EN ISO 22413:2021

SLOVENSKI STANDARD
01-september-2021
Nadomešča:
SIST EN ISO 22413:2013
Pribor za prenos farmacevtskih pripravkov - Zahteve in preskusne metode (ISO
22413:2021)
Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO
22413:2021)
Überleitgeräte für pharmazeutische Zubereitungen - Anforderungen und Prüfverfahren
(ISO 22413:2021)
Ensemble de transfert pour préparations pharmaceutiques - Exigences et méthodes
d'essai (ISO 22413:2021)
Ta slovenski standard je istoveten z: EN ISO 22413:2021
ICS:
11.120.99 Drugi standardi v zvezi s Other standards related to
farmacijo pharmaceutics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 22413
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2021
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 22413:2013
English Version
Transfer sets for pharmaceutical preparations -
Requirements and test methods (ISO 22413:2021)
Ensemble de transfert pour préparations Überleitgeräte für pharmazeutische Zubereitungen -
pharmaceutiques - Exigences et méthodes d'essai (ISO Anforderungen und Prüfverfahren (ISO 22413:2021)
22413:2021)
This European Standard was approved by CEN on 23 April 2021.

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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22413:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 22413:2021) 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 December 2021, and conflicting national standards
shall be withdrawn at the latest by December 2021.
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 22413:2013.
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 22413:2021 has been approved by CEN as EN ISO 22413:2021 without any modification.

INTERNATIONAL ISO
STANDARD 22413
Third edition
2021-06
Transfer sets for pharmaceutical
preparations — Requirements and
test methods
Ensemble de transfert pour préparations pharmaceutiques —
Exigences et méthodes d'essai
Reference number
ISO 22413:2021(E)
©
ISO 2021
ISO 22413:2021(E)
© 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.
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

ISO 22413:2021(E)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Design and designation . 2
4.1 Design for transfer sets without housing . 2
4.2 Design for a transfer set with housing . 5
4.3 Designation . 5
5 Materials . 5
6 Physical requirements . 5
6.1 Particulate contamination . 5
6.2 Tensile strength . 5
6.3 Leakage . 6
6.4 Free flow . 6
6.5 Piercing device . 6
6.6 Penetration force . 6
6.7 Fragmentation . 6
6.8 Air inlet and air outlet. 7
6.9 Protective caps . 7
6.10 Transfer sets with housing . 7
6.11 Small-bore connectors. 7
6.12 Fluid filter . 7
7 Chemical requirements . 7
8 Biological requirements . 7
9 Packaging . 7
10 Labelling . 8
10.1 General . 8
10.2 Unit container . 8
10.3 Shelf or multi-unit container . 8
11 Disposal . 9
Annex A (normative) Physical tests .10
Bibliography .14
ISO 22413:2021(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 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 (
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