain specified or claimed in independent tests with one Gram-positive and one Gram-negative bacterial
test organism.
ISO 16187:2025(en)
Three test methods are available to assess antibacterial activity in a challenge test procedure under static
or under dynamic conditions.
Antibacterial performance is quantitatively determined by counting the number of viable cells and
calculating the antibacterial activity ratio.
5 Safety
Handling of microorganisms which are potentially hazardous requires a high degree of technical competence
and can be subject to current national legislation and regulations. Only personnel trained in microbiological
techniques should carry out such tests.
NOTE Refer to country-specific codes of practice for personal hygiene, disinfection and sterilization.
Persons who perform the test should consult IEC 60068-2-10:2005/AMD1:2018, Annex A, and ISO 7218.
6 Apparatus
Disposable apparatus is an acceptable alternative to re-usable glassware and plastic if it has the suitable
specifications.
Apparatus includes usual microbiological laboratory equipment in accordance with ISO 7218 and, in
particular, the following.
6.1 Biological safety cabinet.
6.2 Incubator, capable of maintaining a temperature of (37 ± 2) °C.
6.3 Autoclave, capable of maintaining a temperature of (121 ± 2) °C and a pressure of (103 ± 5) kPa, for
wet sterilization, used in accordance with ISO 7218.
6.4 Humidity chamber, capable of maintaining a temperature of (37 ± 2) °C and a relative humidity of
(85 ± 5) %.
6.5 Ultraviolet lamp, capable of emitting light intensity of 100 000 μWs/cm .
6.6 Wide mouth jars, with cap, 100 ml, capable of being used with an autoclave (6.3).
6.7 Cover film, that does not affect bacterial growth or absorb water, which can be made of either
polyethylene, polypropylene or polyester [poly (ethylene terephthalate)]. Film that is 0,05 mm to 0,10 mm
thick should be used. For example, disposal bag suitable for use with an autoclave (6.3).
6.8 Vortex mixer.
6.9 Dimensional shaker, t
...

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