prEN ISO 15747

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
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
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USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
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RECIPIENTS OF THIS DRAFT ARE INVITED
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NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
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
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PROVIDE SUPPORTING DOCUMENTATION.
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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 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.
NOTE Upon implementing this document, readers are encouraged to consider measures to actively reduce the use
of natural resources and minimize the ecological footprint to increase sustainability. In that respect, Annex F provides
recommendations of points to consider, from materials of construction and design, to testing strategy and sampling size.
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 2768-2, General tolerances — Part 2: Geometrical tolerances for features 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: Evaluation and testing within a risk
management process
ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
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/DIS 15747:2025(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)
3.12
sheeting
plastic material intended for the production of empty container (3.3)

ISO/DIS 15747:2025(en)
3.13
type testing
conformity testing on the basis of one or more specimens of a product representative of the production
[SOURCE: ISO/IEC Guide 2, 14.5]
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
The physical tests shall be carried out according to Annex A.
4.1.1 Manufacturing process compatibility
The infusion container shall be in accordance with the requirements given in 4.1.2 to 4.1.5 and 4.1.7 to
4.1.12 after the manufacturing process (such as sterilization).
4.1.2 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.
4.1.3 Resistance to dropping
The infusion container shall sustain no damage, nor leak, after being dropped when tested as specified in A.4.
4.1.4 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.
4.1.5 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.
4.1.6 Particulate contamination
Infusion containers shall be manufactured so that contamination with particles is avoided.
When empty infusion 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.
4.1.7 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/DIS 15747:2025(en)
4.1.8 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
rate of 500 mm·min−1, when tested as specified in A.8.
4.1.9 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.
4.1.10 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.
4.1.11 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.
4.1.12 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
The chemical tests shall be carried out according to Annex B.
4.2.1 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
[9]
be tested as described in the relevant pharmacopoeias (such as Ph. Eur. 3.1 and its sub-chapters for the
[13]
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/DIS 15747:2025(en)
4.2.2 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
[10] [11] [14]
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:
≤0,25 for infusion containers with a nominal capacity
UV absorbance B.7
≤100 ml
≤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
The biological tests shall be carried out according to Annex C.
4.3.1 Impermeability for microorganisms
The infusion container shall be impermeable to microorganisms when tested as specified in C.2.
4.3.2 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 sterilization process.
ISO/DIS 15747:2025(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
infusion solution or with water.
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.
NOTE Guidance for sampling is provided, for instance, in ISO 2859-1 for inspection by attributes or in 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, such as a
pressure cuff, is applied to the bag in order to generate an equivalent internal pressure.
The test is passed if no leakage can be determined on visual inspection. The test does not apply to the
internal seals separating chambers within a container.
For infusion containers labelled “protect from freezing”, omit storage at −25 °C.
A.4 Resistance to dropping
Drop the infusion containers on a hard, rigid, smooth surface at a temperature of (20 to 30) °C. Determine
the height of drop in accordance with Table A.1, depending upon the nominal capacity of the infusion
container.
The test is passed if both:
— the infusion container is not broken, and
— no leakage can be determined on visual inspection.
Table A.1 — Height of drop depending upon nominal capacity
Nominal capacity Height of drop
ml m
50 to 749 1,00
750 to 1 499 0,75
1 500 to 2 499 0,50
2 500 and above 0,25
ISO/DIS 15747:2025(en)
A.5 Transparency
Prepare a stem suspension as follows.
a) Dissolve 6,0 g hydrazine sulphate for analysis in 400 ml clear water.
b) Dissolve 60,0 g hexamethylenetetramine for analysis in 400 ml clear water.
c) The two solutions are poured consecutively into a 1 l measuring flask, filled to 1 l with clear water.
d) Leave the solution to stand for 48 h at (20 to 30) °C so that a formazine suspension can develop.
Dilute the stem suspension according to a) to d) 1:100. Fill an empty infusion container to nominal
capacit
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