SIST EN ISO 24072:2023
(Main)Aerosol bacterial retention test method for air-inlet on administration devices (ISO 24072:2023)
Aerosol bacterial retention test method for air-inlet on administration devices (ISO 24072:2023)
This document specifies a test method which is applicable for the assessment on bacterial retention ability of finished air-inlet filters for infusion and transfusion sets as well as transfer devices.
Assessment on bacterial retention ability of air filtration membrane materials for infusion and transfusion sets as well as transfer devices may refer to this document.
Prüfverfahren für die Aerosol-Bakterienrückhaltung beim Lufteinlass an Verabreichungsgeräten (ISO 24072:2023)
Dieses Dokument legt ein Prüfverfahren für die Bewertung der Bakterienrückhaltefähigkeit von fertigen Belüftungsfiltern (aller Porengrößen) für Verabreichungsgeräte, z. B. medizinische Infusions- und Transfusionsvorrichtungen, fest.
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
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 24072:2023
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
SIST EN ISO 24072:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 24072:2023
---------------------- Page: 2 ----------------------
SIST EN ISO 24072:2023
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 24072:2023
EN ISO 24072:2023 (E)
Contents Page
European foreword . 3
2
---------------------- Page: 4 ----------------------
SIST EN ISO 24072:2023
EN ISO 24072:2023 (E)
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.
3
----
...
SLOVENSKI STANDARD
oSIST prEN ISO 24072:2022
01-februar-2022
Preskusna metoda za zadrževanje bakterij v aerosolu pri napravah za vnos zraka
(ISO/DIS 24072:2021)
Aerosol bacterial retention test method for air-inlet on administration devices (ISO/DIS
24072:2021)
Prüfverfahren für die Aerosol-Bakterienrückhaltung beim Lufteinlass an
Verabreichungsgeräten (ISO/DIS 24072:2021)
Méthode d’essai de rétention bactérienne dans les aérosols pour l’admission d’air sur les
dispositifs d’administration (ISO/DIS 24072:2021)
Ta slovenski standard je istoveten z: prEN ISO 24072
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
oSIST prEN ISO 24072:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 24072:2022
---------------------- Page: 2 ----------------------
oSIST prEN ISO 24072:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 24072
ISO/TC 76 Secretariat: DIN
Voting begins on: Voting terminates on:
2021-12-24 2022-03-18
Aerosol bacterial retention test method for air-inlet on
administration devices
ICS: 11.040.20
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 24072:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2021
---------------------- Page: 3 ----------------------
oSIST prEN ISO 24072:2022
ISO/DIS 24072:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
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 2021 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 24072:2022
ISO/DIS 24072:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Test system .1
4.1 Overview . 1
4.2 Aerosol generator . 2
4.3 Aerosol chamber . 2
4.4 Sample challenging sets .
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.