EN ISO 1135-4:2011

SLOVENSKI STANDARD
01-januar-2012
1DGRPHãþD
SIST EN ISO 1135-4:2010
Transfuzijska oprema za uporabo v medicini - 4. del: Transfuzijske garniture za
enkratno uporabo (ISO 1135-4:2010)
Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO
1135-4:2010)
Transfusionsgeräte zur medizinischen Verwendung - Teil 4: Transfusionsgeräte zur
einmaligen Verwendung (ISO 1135-4:2010)
Matériel de transfusion à usage médical - Partie 4: Appareils de transfusion non
réutilisables (ISO 1135-4:2010)
Ta slovenski standard je istoveten z: EN ISO 1135-4:2011
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.

EUROPEAN STANDARD
EN ISO 1135-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2011
ICS 11.040.20 Supersedes EN ISO 1135-4:2010
English Version
Transfusion equipment for medical use - Part 4: Transfusion
sets for single use (ISO 1135-4:2010)
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-
4:2010) 4:2010)
This European Standard was approved by CEN on 20 September 2011.

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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 1135-4:2011: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .4

Foreword
This document (EN ISO 1135-4:2011) 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 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 April 2012, and conflicting national standards shall be withdrawn at the
latest by April 2012.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 1135-4:2010.
This new edition contains a revised Annex ZA.
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.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
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, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 1135-4:2010 has been approved by CEN as EN ISO 1135-4:2011 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the 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.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on medical
devices
Clause(s)/subclause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
6, 7.1, 7.3, 7.4, 7.5 7.1 Only chemical toxicity is
addressed (in Clause 6).
Presumption of conformity with
the Essential Requirements
relating to the biological
evaluation can only be provided
if the manufacturer chooses to
apply the EN ISO 10993 series
standards (in Clause 7.1)
Prevention of pyrogenicity
covered (in Clause 7.3)
Prevention of haemolysis
covered (in Clause 7.4)
Prevention of toxicity covered (in
Clause 7.5)
3.2, 5.1, 5.6, 6, 7.1, 7.3, 7.4, 7.5 7.2 The part of ER 7.2 relating to
packaging is not addressed (Æ
for packaging see Clause 9 of
this standard).
Presumption of conformity with
the Essential Requirements
relating to the biological
evaluation can only be provided
if the manufacturer chooses to
apply the EN ISO 10993 series
standards (in Clause 7.1)
Prevention of pyrogenicity
covered (in Clause 7.3)
Prevention of haemolysis
covered (in Clause 7.4)
Prevention of toxicity covered (in
Clause(s)/subclause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
Clause 7.5)
6, 7.1 7.3 Only the first half sentence of ER
7.3 is addressed.
Presumption of conformity with
the Essential Requirements
relating to the biological
evaluation can only be provided
if the manufacturer chooses to
apply the EN ISO 10993 series
standards (in Clause 7.1)
6, 7.1 7.5 Only the first sentence is
covered.
Presumption of conformity with
the Essential Requirements
relating to the biological
evaluation can only be provided
if the manufacturer chooses to
apply the EN ISO 10993 series
standards (in Clause 7.1).
3.2, 5.2, 5.4 7.6
3.2, 5.10, 5.12 8.1 The part of ER 8.1 relating to
handling is not addressed.
Manufacturing processes are not
covered.
The reduction of the risk of
infection is not fully covered.
9 8.3 Only packaging related
protection of sterility is covered.
7.2 8.4 Only the sterilisation method is
covered.
5.3, 5.11 9.1 The second sentence of ER 9.1
is not addressed.
5.7, 5.8, 5.9 10.1 Information relating to the limits
of accuracy is not addressed.
5.3 12.7.1 Only tensile strength is
addressed.
5.5, 5.7, 5.8, 5.9 12.8.1
5.5, 5.7, 5.8, 5.9 12.8.2 Only the first paragraph is
addressed.
8 13.1
8 13.2
Clause(s)/subclause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
3.3, 8 13.3 The part of 13.3a) relating to the
authorized representative is not
addressed. Presumption of
conformity to the rest of 13.3a) is
only provided if the name and
address of the manufacturer are
given.
13.3b) is addressed in Clause
3.3.
13.3d) is only covered if the
batch number is preceded by the
word 'LOT'.
13.3f) relating to single use is
not addressed.
8 13.4 Only addressed regarding the
label.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 1135-4
Fourth edition
2010-04-15
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 1135-4:2010(E)
©
ISO 2010
ISO 1135-4:2010(E)
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ii © ISO 2010 – All rights reserved

ISO 1135-4:2010(E)
Contents Page
Foreword .iv
1 Scope.1
2 Normative references.1
3 General requirements .2
3.1 Nomenclature for components of the transfusion set .2
3.2 Maintenance of sterility.3
3.3 Designation .3
4 Materials .3
5 Physical requirements .3
5.1 Particulate contamination.3
5.2 Leakage .3
5.3 Tensile strength.3
5.4 Closure-piercing device.3
5.5 Tubing.4
5.6 Filter for blood and blood components .4
5.7 Drip chamber and drip tube.4
5.8 Flow regulator.4
5.9 Flow rate of blood and blood components.4
5.10 Injection site.5
5.11 Male conical fitting .5
5.12 Protective caps .5
6 Chemical requirements.5
6.1 Reducing (oxidizable) matter .5
6.2 Metal ions .5
6.3 Titration acidity or alkalinity.5
6.4 Residue on evaporation.5
6.5 UV absorption of extract solution.5
7 Biological requirements.6
7.1 General .6
7.2 Sterility.6
7.3 Pyrogenicity .6
7.4 Haemolysis.6
7.5 Toxicity .6
8 Labelling.6
8.1 Unit container .6
8.2 Shelf or multi-unit container .7
9 Packaging.7
10 Disposal.7
Annex A (normative) Physical tests.8
Annex B (normative) Chemical tests .12
Annex C (normative) Biological tests .14
Bibliography.15

ISO 1135-4:2010(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, and by Technical Committee CEN/TC 205, Non-active medical devices in
collaboration.
This fourth edition cancels and replaces the third edition (ISO 1135-4:2004), which has been revised at
Clause A.1 (Test for particulate contamination). In addition, all requirements regarding the no-longer-used air
inlet device have been deleted. Finally, 5.4 has been revised to improve compatibility between the closure-
piercing device and blood bag ports.
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

iv © ISO 2010 – All rights reserved

INTERNATIONAL STANDARD ISO 1135-4:2010(E)

Transfusion equipment for medical use —
Part 4:
Transfusion sets for single use
1 Scope
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.
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 3826-1:2003, Plastics collapsible containers for human blood and blood components — Part 1:
Conventional containers
ISO 7864:1993, Sterile hypodermic needles for single use
ISO 14644-1:1999, Cleanrooms and associated controlled environments — Part 1: Classification of air
cleanliness
1)
ISO 15223-1:— , Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements

1) To be published. (Revision of ISO 15223-1:2007)
ISO 1135-4:2010(E)
3 General requirements
3.1 Nomenclature for components of the transfusion set
The nomenclature for components of transfusion sets is given in Figure 1.

Key
1 protective cap of the closure-piercing device 7 tubing
2 closure-piercing device 8 flow regulator
3 fluid channel 9 injection site
4 drip tube 10 male conical fitting
5 drip chamber 11 protective cap of the male conical fitting
6 filter for blood and blood components
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 2010 – All rights reserved

ISO 1135-4:2010(E)
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.
3.3 Designation
A transfusion set complying with the requirements of this part of ISO 1135 is designated as follows.
Transfusion set ISO 1135-4
4 Materials
The materials from which the transfusion sets given in Clause 3 are m
...