SIST EN ISO 1135-4:2016
(Main)Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015)
Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015)
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.
Transfusionsgeräte zur medizinischen Verwendung - Teil 4: Transfusionsgeräte für Schwerkrafttransfusionen zur einmaligen Verwendung (ISO 1135-4:2015)
Dieser Teil von ISO 1135 legt Anforderungen an zur einmaligen Verwendung bestimmte medizinische Transfusionsgeräte für Schwerkrafttransfusionen fest, um sicherzustellen, dass sie zur Verwendung mit Behältern für Blut und Blutbestandteile und Geräten zur intravenösen Punktion geeignet sind.
Weitere Ziele dieses Teils von ISO 1135 sind die Bereitstellung einer Anleitung zu Spezifikationen der Qualität und Leistungsfähigkeit von Werkstoffen, die für Transfusionsgeräte verwendet werden, die Angabe von Benennungen für Einzelteile von Transfusionsgeräten und die Sicherstellung der Kompatibilität der Geräte mit einer Reihe von Zell- und Blutplasmabestandteilen.
In einigen Ländern sind das nationale Arzneibuch oder andere nationale Bestimmungen rechtlich bindend und haben Vorrang vor diesem Teil von ISO 1135.
Matériel de transfusion à usage médical - Partie 4: Appareils de transfusion non réutilisables à alimentation par gravité (ISO 1135-4:2015)
ISO 1135-4:2015 spécifie les exigences relatives aux appareils de transfusion non réutilisables à alimentation par gravité à usage médical, afin d'assurer leur compatibilité avec les conteneurs de sang et de composants sanguins, ainsi qu'avec les dispositifs intraveineux.
Les objectifs secondaires de l'ISO 1135-4:2015 consistent à fournir des préconisations concernant les spécifications de qualité et de performance des matériaux utilisés dans les appareils de transfusion, de proposer des désignations pour les composants de ces appareils de transfusion, et d'assurer la compatibilité de ces appareils avec un large éventail de produits cellulaires et plasmiques du sang.
Dans certains pays, la pharmacopée ou d'autres règlements nationaux sont légalement obligatoires et ont donc préséance sur l'ISO 1135-4:2015.
Transfuzijska oprema za uporabo v medicini - 4. del: Transfuzijske garniture za enkratno uporabo, delujoče na osnovi gravitacije (ISO 1135-4:2015)
Ta del standarda ISO 1135 določa zahteve za transfuzijske garniture za enkratno uporabo, delujoče na osnovi gravitacije, da se zagotovi njihova združljivost z vsebniki za kri in krvne sestavine ter z intravenozno opremo.
Druga cilja tega dela standarda ISO 1135 sta zagotoviti navodila za specifikacije v zvezi s kakovostjo in učinkovitostjo materialov, uporabljenih za transfuzijske garniture, predstaviti oznake za sestavne dele transfuzijskih garnitur, ter zagotoviti združljivost garnitur z naborom celičnih in plazemskih krvnih sestavin.
V nekaterih državah je nacionalna farmakopeja ali druga nacionalna zakonodaja pravno zavezujoča in ima prednost pred tem delom standarda ISO 1135.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 1135-4:2016
01-marec-2016
1DGRPHãþD
SIST EN ISO 1135-4:2012
7UDQVIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQLGHO 7UDQVIX]LMVNHJDUQLWXUH]D
HQNUDWQRXSRUDERGHOXMRþHQDRVQRYLJUDYLWDFLMH ,62
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
SIST EN ISO 1135-4:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 1135-4:2016
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SIST EN ISO 1135-4:2016
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.
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SIST EN ISO 1135-4:2016
EN ISO 1135-4:2015 (E)
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
2
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SIST EN ISO 1135-4:2016
EN ISO 1135-4:2015 (E)
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.
3
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SIST EN ISO 1135-4:2016
EN ISO 1135-4:2015 (E)
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
4
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SIST EN ISO 1135-4:2016
EN ISO 1135-4:2015 (E)
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
5
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SIST EN ISO 1135-4:2016
EN ISO 1135-4:2015 (E)
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.
6
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SIST EN ISO 1135-4:2016
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
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SIST EN ISO 1135-4:2016
ISO 1135-4:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved
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SIST EN ISO 1135-4:2016
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 2015 – All rights reserved iii
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SIST EN ISO 1135-4:2016
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
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SIST EN ISO 1135-4:2016
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 2015 – All rights reserved 1
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SIST EN ISO 1135-4:2016
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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SIST EN ISO 1135-4:2016
ISO 1135-4:2015(E)
4 Materials
The materials from which the transfusion sets 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 limit.
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 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
5.4.2 The closure-piercing device shall be capable of piercing and penetrating the closure of a container
for blood and blood components without prepiercing. 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].
NOTE 2 A central closure-piercing device tip is preferred to an asymmetric design in order to aid its insertion.
5.4.3 When inserted into a blood bag port conforming to ISO 3826-1:2013, the closure-piercing device
shall resist a pull force of 15 N for 15 s.
© ISO 2015 – All rights reserved 3
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SIST EN ISO 1135-4:2016
ISO 1135-4:2015(E)
5.4.4 When tested in accordance with ISO 3826-1:2013, 5.3, the connection between the closure-
piercing device and the blood bag port shall show no evidence of leakage.
5.5 Tubing
5.5.1 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.
5
...
SLOVENSKI STANDARD
oSIST prEN ISO 1135-4:2013
01-december-2013
7UDQVIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQLGHO 7UDQVIX]LMVNHJDUQLWXUH]D
HQNUDWQRXSRUDERGHOXMRþHQDRVQRYLJUDYLWDFLMH ,62',6
Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity
feed (ISO/DIS 1135-4:2013)
Transfusionsgeräte zur medizinischen Verwendung - Teil 4: Transfusionsgeräte für
Schwerkrafttransfusionen zur einmaligen Verwendung (ISO/DIS 1135-4:2013)
Matériel de transfusion à usage médical - Partie 4: Appareils de transfusion non
réutilisables à alimentation par gravité (ISO/DIS 1135-4:2013)
Ta slovenski standard je istoveten z: prEN ISO 1135-4 rev
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
oSIST prEN ISO 1135-4:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 1135-4:2013
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oSIST prEN ISO 1135-4:2013
DRAFT INTERNATIONAL STANDARD
ISO/DIS 1135-4
ISO/TC 76 Secretariat: DIN
Voting begins on: Voting terminates on:
2013-10-03 2014-03-03
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
[Revision of five edition (ISO 1135-4:2012)]
ICS: 11.040.20
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO and
THIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 1135-4:2013(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 2013
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oSIST prEN ISO 1135-4:2013
ISO/DIS 1135-4:2013(E)
Copyright notice
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oSIST prEN ISO 1135-4:2013
ISO/DIS 1135-4
Contents Page
Foreword . v
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
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
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
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Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EC Directive 93/42/EEC on medical devices . 17
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oSIST prEN ISO 1135-4:2013
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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, and blood
processing equipment for medical and pharmaceutical use.
This sixth edition of ISO 1135-4 together with ISO 1135-5, first edition, cancels and replaces the fifth edition
(ISO 1135-4:2012), of which the scope has been restricted to gravity feed 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.
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, gravity feed
Part 5: Transfusion sets for single use with pressure infusion apparatus
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oSIST prEN ISO 1135-4:2013
DRAFT INTERNATIONAL STANDARD ISO/DIS 1135-4
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.
Gravity feed is here defined as unassisted gravity or positive pressure up to 30 kPa. However sets with an
elastomeric buffer (optional) are only rated to 20 kPa.
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 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
1)
equipment — Part 1: General requirements
ISO 594-2:1998, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical
1)
equipment — Part 2: Lock fittings
ISO 3696:1987, 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 7000, Graphical symbols for use on equipment — Index and synopsis
ISO 7864, Sterile hypodermic needles for single use
ISO 14644-1:1999, 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) Will be replaced by ISO 80369-7.
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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 12 elastomeric buffer
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 and elastomeric buffer are optional.
c Optional design.
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.
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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 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 limit.
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 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
5.4.2 The closure-piercing device shall be capable of piercing and penetrating the closure of a container for
blood and blood components without prepiercing. 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 may 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 [11] and [12].
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NOTE 2 A central closure-piercing device tip is preferred to an asymmetric design in order to aid its insertion.
5.4.3 When inserted into a blood bag port conforming to ISO 3826-1, the closure-piercing device shall resist
a pull force of 15 N for 15 s.
5.4.4 When tested in accordance with ISO 3826-1:2013, 5.3, the connection between the closure-piercing
device and the blood bag port shall show no evidence of leakage.
5.5 Tubing
5.5.1 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.
5.5.2 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.
5.6 Filter for blood and blood components
The transfusion set shall be provided with a filter for blood and blood components. The filter shall have
2
uniform pores and shall cover a total area of not less than 10 cm . When tested in accordance with A.3, 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.
5.7 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.
5.8 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.
5.9 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
difference of 10 kPa. The transfusion set shall also deliver not less than 500 ml of blood in 2 min under a
pressure of 30 kPa above atmospheric pressure.
The blood shall be collected into a suitable anticoagulant solution and stored for not less than 2 weeks, and be
free of large clots.
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5.10 Injection site
When provided, the self-sealing injection site shall reseal when tested in accordance with A.4, and there shall
be no leakage of more than one falling drop of water.
Sets fitted with an elastomeric buffer shall be designated “not for use at pressures above 20 kPa after
perforating the elastomeric buffer”.
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.
5.11 Male conical fitting
The distal end of the tubing shall terminate in a male conical fitting conforming with ISO 594-1 or ISO 594-2.
Luer lock fittings in accordance with ISO 594-2 should be used.
5.12 Protective caps
The protective caps at the end of the transfusion set shall maintain the sterility of the closure-piercing device,
the male conical fitting and the interior of the transfusion set.
Protective caps should be secure but easily removable.
6 Chemical requirements
6.1 Reducing (oxidizable) matter
When tested in accordance with B.2, the difference of volume of Na S 0 solution [c(Na S 0 ) = 0,005 mol/l]
2 2 3 2 2 3
for the extract solution, S , and of volume of Na S 0 solution for blank solution, S , shall not exceed 2,0 ml.
1 2 2 3 0
6.2 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 exceed
2+
that of the standard matching solution containing β(Pb ) = 1 µg/ml.
6.3 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.
6.4 Residue on evaporation
When tested in accordance with B.5, the total amount of dry residue shall not exceed 5 mg.
6.5 UV absorption of extract solution
When tested in accordance with B.6, the extract solution, S , shall not show absorption greater than 0,1.
1
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7 Biological requirements
7.1 General
The transfusion set shall not release any substances which may adversely affect the patient (see C.2).
7.2 Sterility
The transfusion set in its unit container shall have been subjected to a validated sterilization process
(see Bibliography).
7.3 Pyrogenicity
The transfusion set shall be assessed for freedom from pyrogens using a suitable test and the results shall
indicate that the transfusion set is free from pyrogenicity. Testing for pyrogenicity shall be carried out in
accordance with Annex C.
7.4 Haemolysis
The transfusion set shall be assessed for freedom from haemolytic constituents and the result shall indicate
that the transfusion set is free from haemolytic reactions. Guidance on testing for haemolytic constituents is
given in ISO 10993-4.
7.5 Toxicity
Materials shall be assessed for toxicity by carrying out suitable tests and the results of the tests shall indicate
freedom from toxicity. Guidance on testing for toxicity is given in ISO 10993-1.
7.6 Assessment of blood component depletion
Sets shall be assessed against the range of blood components for which they are recommended to ensure
that no more than 5 % of the relevant constituent(s) of a single adult therapeutic dose (see Note) of each
blood component is retained by the set. The assessment should compare samples of the blood component
taken prior to and after passage through the transfusion set.
NOTE For guidance, relevant constituents are typically present in the following doses or concentrations:
Red cell components: > 36 g haemoglobin per unit
11
Platelet concentrate: > 2,4 x 10E platelets per unit
Fresh frozen plasma: > 0,7 I.U. Factor VIIIc per ml
7.7 Assessment of damage to blood components
Transfusion sets shall be assessed against the range of blood components for which they are recommended
to ensure that the relevant constituent(s) of each blood component is not significantly damaged (or where
applicable, activated or inactivated) by passage through the set (see Note). The assessment should compare
using a validated test method, samples of the blood component taken prior to and after passage through the
transfusion set.
The clinical relevance of test results should be determined by a competent accredited laboratory.
NOTE For guidance on suitable tests:
+
Red cell components: Haemolysis – supernatant (free) haemoglobin and potassium (K ).
Platelet concentrate: Platelet damage – pH, swirling, hypotonic shock response (HSR), morphology index under
phase microscopy, supernatant lactate dehydrogenase, P-selectin expression (CD62P) on platelet surface and
supernatant, Beta thromboglobulin release.
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Fresh frozen plasma: Coagulation activation – prothrombin fragment 1,2, fibrinopeptide A, Factor XIIa, thrombin-
antithrombin (TAT) complexes.
8 Labelling
8.1 General
The labelling shall include the requirements as specified in 8.2 and 8.3. If graphical symbols are used, then
refer to ISO 3826-2 and ISO 15223-1.
8.2 Unit container
The unit container shall be labelled with the following minimum information using the graphical symbols in
accordance with ISO 15223-1, where appropriate:
a) the name or trade name and address of the manufacturer and, for devices imported into the Community,
in addition the name and address of the authorised representative;
b) description of the contents;
c) indication that the transfusion set is sterile;
d) the lot (batch) designation;
e) year and month of expiry;
f) indication that the transfusion set is for single use only, or equivalent wording;
g) instructions for use, including warnings, e.g. about detached protective caps;
h) indication that the transfusion set is free from pyrogens, or that the transfusion set is free from bacterial
endotoxins;
i) a statement that 20 drops of distilled water delivered by the drip tube are equivalent to (1 ± 0,1) ml
[(1 ± 0,1) g];
j) the nominal dimensions of an intravenous needle, if included;
k) the conditions of both positive and negative pressure under which the set is intended for use;
l) the blood component(s) for which the set is recommended.
NOTE 2 The presence of substances of interest can be indicated by using symbol 2725 of ISO 7000 by replacing
the “XXX” by the abbreviation of the substance. The absence of substances of interest can be indicated by crossing
the respective symbol.
8.3 Shelf or multi-unit container
The shelf or multi-unit container, when used, shall be labelled with the following minimum information using
the graphical symbols in accordance with ISO 15223-1, where appropriate:
a) the name or trade name and address of the manufacturer and, for devices imported into the Community,
in addition the name and address of the authorised representative;
b) description of the contents;
c) indication that the transfusion sets are sterile;
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oSIST prEN IS
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