EN ISO 1135-4:2025

SLOVENSKI STANDARD
01-februar-2026
Nadomešča:
SIST EN ISO 1135-4:2016
Transfuzijska oprema za uporabo v medicini - 4. del: Transfuzijske garniture za
enkratno uporabo, delujoče na osnovi gravitacije (ISO 1135-4:2025)
Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity
feed (ISO 1135-4:2025)
Transfusionsgeräte zur medizinischen Verwendung - Teil 4: Transfusionsgeräte für
Schwerkrafttransfusionen zur einmaligen Verwendung (ISO 1135-4:2025)
Matériel de transfusion à usage médical - Partie 4: Transfuseurs non réutilisables, à
alimentation par gravité (ISO 1135-4:2025)
Ta slovenski standard je istoveten z: EN ISO 1135-4:2025
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 1135-4
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2025
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 1135-4:2015
English Version
Transfusion equipment for medical use - Part 4:
Transfusion sets for single use, gravity feed (ISO 1135-
4:2025)
Matériel de transfusion à usage médical - Partie 4: Transfusionsgeräte zur medizinischen Verwendung -
Transfuseurs non réutilisables, à alimentation par Teil 4: Transfusionsgeräte für
gravité (ISO 1135-4:2025) Schwerkrafttransfusionen zur einmaligen Verwendung
(ISO 1135-4:2025)
This European Standard was approved by CEN on 18 May 2025.

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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 1135-4:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 4
European foreword
This document (EN ISO 1135-4:2025) 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 June 2026, and conflicting national standards shall be
withdrawn at the latest by June 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 1135-4:2015.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
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 1135-4:2025 has been approved by CEN as EN ISO 1135-4:2025 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/745 of 5
April 2017 concerning medical devices [OJ L 117] and to system or process requirements including
those relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 and application of the
edition of the normatively referenced standards as given in Table ZA.2 confers, within the limits of the
scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA Regulations.
Where a definition in this harmonised standard differs from a definition of the same term set out in
Regulation (EU) 2017/745, the differences shall be indicated in the Annex Z. For the purpose of using
this standard in support of the requirements set out in Regulation (EU) 2017/745, the definitions set
out in this Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this document
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region the standard can only
support European regulatory requirements to the extent of the scope of the European Regulation for
medical devices ((EU) 2017/745).
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 Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’, ‘removed
or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as possible’, or
‘minimized’, according to the wording of the corresponding General Safety and Performance Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety and
Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 When a General Safety and Performance 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 Regulation (EU)
2017/745 [OJ L 117] and to system or process requirements including those relating to quality
management systems, risk management, post-market surveillance systems, clinical investigations,
clinical evaluation or post-market clinical follow-up
General Safety and
Performance Clause(s) / sub-clause(s)
Remarks / Notes
Requirements of of this EN
Regulation (EU) 2017/745
01 4, 5, 6, 7, 8 Requirement is partially covered
by giving the state of the art of
safe and effective performance
and design.
Normal conditions of use are
determined by providing
pressure and tensile strength
requirements that reflect the
related physical impact to the
devices and by description of the
interfaces to products to be used
with or common performance
parameters like the flow rate,
drip formation and flow
regulation. Safety requirements
are covered with respect to
biological and chemical safety as
well as for particulate
contamination. These
requirements also address the
manufacturing of those devices.
Full assessment of risks
associated with particulate
contamination is not covered by
the standard.
04(a) 4, 5, 6, 7, 8 Requirement is partially covered
by giving the state of the art of
safe design as elaborated for
GSPR 01.
Designs or features that go
beyond the generic design
described in clause 4 might
require additional control
measures. The same applies to
the used manufacturing methods.
04(b) 4.2, 6.13 Requirement is partially covered
for generic designs in relation to
risks that cannot be eliminated by
the provision of protective caps
to prevent contamination from
surrounding environment, to
avoid stick injuries and packaging
damages (subclauses 4.2 and
6.13) as well as by addressing a
test method for the
determination of the level of
particulate contamination.
Full assessment of risks
associated with particulate
contamination is not covered by
the standard.
04(c) 9.2 g), 9.3 e) Requirement of providing, where
appropriate, training to users is
not covered.
05(a) 6.5, 6.7, 6.12, 6.13 Requirement is partially covered
by defining parameters that users
rely on when using the devices,
such as filter performance,
connector compatibility and
prevention of misconnection and
protection from contamination by
requiring protective caps.
Additional specific design and /or
ergonomic features might have to
be validated by the manufacturer
with appropriate measures that
are not addressed by the
standard.
06 5, 6, 7, 8 Requirement is partially covered
by providing the related
performance criteria for the
devices and addressing the
disposal of the device.
However, the standard does not
directly require or address
methods of verifying the entire
product lifetime (e.g. Shelf Life
Studies).
10.1(b) 5, 7, 8 Requirement is fully covered by
providing biocompatibility and
chemical requirements.
10.1(d) 5, 6.2, 7, 8, 10.2 Requirement is partially covered
by performing biological and
chemical testing on finished
medical devices that cover the
influence of manufacturing
processes. Further the influence
of packaging processes is
addressed by 10.2. The formation
of particles during the
manufacturing processes is
addressed by clause 6.2.
Full assessment of risks
associated with particulate
contamination is not covered by
the standard.
10.1(f) 6.3, 6.4, 6.5.2, 6.5.3, 6.5.4, Requirement is fully covered by
6.9, 6.11, 6.12, 6.13 testing for tensile strength and
resistance against leakage,
properties of closure piercing
devices, interactions between
tubing material and flow
regulators, resealing of injection
sites and material properties
specified for conical fittings.
10.1(h) 5, 6, 7 Requirement is fully covered by
providing requirements on used
materials in clause 5, physical
requirements in clause 6 and
chemical requirements in clause
7.
10.2 4.2, 6.2, 6.3, 6.5.4, 6.7, 6.11, Requirement is partially covered
6.12, 6.13, 7, 8, 11 with respect to chemical and
biological requirements, and
testing for leakage, properties of
closure-piercing devices, filter
and residues in form of
particulate contamination.
Full assessment of risks
associated with particulate
contamination is not covered by
the standard.
Requirements related to
minimising the risk to persons
involved in transport of the
devices are not covered.
The document does not specify a
specific assessment method for
bacterial endotoxins and their
related pyrogenicity.
10.5 4.2, 6.3, 6.5.2, 6.5.4, 6.11, Requirement is partially covered
6.13 with respect to the contamination
prevention by requiring caps on
the closure piercing device and
resealing properties of injection
sites.
10.6 4.2, 6.2, 6.5.2, 6.7, 6.13 Requirement is partially covered
by addressing a test method for
the determination of the level of
particulate contamination. Full
assessment of risks associated
with particulate contamination is
not covered by the standard.
Requirement related to special
attention regarding
nanomaterials is not covered.
11.1 (a) 6.13 Requirement is covered as
applicable for a generic design by
requiring protective caps
according to clause 6.13.
11.1 (c) 6.3, 6.5.4, 6.11 Requirement is covered with
respect to leakage requirements,
physical integrity and (re-)
sealing to prevent exposure of
blood and the included microbes
by leaking from the device.
11.1(d) 4.2, 6.2, 6.3, 6.5.4, 6.11, 6.13, Requirement is covered with
10.1 respect to contamination
prevention by the presence of
protective caps, resealing of
injections sites and sterile
packaging requirements.
14.1 6.5, 6.11, 6.12 Requirements for the following
device combinations are covered:
—  closure-piercing device and
closure of a container for blood
and blood components (sub-
clause 6.5)
—  self-sealing injection site and
hypodermic needle / needle-free
injection ports or Luer-activated
devices and male Luer cone (sub-
clause 6.11)
—  male and female conical
fitting (sub-clause 6.12)
14.2 (a) 4.2, 6.5.2, 6.13 Requirement partially covered by
requiring needle stick prevention
with protective caps.
14.2(e) 4.2, 6.3, 6.4, 6.5.3, 6.5.4, 6.11, Requirement related to reduce
6.12, 6.13 the risks of accidental ingress of
substances into the devices is
covered by:
—  protective caps (sub-
clauses 4.2, 6.13)
—  prevention of leakage (sub-
clauses 6.3, 6.5.4, 6.11)
—  tensile strength of
connections (sub-clauses 6.4,
6.5.3)
—  standardized connection of
male conical fitting (sub-
clause 6.12)
14.5 6.5.3, 6.5.4, 6.11, 6.12 Requirement related to
interoperability and
compatibility with other devices
or products are covered as
follows:
—  compatibility of closure-
piercing device and blood bag
port (sub-clauses 6.5.3, 6.5.4)
—  compatibility of self-sealing
injection site and hypodermic
needle as well as needle-free
injection ports or Luer-activated
devices and male Luer cone (sub-
clause 6.11)
—  compatibility of male and
female conical fittings (sub-
clause 6.12)
23.1 (b) 9 Requirement is fully covered by
specifying labelling requirements
for packaging, as labelling on the
device itself does not seem
reasonable for these devices.
23.2 (b) 9.2 b), c), f), g), h), i), j), k), l), Requirement covered by
specifying the determining design
9.3 b), e), f)
parameters of the devices, such
as the sterility, non-pyrogenicity,
number of drops per 1 ml and the
indication of the gravity
application.
Table ZA.2 — Normative references from clause 2 of this document and their corresponding
European publications
Column 1 Column 2 Column 3 Column 4
Reference in International Title Corresponding European
Clause 2 Standard Edition Standard Edition
ISO 3696 ISO 3696:1987 Water for analytical EN ISO 3696:1995
laboratory use —
Specification and test
methods
ISO 3826- ISO 3826-1:2019 Plastics collapsible EN ISO 3826-1:2019
1:2019 containers for human blood
ISO 3826- EN ISO 3826-1:2019/A1:2023
and blood components —
1:2019/Amd
Part 1: Conventional
1:2023
containers
ISO 7864 ISO 7864:2016 Sterile hypodermic needles EN ISO 7864:2016
for single use -
Requirements and test
methods
ISO 10993-1 ISO 10993-1:2018 Biological evaluation of EN ISO 10993-1:2020
medical devices - Part 1:
Evaluation and testing
within a risk management
process
ISO 10993- ISO 10993-4:2017 Biological evaluation of EN ISO 10993-4:2017
4:2017 medical devices - Part 4:
Selection of tests for
interactions with blood
ISO 10993-12 ISO 10993-12:2021 Biological evaluation of EN ISO 10993-12:2021
medical devices - Part 12:
Sample preparation and
reference materials
ISO 11607-1 ISO 11607-1:2019 Packaging for terminally EN ISO 11607-1:2020
sterilized medical devices -
ISO 11607- EN ISO 11607-
Part 1: Requirements for
12019/Amd 1:2023 1:2020/A11:2022
materials, sterile barrier
EN ISO 11607-1:2020/A1:2023
systems and packaging
systems
ISO 14644-1 ISO 14644-1:2015 Cleanrooms and associated EN ISO 14644-1:2015
controlled environments -
Part 1: Classification of air
cleanliness by particle
concentration
ISO 15223-1 ISO 15223-1:2021 Medical devices - Symbols EN ISO 15223-1:2021
to be used with information
to be supplied by the
manufacturer - Part 1:
General requirements
Column 1 Column 2 Column 3 Column 4
Reference in International Title Corresponding European
Clause 2 Standard Edition Standard Edition
ISO 80369-7 ISO 80369-7:2021 Small-bore connectors for EN ISO 80369-7:2021
liquids and gases in
healthcare applications -
Part 7: Connectors for
intravascular or
hypodermic applications
ISO 80369-20 ISO 80369-20:2024 Small-bore connectors for EN ISO 80369-20:2024
liquids and gases in
healthcare applications -
Part 20: Common test
methods
The documents listed in the Column 1 of Table ZA.2, in whole or in part, are normatively referenced in
this document, i.e. are indispensable for its application. The achievement of the presumption of
conformity is subject to the application of the edition of Standards as listed in Column 4 or, if no
European Standard Edition exists, the International Standard Edition given in Column 2 of Table ZA.2.
WARNING 1 Presumption of conformity stays valid only as long as a reference to this 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 product(s) falling within the scope of
this standard.
International
Standard
ISO 1135-4
Seventh edition
Transfusion equipment for
2025-05
medical use —
Part 4:
Transfusion sets for single use,
gravity feed
Matériel de transfusion à usage médical —
Partie 4: Transfuseurs non réutilisables, à alimentation par
gravité
Reference number
ISO 1135-4:2025(en) © ISO 2025

ISO 1135-4:2025(en)
© ISO 2025
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 1135-4:2025(en)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 2
5 Materials . 3
6 Physical requirements . 3
6.1 General .3
6.2 Particulate contamination .3
6.3 Leakage .3
6.4 Tensile strength .3
6.5 Closure-piercing device .3
6.6 Tubing .4
6.7 Filter for blood and blood components .4
6.8 Drip chamber and drip tube .4
6.9 Flow regulator .4
6.10 Flow rate of blood and blood components .4
6.11 Injection site .5
6.12 Male conical fitting .5
6.13 Protective caps .5
7 Chemical requirements . 5
7.1 Reducing (oxidizable) matter .5
7.2 Metal ions .5
7.3 Titration acidity or alkalinity.5
7.4 Residue on evaporation .5
7.5 UV absorption of extract solution .6
8 Biological requirements . 6
8.1 General .6
8.2 Sterility .6
8.3 Additional device specific requirements .6
9 Labelling . 6
9.1 General .6
9.2 Unit container .7
9.3 Shelf or multi-unit container .7
10 Packaging. 8
11 Disposal . 8
Annex A (normative) Physical tests . . 9
Annex B (normative) Chemical tests .13
Bibliography .15

iii
ISO 1135-4:2025(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 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 seventh edition cancels and replaces the sixth edition (ISO 1135-4:2015), which has been technically
revised.
The main changes are as follows:
— 6.11 “Inj
...