EN ISO 24072:2023

Aerosol bacterial retention test method for air-inlet on administration devices (ISO 24072:2023)

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.

Prüfverfahren für die Aerosol-Bakterienrückhaltung beim Lufteinlass an Verabreichungsgeräten (ISO 24072:2023)

Dieses Dokument legt ein Prüfverfahren fest, um die Bakterienrückhaltefähigkeit von fertigen eigenständigen und integrierten Belüftungsfiltern auf Verabreichungsgeräten für medizinische Infusions- und Transfusionsvorrichtungen zu beurteilen.

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)

Le présent document spécifie une méthode d’essai pour évaluer la capacité de rétention bactérienne des filtres d’admission d’air finis, indépendants et intégrés, utilisés sur les dispositifs d’administration employés dans le cadre d’applications de perfusion et de transfusion.

Preskusna metoda za zadrževanje bakterij v aerosolu pri napravah za vnos zraka (ISO 24072:2023)

Ta dokument določa preskusno metodo, ki se uporablja za ocenjevanje sposobnosti zadrževanja bakterij končnih filtrov naprav za vnos zraka pri kompletih za infuzijo in transfuzijo ter pripomočkih za prenos.
Ocena sposobnosti zadrževanja bakterij membranskih materialov za filtriranje zraka pri kompletih za infuzijo in transfuzijo ter pripomočkih za prenos se lahko nanaša na ta dokument.

General Information

• Status: Published
• Publication Date: 04-Jul-2023
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 05-Jul-2023
• Due Date: 30-Jun-2024
• Completion Date: 05-Jul-2023
• Ref Project: SIST EN ISO 24072:2023 - Aerosol bacterial retention test method for air-inlet on administration devices (ISO 24072:2023)

Overview

EN ISO 24072:2023 (ISO 24072:2023) specifies an aerosol bacterial retention test method for assessing the bacterial retention ability of finished stand‑alone and integrated air‑inlet filters used on administration devices for infusion and transfusion. The method simulates a clinical aerosol challenge using a Staphylococcus aureus aerosol to quantify how many microorganisms can pass through an air‑inlet filter under defined, more stringent conditions than normal clinical use.

Key topics and technical requirements

• Test principle: Challenge with a Staphylococcus aureus aerosol and measure bacteria passing through the air‑inlet filter using liquid impingers and colony counting.
• Aerosol characteristics: Aerosol generator calibrated to produce a mass median aerodynamic diameter (MMAD) of (2.5 ± 0.5) μm with a geometric standard deviation (GSD) ≈ 1.8.
• Challenge organism and preparation: Staphylococcus aureus ATCC 6538™ (or equivalent), incubated in TSB/NB at (32.5 ± 2.5) °C for 18–24 h and diluted to validated concentration.
• Apparatus: Aerosol generator and chamber, sample test housing (designed for stand‑alone or integrated filters), liquid impingers with collecting fluid (sterile saline), flowmeter and vacuum pump.
• Flow conditions: Test flow set and controlled at 50 ml/min (flowmeter accuracy ±5 %) to simulate and exceed infusion‑device air throughput.
• Analytical materials: Tryptone Soya Broth/Agar or Nutrient Broth/Agar for enrichment and counting; analytical filter membrane nominal pore size 0.45 μm.
• Validation and controls: System validation on first use (challenge concentration, spraying time, sampling) and positive control pipeline for comparison.
• Outcome and assessment: Quantify bacteria collected downstream to calculate bacterial retention ability. The method is intentionally more stringent than clinical exposure and is generally destructive, making it unsuitable for routine quality control.

Practical applications and users

Who uses EN ISO 24072:2023:

• Medical device manufacturers designing or validating administration devices (infusion sets, transfusion connectors) with air‑inlet filters.
• Contract testing laboratories performing pre‑market verification, product qualification, or failure analysis.
• Regulatory and quality assurance teams requiring standardized evidence of microbial barrier performance.
• R&D teams optimizing filter materials, housing designs, or claims for sterility assurance level.

Typical uses:

• Pre‑market performance testing and design verification
• Comparative testing between filter designs or materials
• Root‑cause analysis when microbial ingress is suspected

Related standards

• ISO 8536‑4 (examples of air‑inlet filter assemblies referenced)
• ISO 11139 (sterility terminology)
• Other bacterial/viral retention test methods (e.g., liquid and aerosol tests such as ASTM F838, ASTM F2101, ASTM F1671) for complementary assessments

Keywords: EN ISO 24072:2023, ISO 24072, aerosol bacterial retention test, air‑inlet filter, administration devices, infusion, transfusion, Staphylococcus aureus, liquid impinger, MMAD, bacterial retention ability.

Standards Content (Sample)

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: [phone]
Email: [e-mail]
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
SIST EN ISO 24
...