SIST EN ISO 15747:2019

SLOVENSKI STANDARD
SIST EN ISO 15747:2019
01-maj-2019
1DGRPHãþD
SIST EN ISO 15747:2012
3ODVWLþQL]ELUDOQLNL]DLQWUDYHQVNHLQMHNFLMH,62
Plastic containers for intravenous injections (ISO 15747:2018)
Kunststoffbehältnisse für intravenöse Injektionen (ISO 15747:2018)
Récipients en plastique pour injections intraveineuses (ISO 15747:2018)
Ta slovenski standard je istoveten z: EN ISO 15747:2019
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 15747:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15747:2019

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SIST EN ISO 15747:2019


EN ISO 15747
EUROPEAN STANDARD

NORME EUROPÉENNE

March 2019
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 15747:2011
English Version

Plastic containers for intravenous injections (ISO
15747:2018)
Récipients en plastique pour injections intraveineuses Kunststoffbehältnisse für intravenöse Injektionen (ISO
(ISO 15747:2018) 15747:2018)
This European Standard was approved by CEN on 28 February 2019.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15747:2019 E
worldwide for CEN national Members.

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SIST EN ISO 15747:2019
EN ISO 15747:2019 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 5

2

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SIST EN ISO 15747:2019
EN ISO 15747:2019 (E)
European foreword
This document (EN ISO 15747:2019) 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 CCMC.
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 September 2019, and conflicting national standards
shall be withdrawn at the latest by September 2019.
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 15747:2011.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive(s) see informative Annex ZA, which is an integral part of this
document.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard “within the
meaning of Annex ZA”, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated ISO or
IEC standard, as listed below.
NOTE The way in which these references documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table — Correlations between normative references and dated EN and ISO standards
Equivalent dated standard
Normative references as listed in
Clause 2 of the ISO standard
EN ISO or IEC
ISO 2768-1 — ISO 2768-1:1989
ISO 2768-2 — ISO 2768-2:1989
ISO 8536-4 EN ISO 8536-4:2013 + ISO 8536-4:2010 +
A1:2013 Amd 1:2013
ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009
ISO 10993-5 EN ISO 10993-5:2009 ISO 10993-5:2009

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SIST EN ISO 15747:2019
EN ISO 15747:2019 (E)
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 15747:2018 has been approved by CEN as EN ISO 15747:2019 without any modification.

4

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SIST EN ISO 15747:2019
EN ISO 15747:2019 (E)
Annex ZA
(informative)

Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
This European Standard has been prepared under a Commission's standardization request [M/295
concerning the development of European Standards related to medical devices] to provide one
voluntary means of conforming to essential requirements of Directive 93/42/EEC of 14 June 1993
concerning medical devices [OJ L 169]
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding essential requirements
of that Directive and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This
means that risks have to be reduced “as far as possible”, “to a minimum”, “to the lowest possible level”,
“minimized” or “removed”, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Annex I of Directive
93/42/EEC [OJ L 169]
Essential Requirements of Clause(s)/subclause(s) of this
Remarks/Notes
Directive 93/42/EEC EN
7.2 4.1.6, 4.2 The part of ER 7.2 relating to
packaging is not addressed.
4.1.6 covers ER 7.2 only in
respect of particulate
contamination.
4.2 covers ER 7.2 only in respect
of the substances specified in the
Standard.
7.3 4.1.5, 4.2 Only the first half sentence of ER
7.3 is addressed.
4.1.5 covers ER 7.3 first part only
in respect of water permeability.
4.2 covers ER 7.3 first part only
in respect of the substances
specified in the Standard.
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SIST EN ISO 15747:2019
EN ISO 15747:2019 (E)
7.5 4.1.5, 4.2, 4.3.2 Only the first sentence of ER 7.5
is covered.
4.1.5 covers ER 7.5 first
sentence, first paragraph only in
respect of water permeability.
4.2 covers ER 7.5 first sentence,
first paragraph only in respect of
the substances specified in the
Standard.
4.3.2 covers ER 7.5 first
sentence, first paragraph only in
respect of the substances that
may have a pyrogenic effect.
7.6 4.1.7, 4.3.1 4.1.7 covers ER 7.6 only in
respect of preventing the ingress
of substances to the access port.
8.1 4.1.7 to 4.1.10, 4.3.1 4.1.7 covers ER 8.1 only in
respect of preventing the ingress
of substances to the access port.
4.3.1 covers ER 8.1 only in
respect of impermeability for
microorganisms into the
infusion container.
9.1 4.1.7 to 4.1.11 Restrictions indicated on the
label or in the instructions for
use are not addressed.
4.1.7 covers ER 9.1 only in
respect of the access port cover.
4.1.11 covers ER 9.1 only in
respect of the suspension hanger
and only if the hanger is not an
integral part of the device.
12.7.1 4.1.2, 4.1.3 Only resistance to mechanical
stress is addressed.
4.1.2 covers ER 12.7.1 only in
respect of temperature and
pressure tolerance.
4.1.3 covers ER 12.7.1 in respect
of resistance to damage by being
dropped.

WARNING 1 — Presumption of conformity stays valid only as long as a reference to the European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of this
standard.
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SIST EN ISO 15747:2019
INTERNATIONAL ISO
STANDARD 15747
Third edition
2018-09
Plastic containers for intravenous
injections
Récipients en plastique pour injections intraveineuses
Reference number
ISO 15747:2018(E)
©
ISO 2018

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SIST EN ISO 15747:2019
ISO 15747:2018(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

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SIST EN ISO 15747:2019
ISO 15747:2018(E)

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 Physical requirements . 2
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 . 3
4.1.9 Access port — Adhesion strength of the infusion device and
impermeability of the insertion point . 3
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 . 4
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
Bibliography .16
© ISO 2018 – All rights reserved iii

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SIST EN ISO 15747:2019
ISO 15747:2018(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 (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 third edition cancels and replaces the second edition (ISO 15747:2010), which has been technically
revised. The main changes compared to the previous edition are as follows:
— the text of the Introduction has been moved as NOTE to the end of the Scope;
— a metallic reference spike has been defined, in Annex D, to harmonise measurement of insertion
point functional properties, for orientation and comparison purpose between different containers;
— the test for tightness of the injection point after piercing with a cannula has been revised to better
define acceptance criteria;
— the wording of the titles of requirements and related tests procedures has been harmonised for
better clarity.
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 © ISO 2018 – All rights reserved

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SIST EN ISO 15747:2019
INTERNATIONAL STANDARD ISO 15747:2018(E)
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.
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 terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //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
3.2
cover
part that protects the access port (3.1) during storage and also provides evidence that the infusion
container has been tampered with
Note 1 to entry: The cover can also envelop the entire container (e.g. outer bag).
© ISO 2018 – All rights reserved 1

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SIST EN ISO 15747:2019
ISO 15747:2018(E)

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 containers (3.11)
4 Requirements
4.1 Physical requirements
For physical tests see Annex A.
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SIST EN ISO 15747:2019
ISO 15747:2018(E)

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 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. Alternative procedures may be used.
Blocking of UV radiation should be considered depending on the content of the container.
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.
Permeability of other gases (e.g. oxygen) should be taken into account depending on the content of the
container.
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.
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
−1
insertion rate of 500 mm·min , 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.
© ISO 2018 – All rights reserved 3

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SIST EN ISO 15747:2019
ISO 15747:2018(E)

Packed 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 cannula
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 procedure 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
For chemical tests see Annex B.
4.2.1 Requirements for the raw container or the sheeting
The sheeting shall fulfil the requirements given in Table 1. Alternatively, it may be tested as described
in the relevant pharmacopoeias.
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
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.
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SIST EN ISO 15747:2019
ISO 15747:2018(E)

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 ≤100
...