SIST EN ISO 1135-4:2016

SLOVENSKI STANDARD
01-marec-2016
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SIST EN ISO 1135-4:2012
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Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity
feed (ISO 1135-4:2015)
Transfusionsgeräte zur medizinischen Verwendung - Teil 4: Transfusionsgeräte für
Schwerkrafttransfusionen zur einmaligen Verwendung (ISO 1135-4:2015)
Matériel de transfusion à usage médical - Partie 4: Appareils de transfusion non
réutilisables à alimentation par gravité (ISO 1135-4:2015)
Ta slovenski standard je istoveten z: EN ISO 1135-4:2015
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 2015
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 1135-4:2012
English Version
Transfusion equipment for medical use - Part 4:
Transfusion sets for single use, gravity feed (ISO 1135-
4:2015)
Matériel de transfusion à usage médical - Partie 4: Transfusionsgeräte zur medizinischen Verwendung -
Appareils de transfusion non réutilisables à Teil 4: Transfusionsgeräte für
alimentation par gravité (ISO 1135-4:2015) Schwerkrafttransfusionen zur einmaligen Verwendung
(ISO 1135-4:2015)
This European Standard was approved by CEN on 24 July 2015.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 1135-4:2015 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical devices . 5
European foreword
This document (EN ISO 1135-4:2015) 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 2016, and conflicting national standards shall be
withdrawn at the latest by June 2016.
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.
Together with EN ISO 1135-5:2015 this document supersedes EN ISO 1135-4:2012.
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(s).
For relationship with EU Directive(s), 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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 1135-4:2015 has been approved by CEN as EN ISO 1135-4:2015 without any
modification.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard ‘within the
meaning of Annex ZA’, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated ISO or
IEC standard, as listed in Table 1.
NOTE The way in which these references documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.

Table 1 — Correlations between undated normative references and dated EN and ISO standards
Normative references as listed in Equivalent dated standard
Clause 2 of the ISO standard
EN ISO or IEC
ISO 594-1 --- ISO 594-1:1986
ISO 594-2 --- ISO 594-2:1998
ISO 3696 EN ISO 3696:1995 ISO 3696:1987
ISO 3826-1:2013 EN ISO 3826-1:2013 ISO 3826-1:2013
ISO 3826-2 EN ISO 3826-2:2008 ISO 3826-2:2008
ISO 7864 EN ISO 7864:1995 ISO 7864:1993
ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009
ISO 10993-4 EN ISO 10993-4:2009 ISO 10993-4:2002 plus
ISO 10993-4 AMD 1:2006
ISO 14644-1 EN ISO 14644-1:1999 ISO 14644-1:1999
ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012

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, 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.
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 Directive 93/42/EEC / Directive 90/385/EEC, as amended
by 2007/47/EC. This means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest
possible level’, ‘minimized’ or ‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential
requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on Normative References according to Table of References, replacing the
references in the core text.
NOTE 4 When an Essential 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 Directive 93/42/EEC,
Medical devices
Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) Qualifying remarks/Notes
of Directive 93/42/EEC
3.2 7.2, 8.1
3.3 13.3 b)
4 1, 2, 3
5.1 7.2
5.2 7.6
5.3 9.1, 12.7.1
5.4 7.6
5.5 12.8
5.6 7.2
5.7 12.8
5.8 10, 12.8
5.9 10, 12.8
Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) Qualifying remarks/Notes
of Directive 93/42/EEC
5.10 8
5.11 9.1
5.12 8
6 7
7.1 7, 7.5 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
7.2 8.4
7.3 7.1, 7.2
7.4 7.1, 7.2
7.5 7.1, 7.2
The part of 13.3.a) relating to the
authorized representative is not
8 13 addressed. 13.3.f) and 13.6.h)
relating to single use are not fully
addressed. 13.6.q) is not addressed.
9 5, 8.3
10 13.6 n)
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
Sixth edition
2015-12-01
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
Reference number
ISO 1135-4:2015(E)
©
ISO 2015
ISO 1135-4:2015(E)
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved

ISO 1135-4:2015(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. 2
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
7.6 Assessment of blood component depletion . 6
7.7 Assessment of damage to blood components . 6
8 Labelling . 7
8.1 General . 7
8.2 Unit container . 7
8.3 Shelf or multi-unit container . 7
9 Packaging . 8
10 Disposal . 8
Annex A (normative) Physical tests . 9
Annex B (normative) Chemical tests .13
Annex C (normative) Biological tests .15
Bibliography .16
ISO 1135-4:2015(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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 76, Transfusion, infusion and injection, and blood
processing equipment for medical and pharmaceutical use.
This sixth edition of ISO 1135-4, together with the first edition of ISO 1135-5, cancels and replaces the
fifth edition (ISO 1135-4:2012), which has been technically revised with the following changes:
— the scope has been restricted to gravity feed applications and the whole document aligned accordingly;
— transfusion sets for single use used in conjunction with pressure infusion apparatus are now
covered by ISO 1135-5;
— 3.3 “Designation examples” has been deleted;
— the Normative references and the Bibliography have been updated;
— some minor editorial changes were introduced in the whole document.
ISO 1135 consists of the following parts, under the general title Transfusion equipment for medical use:
— Part 3: Blood-taking sets for single use
— Part 4: Transfusion sets for single use, gravity feed
— Part 5: Transfusion sets for single use with pressure infusion apparatus
iv © ISO 2015 – All rights reserved

INTERNATIONAL STANDARD ISO 1135-4:2015(E)
Transfusion equipment for medical use —
Part 4:
Transfusion sets for single use, gravity feed
1 Scope
This part of ISO 1135 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 part of ISO 1135 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.
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 documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
1)
ISO 594-1 , Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 1: General requirements
1)
ISO 594-2 , Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 2: Lock fittings
ISO 3696, Water for analytical laboratory use — Specification and test methods
ISO 3826-1:2013, 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 14644-1, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness
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 replaced by ISO 80369-7.
ISO 1135-4:2015(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 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
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.
2 © ISO 2015 – All rights reserved

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