EN ISO 24072:2023

SLOVENSKI STANDARD
01-oktober-2023
Preskusna metoda za zadrževanje bakterij v aerosolu pri napravah za vnos zraka
(ISO 24072:2023)
Aerosol bacterial retention test method for air-inlet on administration devices (ISO
24072:2023)
Prüfverfahren für die Aerosol-Bakterienrückhaltung beim Lufteinlass an
Verabreichungsgeräten (ISO 24072:2023)
Méthode d’essai de rétention bactérienne dans les aérosols pour les filtres d'admission
d’air utilisés sur les dispositifs d’administration (ISO 24072:2023)
Ta slovenski standard je istoveten z: EN ISO 24072:2023
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 24072
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2023
EUROPÄISCHE NORM
ICS 11.040.20
English Version
Aerosol bacterial retention test method for air-inlet on
administration devices (ISO 24072:2023)
Méthode d'essai de rétention bactérienne dans les Prüfverfahren für die Aerosol-Bakterienrückhaltung
aérosols pour les filtres d'admission d'air utilisés sur beim Lufteinlass an Verabreichungsgeräten (ISO
les dispositifs d'administration (ISO 24072:2023) 24072:2023)
This European Standard was approved by CEN on 4 April 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 24072:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 24072:2023) has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical
use" in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” 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 January 2024, and conflicting national standards shall
be withdrawn at the latest by January 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/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 24072:2023 has been approved by CEN as EN ISO 24072:2023 without any modification.

INTERNATIONAL ISO
STANDARD 24072
First edition
2023-06
Aerosol bacterial retention test
method for air-inlet filter on
administration devices
Méthode d’essai de rétention bactérienne dans les aérosols pour les
filtres d'admission d’air utilisés sur les dispositifs d’administration
Reference number
ISO 24072:2023(E)
ISO 24072:2023(E)
© ISO 2023
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 24072:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 2
5 Apparatus . 2
6 Reagents and materials . 3
7 Validation of testing system .4
8 Challenge test .4
9 Assessment of results . 5
10 Report . 5
Bibliography . 6
iii
ISO 24072:2023(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 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 76, Transfusion, infusion and injection,
and blood processing equipment for medical and pharmaceutical use, in collaboration with the European
Committee for Standardization (CEN) Technical Committee CEN/TC 205, Non-active medical devices, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
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
ISO 24072:2023(E)
Introduction
Several methods are used to assess the retention ability of filter membranes, including the liquid
[1]
bacterial retention test (e.g. ASTM F838-20 ), the aerosol bacterial retention test (e.g. ASTM F2101-
[2] [3]
19 ) and the liquid virus retention test (e.g. ASTM F1671-22 ). The choice of test method depends
on the characteristics of the filtered object. For liquid filters, liquid bacteria retention test is
generally adapted. For air filters, the aerosol form of microorganisms is generally used, which is more
representative of clinical use.
Since the aerosol bacterial retention test is a destructive test with more stringent requirements for test
conditions and personnel operation, its application for routine quality controls is generally not viable.
v
INTERNATIONAL STANDARD ISO 24072:2023(E)
Aerosol bacterial retention test method for air-inlet filter
on administration devices
1 Scope
This document specifies a test method to assess bacterial retention ability of finished stand-alone and
integrated air-inlet filters on administration devices for infusion and transfusion applications.
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
aerosol
suspension of solid or liquid particles in a gas
3.2
bacterial retention ability
effectiveness of an air-inlet filter to prevent the ingress of microorganisms into the container into which
the device is inserted
3.3
collecting fluid
fluid contained in the liquid impinger that is used to collect challenge bacteria for subsequent bacteria
counting analysis
3.4
liquid impinger
glass vial used with an air sample pump to collect challenge bacteria into designated collection fluid for
analysis
Note 1 to entry: Impingers have an inlet with an internal protrusion extending close to the bottom of the vial thus
“bubbling” the sampling through the collection liquid. Air is drawn into the inlet via a port near the top of the
glass vial.
Note 2 to entry: Impingers are also known as bubblers.
3.5
sterility assurance level
probability of a single viable microorganism occurring on an item after sterilization
[SOURCE: ISO 11139:2018, 3.275, modified — Note 1 to entry has been deleted.]
...