oSIST prEN ISO 15747:2025
(Main)Plastic containers for intravenous injections (ISO/DIS 15747:2025)
Plastic containers for intravenous injections (ISO/DIS 15747:2025)
This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.
This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.
NOTE In some countries, national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this document.
Kunststoffbehältnisse für intravenöse Injektionen (ISO/DIS 15747:2025)
Récipients en plastique pour injections intraveineuses (ISO/DIS 15747:2025)
Le présent document spécifie les exigences relatives à la manipulation sûre et aux essais physiques, chimiques et biologiques des récipients en plastique pour préparations parentérales.
Le présent document s'applique aux récipients en plastique pour préparations parentérales, munis d'un ou de plusieurs compartiments et ayant une capacité nominale totale comprise entre 50 ml et 5 000 ml, tels que les poches souples en feuille de polymère ou les flacons en plastique extrudé-soufflé pour l'administration directe en perfusion (injection) des solutions.
NOTE Dans certains pays, la pharmacopée nationale ou régionale ou autres réglementations gouvernementales ont force de loi et ces exigences ont priorité sur le présent document.
Plastični zbiralniki za intravenske injekcije (ISO/DIS 15747:2025)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2025
Plastični zbiralniki za intravenske injekcije (ISO/DIS 15747:2025)
Plastic containers for intravenous injections (ISO/DIS 15747:2025)
Kunststoffbehältnisse für intravenöse Injektionen (ISO/DIS 15747:2025)
Récipients en plastique pour injections intraveineuses (ISO/DIS 15747:2025)
Ta slovenski standard je istoveten z: prEN ISO 15747
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.
DRAFT
International
Standard
ISO/DIS 15747
ISO/TC 76
Plastic containers for intravenous
Secretariat: DIN
injections
Voting begins on:
Récipients en plastique pour injections intraveineuses
2025-05-12
Voting terminates on:
ICS: 11.040.20
2025-08-04
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
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This document is circulated as received from the committee secretariat.
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RIGHTS OF WHICH THEY ARE AWARE AND TO
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Reference number
ISO/DIS 15747:2025(en)
DRAFT
ISO/DIS 15747:2025(en)
International
Standard
ISO/DIS 15747
ISO/TC 76
Plastic containers for intravenous
Secretariat: DIN
injections
Voting begins on:
Récipients en plastique pour injections intraveineuses
ICS: 11.040.20 Voting terminates on:
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
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TO SUBMIT, WITH THEIR COMMENTS,
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NOTIFICATION OF ANY RELEVANT PATENT
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Published in Switzerland Reference number
ISO/DIS 15747:2025(en)
ii
ISO/DIS 15747:2025(en)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirement . 3
4.1 Physical requirements .3
4.1.1 Manufacturing process compatibility .3
4.1.2 Resistance to temperature, pressure and leakage .3
4.1.3 Resistance to dropping .3
4.1.4 Transparency . . .3
4.1.5 Water vapour permeability .3
4.1.6 Particulate contamination .3
4.1.7 Cover .3
4.1.8 Access port — Penetration ability of the insertion point .4
4.1.9 Access port — Adhesion strength of the infusion device and impermeability of
the insertion point .4
4.1.10 Access port — Tightness of the injection point .4
4.1.11 Hanger.4
4.1.12 Identification .4
4.2 Chemical requirements . .4
4.2.1 Requirements for the raw container or the sheeting .4
4.2.2 Requirements for the test fluid .5
4.3 Biological requirements .5
4.3.1 Impermeability for microorganisms .5
4.3.2 Migration .5
5 Application of tests . 5
Annex A (normative) Physical tests . . 6
Annex B (normative) Chemical tests . 9
Annex C (normative) Biological tests .12
Annex D (normative) Reference spike . 14
Annex E (informative) Rationale, guidance and history of the development the standard .15
Annex F (informative) Sustainability .18
Annex G (informative) Attribute testing . 19
Bibliography .20
iii
ISO/DIS 15747:2025(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 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).
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.
This fourth edition cancels and replaces the third edition (ISO 15747:2018), which has been technically
revised.
The main changes are as follows:
— The term “cannula” has been replaced by the better suited term “needle” throughout the document. Per
common understanding, cannulas are flexible, while needles, such as 23G needles called for in A.10, as
well as other so-called “transfer needles/devices” used to add medication through an injection point,
whether they are sharp or blunt, need to be rigid to pierce said injection port and are typically made of
stainless steel or moulded thermoplastic.
— Alignment of the introductory text of 5.1, 5.2 and 5.3 to highlight the normative nature of the introductory
clauses A.1, A.2, B.1 and C.1, as they contain important information to properly conduct the tests. Those
clauses were not directly called in by any requirement since they don’t describe test methods related to
said requirements.
— Usage of terms “procedure” and “method” clarified: “method” now used as way to perform a test, while
“procedure” denotes a process to reach a certain state (e.g. thinking process or working process).
— Addition of a new Annex E Rationale and guidance, to provide explanations about the history of the
development of the standard and to summarize the different arguments discussed within ISO/TC76
during the elaboration of the document.
— Addition of a new Annex F Sustainability and a new Annex G Attribute testing.
— Addition of references to pharmacopoeias pertaining to chemical requirements, in 4.2.1 and 4.2.2.
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
DRAFT International Standard ISO/DIS 15747:2025(en)
Plastic containers for intravenous injections
1 Scope
This document specifies requirements to the safe handling and the physical, chemical and biological testing
of plastic
...
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