ISO 1135-4:2004

Transfusion equipment for medical use — Part 4: Transfusion sets for single use

ISO 1135-4:2004 specifies requirements for single-use transfusion sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment. ISO 1135-4:2004 also specifies requirements for air-inlet devices for use with rigid containers for blood and blood components. Secondary aims of ISO 1135-4:2004 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets and to present designations for transfusion set components. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-4:2004.

Matériel de transfusion à usage médical — Partie 4: Appareils de transfusion non réutilisables

General Information

• Status: Withdrawn
• Publication Date: 12-Jul-2004
• Withdrawal Date: 12-Jul-2004
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
• Drafting Committee: ISO/TC 76/WG 1 - Soft containers for blood, blood components and parenterals; Infusion, transfusion and blood processing equipment
• Current Stage: 9599 - Withdrawal of International Standard
• Completion Date: 15-Apr-2010

Relations

• Revised: ISO 1135-4:2010 - Transfusion equipment for medical use — Part 4: Transfusion sets for single use
• Effective Date: 15-Apr-2008
• Consolidates: ISO/TR 3836:1978 - Shoe sizes — System of width grading (for use in the Mondopoint system)
• Effective Date: 06-Jun-2022
• Revises: ISO 1135-4:1998 - Transfusion equipment for medical use — Part 4: Transfusion sets for single use
• Effective Date: 15-Apr-2008

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 1135-4
Third edition
2004-07-15
Transfusion equipment for medical use —
Part 4:
Transfusion sets for single use
Matériel de transfusion à usage médical —
Partie 4: Appareils de transfusion non réutilisables

Reference number
ISO 1135-4:2004(E)
©
ISO 2004

---------------------- Page: 1 ----------------------
ISO 1135-4:2004(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall
not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the
unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2004
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56  CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland
©
ii ISO 2004 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 1135-4:2004(E)
Contents Page
1 Scope . 1
2 Normative references . 1
3 General requirements . 1
3.1 Nomenclature for components of the transfusion set . 1
3.2 Maintenance of sterility . 3
3.3 Designation . 3
4 Materials . 4
5 Physical requirements . 4
5.1 Particulate contamination . 4
5.2 Leakage . 4
5.3 Tensile strength . 4
5.4 Closure-piercing device . 4
5.5 Air-inlet device . 5
5.6 Tubing . 5
5.7 Filter for blood and blood components . 5
5.8 Drip chamber and drip tube . 5
5.9 Flow regulator . 5
5.10 Flow rate of blood and blood components . 5
5.11 Injection site . 6
5.12 Male conical fitting . 6
5.13 Protective caps . 6
6 Chemical requirements . 6
6.1 Reducing (oxidizable) matter . 6
6.2 Metal ions . 6
6.3 Titration acidity or alkalinity . 6
6.4 Residue on evaporation . 6
6.5 UV absorption of extract solution . 6
7 Biological requirements . 7
7.1 General . 7
7.2 Sterility . 7
7.3 Pyrogenicity . 7
7.4 Haemolysis . 7
7.5 Toxicity . 7
8 Labelling . 7
8.1 Unit container . 7
8.2 Shelf or multi-unit container . 8
9 Packaging . 8
Annex A (normative) Physical tests . 9
Annex B (normative) Chemical tests . 13
©
ISO 2004 – All rights reserved iii

---------------------- Page: 3 ----------------------
ISO 1135-4:2004(E)
Annex C (normative) Biological tests . 15
Bibliography . 16
©
iv ISO 2004 – All rights reserved

---------------------- Page: 4 ----------------------
ISO 1135-4:2004(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 1135-4 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for
medical and pharmaceutical use.
This third edition cancels and replaces the second edition (ISO 1135-4:1998), which has been technically
revised.
ISO 1135 consists of the following parts, under the general title Transfusion equipment for medical use:
— Part 3: Blood-taking set
— Part 4: Transfusion sets for single use
©
ISO 2004 – All rights reserved v

---------------------- Page: 5 ----------------------
.
vi

---------------------- Page: 6 ----------------------
INTERNATIONAL STANDARD ISO 1135-4:2004(E)
Transfusion equipment for medical use —
Part 4:
Transfusion sets for single use
1Scope
This part of ISO 1135 specifies requirements for single-use transfusion sets for medical use in order to ensure
their compatibility with containers for blood and blood components as well as with intravenous equipment.
This part of ISO 1135 also specifies requirements for air-inlet devices for use with rigid containers for blood and
blood components.
Secondary aims of this part of ISO 1135 are to provide guidance on specifications relating to the quality and
performance of materials used in transfusion sets and to present designations for transfusion set components.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take
precedence over this part of ISO 1135.
2 Normative references
The following referenced documents are indispensable for the application 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 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 1: General requirements
ISO 594-2:1998, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 2: Lock fittings
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO 7864:1993, Sterile hypodermic needles for single use
ISO 14644-1:1999, Cleanrooms and associated controlled environments — Part1: Classification of air
cleanliness
ISO 15223, Medical devices — Symbols to be used with medical device labels, labelling and information to be
supplied
3 General requirements
3.1 Nomenclature for components of the transfusion set
The nomenclature for components of transfusion sets is given in Figure 1. An air-inlet device as shown in
Figure 2 is required for use with rigid containers for blood and blood components.
©
ISO 2004 – All rights reserved 1

---------------------- Page: 7 ----------------------
ISO 1135-4:2004(E)
Key
1 protective cap of the closure-piercing device
2 closure-piercing device
3 fluid channel
4 drip tube
5 drip chamber
6 filter for blood and blood components
7tubing
8 flow regulator
9 injection site
10 male conical fitting
11 protective cap of the male conical fitting
a
Indicates alternative locations of the filter for blood and blood components. Other designs are acceptable if the same
safety aspects are ensured.
b
Injection site is optional.
Figure 1 — Example of a transfusion set
©
2 ISO 2004 – All rights reserved

---------------------- Page: 8 ----------------------
ISO 1135-4:2004(E)
Key
1 protective cap
2 closure-piercing device or needle
3tubing
4clamp
5 air-inlet with air filter
a
Other designs are acceptable if the same safety aspects are ensured.
Figure 2 — Example of an air-inlet device
NOTE Figure 1 illustrates an example of a transfusion set. Figure 2 illustrates a separate air-inlet device. Figures 1 and 2
do not form part of the requirements for transfusion sets for single use as specified in this part of ISO 1135.
3.2 Maintenance of sterility
The transfusion set shall be provided with protective caps to maintain sterility of the internal parts of the set until
the set is used. The air-inlet device shall be provided with a protective cap over the closure-piercing device or
needle.
3.3 Designation
3.3.1 Transfusion set
An example of the designation of a transfusion set complying with the requirements of this part of ISO 1135 is
as follows:
Transfusion set ISO 1135-4 TS
3.3.2 Air-inlet device
An example of the designation of an air-inlet device complying with the requirements of this part of ISO 1135 is
as follows:
Air-inlet device ISO 1135-4 AD
©
ISO 2004 – All rights reserved 3

---------------------- Page: 9 ----------------------
ISO 1135-4:2004(E)
4Materials
The materials from which the transfusion set and its air-inlet device as given in Clause 3 are manufactured shall
comply with the requirements specified in Clause 5. If components of the transfusion set come into contact with
blood and blood components, they shall additionally comply with the requirements specified in Clauses 6 and 7.
5 Physical requirements
5.1 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.1, the number of
particles detected shall not exceed the contamination index.
5.2 Leakage
The transfusion set, when tested in accordance with A.2, shall show no signs of air leakage.
5.3 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.
5.4 Closure-piercing device
5.4.1 The dimensions of the closure-piercing device shall conform with the dimensions shown in Figure 3.
NOTE The dimension of 15 mm in Figure 3 is a reference measurement. The cross-section of the piercing device at this
site is a circle.
Dimensions in millimetres
Figure 3 — Dimensions of the closure-piercing device
5.4.2 The closure-piercing device, and the air-inlet device if used, 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.
5.5 Air-inlet device
5.5.1 The air-inlet device shall also conform with 3.3 and 7.2.
©
4 ISO 2004 – All rights reserved

---------------------- Page: 10 ----------------------
ISO 1135-4:2004(E)
5.5.2 The air-inlet device shall be provided with an air filter to prevent the ingress of microorganisms into the
container into which the device is to be inserted.
5.5.3 The air-inlet device shall be separate from the closure-piercing device.
5.5.4 If the end of the air-inlet device is connected to an air filter by means of flexible tubing, the tubing shall be
not less than in length.
250 mm
5.5.5 The air filter shall be fitted in such a manner that all air entering the rigid container passes through it and
that the flow of fluid is not reduced by more than 20 % of that from a freely ventilated container when tested in
accordance with A.3.
5.6 Tubing
5.6.1 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.
5.6.2 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.
5.7 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
2
10 cm
pores and shall cover a total area of not less than . When tested in accordance with Annex A, 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.
5.8 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
◦
5mm 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.
5.9 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.
5.10 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
difference of 10 kPa
...