EN ISO 1135-4:2025

SLOVENSKI STANDARD
oSIST prEN ISO 1135-4:2023
01-december-2023
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/DIS 1135-4:2023)
Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity
feed (ISO/DIS 1135-4:2023)
Transfusionsgeräte zur medizinischen Verwendung - Teil 4: Transfusionsgeräte für
Schwerkrafttransfusionen zur einmaligen Verwendung (ISO/DIS 1135-4:2023)
Matériel de transfusion à usage médical - Partie 4: Transfuseurs non réutilisables, à
alimentation par gravité (ISO/DIS 1135-4:2023)
Ta slovenski standard je istoveten z: prEN ISO 1135-4
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
oSIST prEN ISO 1135-4:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 1135-4:2023
oSIST prEN ISO 1135-4:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 1135-4
ISO/TC 76 Secretariat: DIN
Voting begins on: Voting terminates on:
2023-10-12 2024-01-04
Transfusion equipment for medical use —
Part 4:
Transfusion sets for single use, gravity feed
Matériel de transfusion à usage médical —
Partie 4: Appareils de transfusion non réutilisables à alimentation par gravité
ICS: 11.040.20
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
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NATIONAL REGULATIONS.
ISO/DIS 1135-4:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

oSIST prEN ISO 1135-4:2023
ISO/DIS 1135-4:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 1135-4
ISO/TC 76 Secretariat: DIN
Voting begins on: Voting terminates on:

Transfusion equipment for medical use —
Part 4:
Transfusion sets for single use, gravity feed
Matériel de transfusion à usage médical —
Partie 4: Appareils de transfusion non réutilisables à alimentation par gravité
ICS: 11.040.20
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
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NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 1135-4:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
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NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

oSIST prEN ISO 1135-4:2023
ISO/DIS 1135-4:2023(E)
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 Particulate contamination . 3
6.2 Leakage . 3
6.3 Tensile strength . 3
6.4 Closure-piercing device . 3
6.5 Tubing . 4
6.6 Filter for blood and blood components . 4
6.7 Drip chamber and drip tube . 4
6.8 Flow regulator . 4
6.9 Flow rate of blood and blood components . 4
6.10 Injection site . 5
6.11 Male conical fitting . 5
6.12 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 Pyrogenicity . 6
8.4 Haemolysis . 6
8.5 Toxicity . 6
8.6 Assessment of blood component depletion . 6
8.7 Assessment of damage to blood components. 6
9 Labelling . 7
9.1 General . 7
9.2 Unit container . 7
9.3 Shelf or multi-unit container . 8
10 Packaging. 8
11 Disposal . 8
Annex A (normative) Physical tests . .9
Annex B (normative) Chemical tests .13
Annex C (normative) Biological tests .15
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered .16
Bibliography .20
iii
oSIST prEN ISO 1135-4:2023
ISO/DIS 1135-4:2023(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, 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 of ISO 1135-4 cancels and replaces the sixth edition (ISO 1135-4:2015), which has
been technically revised with the following changes:
— 6.10 “Injection site” has been amended in regard of the use of needle-free injection ports and Luer-
activated devices;
— 6.12 “Protective caps” has been more clarified how to prevent contamination;
— Clause 9 “Labelling” has been updated especially in regard of the referenced ISO 15223-1;
— Clause 10 “Packaging” has been amended by a reference to ISO 11607-1;
— Annex A “Physical test” has been amended by a general introduction on the pre-conditioning. In
addition the description of the test for leakage has been extended;
— the Normative references have been updated;
— some minor editorial changes were introduced in the whole document.
A list of all parts in the ISO 1135 series can be found on the ISO website.
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
oSIST prEN ISO 1135-4:2023
DRAFT INTERNATIONAL STANDARD ISO/DIS 1135-4:2023(E)
Transfusion equipment for medical use —
Part 4:
Transfusion sets for single use, gravity feed
1 Scope
This document specifies requirements for single use transfusion gravity sets for medical use in order to
ensure their compatibility with containers for blood and blood components as well as with intravenous
equipment.
Secondary aims of this document are to provide guidance on specifications relating to the quality
and performance of materials used in transfusion sets, to present designations for transfusion
set components, and to ensure the compatibility of sets with a range of cellular and plasma blood
components.
NOTE In some countries, the national pharmacopoeia or other national regulations are legally binding and
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 3696, Water for analytical laboratory use — Specification and test methods
ISO 3826-1:2019, Plastics collapsible containers for human blood and blood components — Part 1:
Conventional containers
ISO 3826-2, Plastics collapsible containers for human blood and blood components — Part 2: Graphical
symbols for use on labels and instruction leaflets
ISO 7864, Sterile hypodermic needles for single use
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 10993-4, Biological evaluation of medical devices — Part 4: Selection of tests for interactions with
blood
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
ISO 14644-1, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness
ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer
— Part 1: General requirements
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors
for intravascular or hypodermic applications
ISO 80369-20, Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common
test methods
oSIST prEN ISO 1135-4:2023
ISO/DIS 1135-4:2023(E)
3 Terms and definitions
No terms and definitions are listed in this document.
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/
4 General requirements
4.1 The nomenclature for components of transfusion sets is given in Figure 1.
Key
1 protective cap of the closure-piercing device 9 injection site
2 closure-piercing device 10 male conical fitting
3 fluid channel 11 protective cap of the male conical fitting
4 drip tube 12 elastomeric buffer
a
5 drip chamber Indicates alternative locations of the filter for blood
and blood components. Other designs are acceptable,
if the same safety aspects are ensured.
b
6 filter for blood and blood components Injection site and elastomeric buffer are optional.
c
7 tubing Optional design.
8 flow regulator
Figure 1 — Example of a transfusion set
oSIST prEN ISO 1135-4:2023
ISO/DIS 1135-4:2023(E)
4.2 The transfusion set shall be provided with protective caps.
5 Materials
The materials from which the transfusion sets given in Clause 4 are manufactured shall comply with the
requirements specified in Clause 6. If components of the transfusion set come into contact with blood
and blood components, they shall additionally comply with the requirements specified in Clauses 7
and 8.
6 Physical requirements
6.1 Particulate contamination
The transfusion sets shall be manufactured under conditions that minimize particulate contamination.
All parts shall be smooth and clean at the fluid pathway surfaces. When tested as specified in A.2, the
number of particles detected shall not exceed the contamination index limit.
6.2 Leakage
The transfusion set, when tested in accordance with A.3, shall show no signs of air leakage.
6.3 Tensile strength
Any connections between the components of the transfusion set, excluding protective caps, shall
withstand a static tensile force of not less than 15 N for 15 s.
6.4 Closure-piercing device
6.4.1 The dimensions of the closure-piercing device shall conform to the dimensions shown in
Figure 2.
NOTE The dimension of 15 mm in Figure 2 is a reference measurement. The cross-section of the piercing
device at this site is a circle.
Dimensions in millimetres
Figure 2 — Dimensions of the closure-piercing device
6.4.2 The closure-piercing device shall be capable of piercing and penetrating the closure of a
container for blood and blood components without pre-piercing. No coring should occur during this
procedure.
NOTE 1 A carefully controlled surface treatment of the closure-piercing device (e.g. siliconization) is
recommended to facilitate its insertion into the blood bag port. The same effect can be achieved by a careful
selection of material for the closure-piercing device. Typical results including test equipment for penetration
forces between spikes and blood bag ports have been published. See References [9] and [10].
oSIST prEN ISO 1135-4:2023
ISO/DIS 1135-4:2023(E)
NOTE 2 A central closure-piercing device tip is preferred to an asymmetric design in order to aid its insertion.
6.4.3 When inserted into a blood bag port conforming to ISO 3826-1:2019, the closure-piercing device
shall resist a pull force of 15 N for 15 s.
6.4.4 When tested in accordance with ISO 3826-1:2019, 5.3, the connection between the closure-
piercing device and the blood bag port shall show no evidence of leakage.
6.5 Tubing
6.5.1 The tubing, made of flexible material, shall be transparent or sufficiently translucent so that the
interface of air and water during the passage of air bubbles can be observed with normal or corrected-
to-normal vision.
6.5.2 The tubing from the distal end to the drip chamber shall be not less than 1 500 mm in length,
including the injection site, when provided, and the male conical fitting.
6.6 Filter for blood and blood components
The transfusion set shall be provided with a filter for blood and blood components. The filter shall have
uniform pores and shall cover a total area of not less than 10 cm . When tested in accordance with
1)
A.4 , the mass of solid material retained on the filter shall be not less than 80 % (mass fraction) of that
retained on the reference filter.
If the filter has a confirmed thread diameter of (100 ± 10) µm and a pore size of (200 ± 20) µm, with a
single warp and a single weft, a filtration performance test can be exempted.
Pore size measurement can be performed by microscopic inspection.
6.7 Drip chamber and drip tube
The drip chamber shall permit continuous observation of the fall of drops. The liquid shall enter the
drip chamber through a tube which projects into the chamber. There shall be a distance of not less
than 40 mm between the end of the drip tube and the outlet of the chamber, or a distance of not less
than 20 mm between the drip tube and the filter for blood and blood components. The wall of the drip
chamber shall not be closer than 5 mm to the end of the drip tube. The drip tube shall be such that
20 drops of distilled water at (23 ± 2) °C and at a flow rate of (50 ± 10) drops/min deliver (1 ± 0,1) ml
[(1 ± 0,1) g].
The drip chamber should permit and facilitate the procedure of priming.
6.8 Flow regulator
The flow regulator shall adjust the flow of the blood and blood components between zero and maximum.
The flow regulator should be capable of continuous use throughout a transfusion without the tubing
being damaged. There should be no deleterious reaction between the flow regulator and the tubing
when stored in such a manner that there is contact.
6.9 Flow rate of blood and blood components
The transfusion set shall deliver not less than 1 000 ml of blood at (23 ± 2) °C in 30 min with a pressure
2)
difference of 10 kPa . The transfusion set shall also deliver not less than 500 ml of blood in 2 min under
a gauge pressure of 30 kPa above atmospheric pressure.

1) In countries where human blood is not available for testing, equivalent test methods may be established.
oSIST prEN ISO 1135-4:2023
ISO/DIS 1135-4:2023(E)
The blood shall be collected into a suitable anticoagulant solution and stored for not less than 2 weeks,
and be free of large clots.
6.10 Injection site
When provided, the self-sealing injection site shall reseal when tested in accordance with A.5, and there
shall be no leakage of water.
Sets fitted with an elastomeric buffer shall be designated “not for use at pressures above 20 kPa after
perforating the elastomeric buffer”.
Needle-free injection ports or Luer-activated devices shall be used in accordance with the instructions
for use and tested to a minimum gauge pressure of 20 kPa unless otherwise required. There shall be no
leakage of water when tested in accordance to A.5 with the exception of using a male Luer cone instead
of a needle.
The injection site should be located near the male conical fitting.
NOTE The co-administration of drugs through the injection site is not permitted in some countries.
6.11 Male conical fitting
The distal end of the tubing shall terminate in a male conical fitting conforming with ISO 80369-7 and
ISO 80369-20.
6.12 Protective caps
The protective caps shall cover the respective surfaces of the infusion equipment to prevent
contamination from surrounding environment to avoid stick injuries and packaging damages.
Protective caps should be secure but easily removable.
7 Chemical requirements
7.1 Reducing (oxidizable) matter
When tested in accordance with B.2, the difference of volume of Na S 0 solution
2 2 3
[c(Na S 0 ) = 0,005 mol/l] for the extract solution, S , and of volume of Na S 0 solution for blank
2 2 3 1 2 2 3
solution, S , shall not exceed 2,0 ml.
7.2 Metal ions
The extract shall not contain in total more than 1 µg/ml of barium, chromium, copper, lead, and tin, and
not more than 0,1 µg/ml of cadmium, when determined by atomic absorption spectroscopy (AAS) or an
equivalent method.
When tested in accordance with B.3, the intensity of the colour produced in the test solution shall not
2+
exceed that of the standard matching solution containing (Pb ) = 1 µg/ml.
7.3 Titration acidity or alkalinity
When tested in accordance with B.4, not more than 1 ml of either standard volumetric solution shall be
required for the indicator to change to the colour grey.
7.4 Residue on evaporation
When tested in accordance with B.5, the total amount of dry residue shall not exceed 5 mg.
oSIST prEN ISO 1135-4:2023
ISO/DIS 1135-4:2023(E)
7.5 UV absorption of extract solution
When tested in accordance with B.6, the extract solution, S , shall not show absorption greater than 0,1.
8 Biological requirements
8.1 General
The transfusion set shall not release any substances which may adversely affect the patient, see C.2.
8.2 Sterility
The transfusion set in its unit container shall have been subjected to a validated sterilization process
(see References [2], [3], and [4]).
8.3 Pyrogenicity
The transfusion set shal
...