SIST EN ISO 15747:2026

Plastic containers for intravenous injections (ISO 15747:2026)

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 1        In some countries, national or regional pharmacopoeias or other government regulations are legally binding, and these requirements take precedence over this document.
NOTE 2        Annex E provides explanations about the history of the development of the standard and summarises the different arguments discussed within ISO/TC 76 during the elaboration of the document.
NOTE 3        Annex F provides recommendations regarding sustainability.
NOTE 4        Annex G provides information on attributive and variable testing.

Kunststoffbehältnisse für intravenöse Injektionen (ISO 15747:2026)

Dieses Dokument legt Anforderungen zur sicheren Handhabung sowie die physikalische, chemische und biologische Prüfung von Kunststoffbehältnissen für parenterale Injektionen fest.
Dieses Dokument gilt für Kunststoffbehältnisse für parenterale Injektionen mit einer oder mehreren Kammern und einer Gesamt-Nennfüllmenge zwischen 50 ml und 5 000 ml, wie Beutel aus Folie oder durch Spritzguss gefertigte Flaschen aus Kunststoff für Lösungen zur direkten Infusion (Injektion).
ANMERKUNG 1   In einigen Ländern sind nationale oder regionale Arzneibücher oder sonstige staatliche Vorschriften rechtsverbindlich und deren Anforderungen haben Vorrang gegenüber diesem Dokument.
ANMERKUNG 2   Anhang E enthält Erläuterungen zum Entwicklungsgang der Norm sowie eine zusammenfassende Darstellung der verschiedenen während der Erarbeitung des Dokuments in ISO/TC 76 erörterten Argumente.
ANMERKUNG 3   Anhang F gibt Empfehlungen hinsichtlich der Nachhaltigkeit.
ANMERKUNG 4   Anhang G stellt Informationen zur Prüfung attributiver und variabler Merkmale bereit.

Récipients en plastique pour injections intraveineuses (ISO 15747:2026)

Le présent document spécifie les exigences relatives à la manipulation en toute sécurité et aux essais physiques, chimiques et biologiques des récipients en plastique pour administration parentérale.
Le présent document est applicable aux récipients en plastique pour administration parentérale comportant une ou plusieurs chambres et ayant une capacité nominale totale comprise entre 50 ml et 5 000 ml, tels que les sacs en film ou les flacons en plastique moulés par soufflage pour l’administration directe de solutions pour perfusion (injection).
NOTE 1        Dans certains pays, les pharmacopées nationales ou régionales ou d'autres réglementations gouvernementales sont juridiquement contraignantes, et ces exigences prévalent sur le présent document.
NOTE 2        L'Annexe E fournit des explications sur l'historique de l'élaboration de la norme et résume les différents arguments discutés au sein de l'ISO/TC 76 lors de l'élaboration du document.
NOTE 3        L'Annexe F fournit des recommandations concernant la durabilité.
NOTE 4        L'Annexe G fournit des informations sur les essais par attributs et par mesures.

Plastične posode za intravenske injekcije (ISO 15747:2026)

Ta dokument določa zahteve za varno ravnanje ter fizikalno, kemijsko in biološko testiranje plastičnih posod za parenteralno uporabo.
Ta dokument se uporablja za plastične posode za parenteralno uporabo z eno ali več komorami in s skupno nazivno prostornino v razponu od 50 ml do 5 000 ml, kot so filmske vrečke ali plastične steklenice, izdelane s pihanjem, za neposredno dajanje infuzijskih (injekcijskih) raztopin.
OPOMBA 1 V nekaterih državah so nacionalne ali regionalne farmakopeje ali drugi vladni predpisi pravno zavezujoči in te zahteve imajo prednost pred tem dokumentom.
OPOMBA 2 Dodatek E vsebuje pojasnila o zgodovini razvoja standarda in povzema različne argumente, ki so bili obravnavani v okviru ISO/TC 76 med pripravo dokumenta.
OPOMBA 3 Dodatek F vsebuje priporočila glede trajnosti.
OPOMBA 4 Dodatek G vsebuje informacije o atributivnem in spremenljivem testiranju.

General Information

• Status: Published
• Public Enquiry End Date: 30-Jul-2025
• Publication Date: 10-Jun-2026
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 28-May-2026
• Due Date: 02-Aug-2026
• Completion Date: 11-Jun-2026
• Ref Project: EN ISO 15747:2026 - Plastic containers for intravenous injections (ISO 15747:2026)

Relations

• Replaces: SIST EN ISO 15747:2019 - Plastic containers for intravenous injections (ISO 15747:2018)
• Effective Date: 01-Jul-2026

Overview

SIST EN ISO 15747:2026 - Plastic containers for intravenous injections (ISO 15747:2026) - is an international standard that specifies requirements for safe handling, as well as physical, chemical, and biological testing of plastic containers intended for parenteral solutions. This standard covers plastic containers such as film bags and blow-moulded plastic bottles, with one or more chambers and nominal capacities ranging from 50 ml to 5,000 ml, used for direct administration of infusion or injection solutions. It aims to ensure the safety, performance, and compatibility of containers used in medical infusion applications.

Key Topics

• Safe Handling: The standard mandates procedures and requirements for ensuring safe handling of plastic containers, minimizing risks during storage, transport, and use.
• Physical Testing: Requirements address durability (resistance to temperature, pressure, leakage, and dropping), transparency, water vapour permeability, particulate contamination, and integrity of access ports and hangers.
• Chemical Testing: Guidelines cover testing raw container materials and test fluids for chemical residues, metallic content, UV absorbance, acidity or alkalinity, and other attributes, aligning with relevant pharmacopoeias.
• Biological Testing: Procedures ensure materials are impermeable to microorganisms and prevent the migration of harmful substances, ensuring patient safety.
• Identification and Labelling: Containers must have legible, durable identification to ensure traceability and safe product use.
• Sustainability Considerations: The standard references best practices for sustainable design, material selection, and disposal, outlined in the informative annexes.
• Testing Methodology: Differentiates between type testing (for initial qualification or significant changes) and batch testing, ensuring consistency and compliance.

Applications

Plastic containers for infusion and injection solutions are crucial across healthcare settings, including:

• Hospitals and Clinics: Used for the direct administration of intravenous fluids and medications, ensuring sterility and dosage accuracy.
• Pharmaceutical Manufacturing: Standardized testing facilitates quality assurance and regulatory compliance for infusion container production.
• Transportation and Distribution: Robust physical requirements reduce the risk of breakage or leakage during shipment.
• Disaster Response and Field Medicine: Durable containers support safe parenteral administration in challenging environments.
• Regulatory Compliance: Aligning with ISO 15747 supports manufacturers and healthcare providers in meeting both international standards and national regulations, especially where pharmacopoeias apply.

Related Standards

• ISO 8536-4: Infusion equipment for medical use - infusion sets for single use, gravity feed.
• ISO 10993-1 / ISO 10993-5: Biological evaluation and cytotoxicity testing for medical devices.
• ISO 2768-1 / ISO 2768-2: General tolerances for linear, angular, and geometrical dimensions.
• Pharmacopoeial Standards: European Pharmacopoeia (Ph. Eur.), United States Pharmacopeia (USP) for chemical and material tests.
• ISO 2859-1 / ISO 3951-1: Guidelines for inspection by attributes and variables in quality control.

Practical Value

By adhering to SIST EN ISO 15747:2026, manufacturers and healthcare providers can:

• Enhance patient safety by using rigorously tested, contamination-free intravenous containers.
• Streamline manufacturing and quality control processes with clearly defined test methods and acceptance criteria.
• Demonstrate compliance with international and national healthcare regulations.
• Contribute to sustainability goals by applying recommended ecological practices during design, production, and disposal.

Implementing this standard supports reliable, high-quality intravenous treatment delivery and aligns with evolving industry and regulatory expectations.

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2026
Nadomešča:
SIST EN ISO 15747:2019
Plastični zbiralniki za intravenske injekcije (ISO 15747:2026)
Plastic containers for intravenous injections (ISO 15747:2026)
Kunststoffbehältnisse für intravenöse Injektionen (ISO 15747:2026)
Récipients en plastique pour injections intraveineuses (ISO 15747:2026)
Ta slovenski standard je istoveten z: EN ISO 15747:2026
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 15747
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2026
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 15747:2019
English Version
Plastic containers for intravenous injections (ISO
15747:2026)
Récipients en plastique pour injections intraveineuses Kunststoffbehältnisse für intravenöse Injektionen (ISO
(ISO 15747:2026) 15747:2026)
This European Standard was approved by CEN on 28 April 2026.

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
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15747:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 15747:2026) 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 November 2026, and conflicting national standards
shall be withdrawn at the latest by November 2026.
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 15747:2019.
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 15747:2026 has been approved by CEN as EN ISO 15747:2026 without any modification.

International
Standard
ISO 15747
Fourth edition
Plastic containers for intravenous
2026-05
injections
Récipients en plastique pour injections intraveineuses
Reference number
ISO 15747:2026(en) © ISO 2026
ISO 15747:2026(en)
© ISO 2026
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 15747:2026(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 General .3
4.1.2 Manufacturing process compatibility .3
4.1.3 Resistance to temperature, pressure and leakage .3
4.1.4 Resistance to dropping .3
4.1.5 Transparency . . .3
4.1.6 Water vapour permeability .3
4.1.7 Particulate contamination .3
4.1.8 Cover .3
4.1.9 Access port — Penetration ability of the insertion point .4
4.1.10 Access port — Adhesion strength of the infusion device and impermeability of
the insertion point .4
4.1.11 Access port — Tightness of the injection point .4
4.1.12 Hanger.4
4.1.13 Identification .4
4.2 Chemical requirements . .4
4.2.1 General .4
4.2.2 Requirements for the raw container or the sheeting .4
4.2.3 Requirements for the test fluid .5
4.3 Biological requirements .5
4.3.1 General .5
4.3.2 Impermeability for microorganisms .5
4.3.3 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 of this document .16
Annex F (informative) Sustainability . 19
Annex G (informative) Attributive and variable testing .21
Bibliography .22

iii
ISO 15747:2026(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 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).
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.
— Addition of subclauses 4.1.1, 4.2.1 and 4.3.1 to highlight the normative nature of the introductory
subclauses A.1, A.2, B.1 and C.1, as they contain important information to properly conduct the tests.
Those introductory clauses were not directly referenced in any requirement since they don’t describe
test methods related to said requirements. Addition of those three subclauses led to the renumbering of
all other subclauses of Clause 4.
— 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/TC 76
during the elaboration of the document.
— Addition of a new Annex F (Sustainability) and a new Annex G (Attributive and variable testing).
— Addition of references to pharmacopoeias pertaining to chemical requirements, in 4.2.

iv
ISO 15747:2026(en)
— Replacement of reference to ISO 2768-2 (withdrawn) by ISO 22081 in Figure D.1, Annex D and Clause 2.
Consequently, Figure D.1 has been modified (addition of reference datums, etc.)
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.

v
International Standard ISO 15747:2026(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 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 1 In some countries, national or regional pharmacopoeias or other government regulations are legally
binding, and these requirements take precedence over this document.
NOTE 2 Annex E provides explanations about the history of the development of the standard and summarises the
different arguments discussed within ISO/TC 76 during the elaboration of the document.
NOTE 3 Annex F provides recommendations regarding sustainability.
NOTE 4 Annex G provides information on attributive and variable testing.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 2768-1, General tolerances — Part 1: Tolerances for linear and angular dimensions without individual
tolerance indications
ISO 8536-4, Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
ISO 10993-1, Biological evaluation of medical devices — Part 1: Requirements and general principles for the
evaluation of biological safety within a risk management process
ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
ISO 15510, Stainless steels — Chemical composition
ISO 22081, Geometrical product specifications (GPS) — Geometrical tolerancing — General geometrical
specifications and general size specifications
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
access port
area of the infusion container (3.7) consisting of the insertion point (3.9) and the injection point (3.8), if
applicable
ISO 15747:2026(en)
3.2
cover
part that protects an access port (3.1) during storage and before use
Note 1 to entry: The cover can also envelop the entire container (e.g. outer bag).
3.3
empty container
raw container (3.11) with identification (3.6), which is suitable for the acceptance, storage and administration
of the injection solution
3.4
gauge pressure
pressure zero-referenced against local atmospheric pressure
Note 1 to entry: Container internal gauge pressure is:
— positive when the container is pressurized above the surrounding atmospheric pressure, and is
— negative when the container is subjected to suction.
3.5
hanger
part of the container that is used to hang it up
3.6
identification
paper label, foil label, printing or embossing used to identify the product
3.7
infusion container
container filled to its nominal capacity (3.10) with parenteral injection product and with identification (3.6)
for the storage and administration of the parenteral injection product
3.8
injection point
point where pharmaceuticals are injected
Note 1 to entry: The injection point and the insertion point can be identical.
Note 2 to entry: Some containers intentionally do not have an injection point.
3.9
insertion point
point which accepts the insertion part of the infusion device
3.10
nominal capacity
intended or declared fluid volume of a container
3.11
raw container
empty container (3.3) that has not yet been sterilized and has no identification (3.6) other than eventual
embossing
3.12
sheeting
plastic material intended for the production of empty container (3.3)

ISO 15747:2026(en)
3.13
type testing
conformity testing on the basis of one or more specimens of a product representative of the production
Note 1 to entry: type tests are carried out to demonstrate conformity with the requirements of this document and/or
when a significant change is made in the product design, materials and/or method of manufacture, the effects of which
cannot be predicted based on previous experience (see Clause 5).
4 Requirement
4.1 Physical requirements
4.1.1 General
The physical tests shall be carried out according to Annex A.
4.1.2 Manufacturing process compatibility
The infusion container shall be in accordance with the requirements given in 4.1.3 to 4.1.6 and 4.1.8 to 4.1.13
after the manufacturing process (such as sterilisation).
4.1.3 Resistance to temperature, pressure and leakage
The infusion container shall withstand alternating thermal stress, shall be resistant to pressure and shall be
leak-free when tested as specified in A.3.
4.1.4 Resistance to dropping
The infusion container shall sustain no damage, nor leak, after being dropped when tested as specified in
A.4.
4.1.5 Transparency
The infusion container shall be sufficiently transparent so that suspended particles, turbidity and
discoloration can be recognised when tested as specified in A.5.
4.1.6 Water vapour permeability
Unless otherwise defined for specific applications or uses, the packed infusion solution shall not lose more
than 5 % of its mass during the period of usability, when tested as specified in A.6.
4.1.7 Particulate contamination
Infusion containers shall be manufactured so that contamination with particles is avoided.
When empty containers are tested as specified in A.7, no more than 25 particles with a diameter ≥10 µm and
no more than 3 particles with a diameter ≥25 µm shall be found per millilitre of nominal capacity. Finished
parenteral solutions in the infusion containers shall be in accordance with relevant pharmacopoeial
requirements for particulate matter in finished products.
4.1.8 Cover
The access port shall be protected by a cover. Its intactness is determined by visual inspection. It shall be
possible to remove the cover without using mechanical aids.

ISO 15747:2026(en)
4.1.9 Access port — Penetration ability of the insertion point
It shall be possible to pierce the insertion point with the insertion part of an infusion device as specified in
ISO 8536-4 or of a reference spike as described in Annex D. The force shall not exceed 200 N at an insertion
−1
rate of 500 mm·min , when tested as specified in A.8.
4.1.10 Access port — Adhesion strength of the infusion device and impermeability of the insertion
point
The material and design of the access port shall be suitable for accepting the insertion part of an infusion
device in accordance with ISO 8536-4 or of a reference spike as described in Annex D, for sealing off the
insertion point and for holding the insertion part firmly when subject to tensile load. When tested as
specified in A.9, no leakage shall occur, and the insertion part shall not slide out from the insertion point.
The removal force shall be greater than 15 N.
The packed infusion solution and used spike can affect the results of the test and should be considered
during the testing.
4.1.11 Access port — Tightness of the injection point
If the container has an injection point, this shall not leak after puncturing and removal of the needle when
tested as specified in A.10.
Diameter of needles used in the field to add pharmaceuticals in a liquid form into an IV container can differ
from that specified in A.10, for instance to make transfer of viscous drugs easier and faster. Results obtained
when applying the specified test method provide benchmark to evaluate injection point performance.
However, they do not necessarily reflect the product performance in the intended use.
4.1.12 Hanger
It shall be possible to hang the infusion container up when it is in use. The hanger shall withstand a tensile
load when tested as specified in A.11.
4.1.13 Identification
The identification characters shall be clearly legible, and affixed labels shall not become detached when
tested as specified in A.12.
4.2 Chemical requirements
4.2.1 General
The chemical tests shall be carried out according to Annex B.
4.2.2 Requirements for the raw container or the sheeting
The raw container or the sheeting shall fulfil the requirements given in Table 1. Alternatively, it may be
[10]
tested as described in the relevant pharmacopoeias (such as Ph. Eur. 3.1 and its sub-chapters for the
[14]
different materials used, or USP<661.1> ).
Table 1 — Requirements for the raw container or the sheeting
Requirements Maximum permissible value Test as specified in
Residue on ignition:
—  polyolefin 5 mg/g B.2
—  polyvinyl chloride, containing plasticizers 1 mg/g
—  Metals: Ba, Cd, Cr, Cu, Pb, Sn for each metal, 3 mg/kg B.3

ISO 15747:2026(en)
4.2.3 Requirements for the test fluid
The test fluid shall be prepared as specified in B.4. No coloration, but weak opalescence of the test fluid, is
permissible. It shall fulfil the requirements specified in Table 2. Alternatively, it may be tested as described
[11] [12] [15]
in the relevant pharmacopoeias (such as Ph. Eur. 3.2.2 , Ph. Eur. 3.2.2.1 , or USP<661.2> ).
Table 2 — Requirements for the test fluid
Requirements Maximum permissible value Test as specified in
0,4 ml sodium hydroxide solution
[c(NaOH) = 0,01 mol/l]
Acidity or alkalinity B.6
0,8 ml hydrochloric acid
[c(HCl) = 0,01 mol/l]
in the range of 230 nm to 360 nm:
UV absorbance ≤0,25 for infusion containers with a nominal capacity ≤100 ml B.7
≤0,2 for infusion containers with a nominal capacity >100 ml
Evaporation residue 5 mg B.8
Oxidizable constituents 1,5 ml B.9
Ammonia 0,8 mg/l B.10
Metals:
Ba, Cr, Cu, Pb for each metal, 1 mg/l
B.11
Sn, Cd for each metal, 0,1 mg/l
Al 0,05 mg/l
Heavy metals 2 mg/l B.12
4.3 Biological requirements
4.3.1 General
The biological tests shall be carried out according to Annex C.
4.3.2 Impermeability for microorganisms
The infusion container shall be impermeable to microorganisms when tested as specified in C.2.
4.3.3 Migration
The materials used for the manufacture of infusion containers (e.g. films, wrappings, adhesives, adhesion
promoters, printing inks) shall not release any substances into the infusion solution in such quantities that
they have a pyrogenic or toxic effect when tested as specified in C.3, C.4 and ISO 10993-1.
5 Application of tests
A distinction is made between type testing and batch testing. All tests specified in Annexes A to C are type
testing. They shall be repeated if one or more of the following conditions is changed significantly so that the
requirements as specified in Clause 4 might be affected:
— the design;
— the plastic composition;
— the process of manufacturing the infusion container;
— the sterilisation process.
ISO 15747:2026(en)
Annex A
(normative)
Physical tests
A.1 General
Physical testing shall be performed using an infusion container filled up to the nominal capacity with
representative solution.
NOTE For tests A.8, A.9 and A.10 pertaining to the performances of the access port(s), the nature of the solution
intended to be marketed in the infusion container can affect the results of the tests, e.g. viscous or lubricious solution
such as fat emulsion. Therefore, aqueous solutions can not be considered representative solutions.
A.2 Sampling
Take samples required for the tests specified in A.3 to A.12 in accordance with the requirements of statistical
quality control for sampling for the type test.
[2]
NOTE Guidance for sampling is provided, for instance, in ISO 2859-1 for inspection by attributes or in
[4]
ISO 3951-1 for inspection by variables.
A.3 Resistance to temperature, pressure and leakage
Store infusion containers for 24 h at (−25 ± 5) °C and subsequently for 24 h at (50 ± 5) °C, and then subject
them to an internal gauge pressure of 50 kPa between two plane parallel plates at (20 to 30) °C. Maintain
this pressure for 15 min. An equivalent test method may be used in which an external pressure is appl
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