SIST EN ISO 1135-4:2005

SLOVENSKI STANDARD
SIST EN ISO 1135-4:2005
01-januar-2005
Transfuzijska oprema za uporabo v medicini – 4. del: Transfuzijske garniture za
enkratno uporabo (ISO 1135-4:2004)
Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO
1135-4:2004)
Transfusionsgeräte zur medizinischen Verwendung - Teil 4: Transfusionsgeräte zur
einmaligen Verwendung (ISO 1135-4:2004)
Matériel de transfusion a usage médical - Partie 4: Appareils de transfusion non
réutilisables (ISO 1135-4:2004)
Ta slovenski standard je istoveten z: EN ISO 1135-4:2004
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 1135-4:2005 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 1135-4:2005

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SIST EN ISO 1135-4:2005
EUROPEAN STANDARD
EN ISO 1135-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2004
ICS 11.040.20
English version
Transfusion equipment for medical use - Part 4: Transfusion
sets for single use (ISO 1135-4:2004)
Matériel de transfusion à usage médical - Partie 4: Transfusionsgeräte zur medizinischen Verwendung - Teil 4:
Appareils de transfusion non réutilisables (ISO 1135- Transfusionsgeräte zur einmaligen Verwendung (ISO 1135-
4:2004) 4:2004)
This European Standard was approved by CEN on 22 June 2004.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 1135-4:2004: E
worldwide for CEN national Members.

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SIST EN ISO 1135-4:2005

EN ISO 1135-4:2004 (E)





Foreword


This document (EN ISO 1135-4:2004) has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection 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 BSI.

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 January 2005, and conflicting national
standards shall be withdrawn at the latest by January 2005.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.


Endorsement notice

The text of ISO 1135-4:2004 has been approved by CEN as EN ISO 1135-4:2004 without any
modifications.

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SIST EN ISO 1135-4:2005
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

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SIST EN ISO 1135-4:2005
ISO 1135-4:2004(E)
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©
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SIST EN ISO 1135-4:2005
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
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SIST EN ISO 1135-4:2005
ISO 1135-4:2004(E)
Annex C (normative) Biological tests . 15
Bibliography . 16
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SIST EN ISO 1135-4:2005
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
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SIST EN ISO 1135-4:2005
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SIST EN ISO 1135-4:2005
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.
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SIST EN ISO 1135-4:2005
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
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SIST EN ISO 1135-4:2005
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
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SIST EN ISO 1135-4:2005
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.
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SIST EN ISO 1135-4:2005
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
...