EN ISO 1135-5:2015

Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015)

ISO 1135-5:2015 specifies requirements for single use transfusion sets for use with pressure infusion equipment capable of generating pressures up to 200 kPa (2 bar). This International Standard ensures compatibility with containers for blood and blood components as well as intravenous equipment.
Secondary aims of ISO 1135-5:2015 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 red cell and plasma blood components.
Platelet components should not be transfused under pressure using these sets.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-5:2015.

Transfusionsgeräte zur medizinischen Verwendung - Teil 5: Transfusionsgeräte zur einmaligen Verwendung mit Druckinfusionsapparaten (ISO 1135-5:2015)

Dieser Teil von ISO 1135 legt Anforderungen an zur einmaligen Verwendung bestimmte Transfusionsgeräte fest, die mit Druckinfusionsapparaten mit erzeugten Drücken bis zu 200 kPa (2 bar) arbeiten. Diese Internationale Norm stellt die Kompatibilität mit Behältern für Blut und Blutbestandteile und Geräten zur intravenösen Punktion sicher.
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 roten Blutkörperchen und Blutplasmabestandteilen.
Thrombozyten-Bestandteile sollten mit diesen Geräten nicht unter Druck übertragen werden.
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 5: Appareils de transfusion non réutilisables avec les appareils de perfusion sous pression (ISO 1135-5:2015)

ISO 1135-5:2015 spécifie les exigences relatives aux appareils de transfusion non réutilisables, couplés à des appareils de perfusion sous pression capables de générer des pressions pouvant atteindre 200 kPa (2 bar). La présente Norme internationale assure la compatibilité avec les conteneurs de sang ou de composants sanguins, ainsi qu'avec le matériel d'injection intraveineuse.
Les objectifs secondaires de l'ISO 1135-5:2015 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 les produits hématiques et plasmiques du sang.
Il convient de ne pas transfuser de plaquettes sous pression avec ces appareils.
Dans certains pays, la pharmacopée ou d'autres règlements nationaux sont légalement obligatoires et ont donc préséance sur l'ISO 1135-5:2015.

Transfuzijska oprema za uporabo v medicini - 5. del: Transfuzijske garniture za enkratno uporabo s tlačno črpalko (ISO 1135-5:2015)

Ta del standarda ISO 1135 opredeljuje zahteve za transfuzijske garniture za enkratno uporabo s tlačno črpalko, ki lahko ustvari tlak do 200 kPa (2 bara). Ta mednarodni standard zagotavlja 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 sestavin celic rdeče vrste in plazemskih krvnih sestavin. V teh garniturah naj ne bi izvajali transfuzije sestavin trombocitov pod tlakom. V nekaterih državah je nacionalna farmakopeja ali druga nacionalna zakonodaja pravno zavezujoča in ima prednost pred tem delom standarda ISO 1135.

General Information

• Status: Published
• Publication Date: 22-Dec-2015
• Withdrawal Date: 29-Jun-2016
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 23-Dec-2015
• Completion Date: 23-Dec-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 1135-5:2016 - Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015)

Relations

• Replaces: EN ISO 1135-4:2012 - Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2012)
• Effective Date: 08-Jun-2022
• Revised: prEN ISO 1135-5 - Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO/DIS 1135-5:2023)
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2016
1DGRPHãþD
SIST EN ISO 1135-4:2012
7UDQVIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQLGHO7UDQVIX]LMVNHJDUQLWXUH]D
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Transfusion equipment for medical use - Part 5: Transfusion sets for single use with
pressure infusion apparatus (ISO 1135-5:2015)
Transfusionsgeräte zur medizinischen Verwendung - Teil 5: Transfusionsgeräte zur
einmaligen Verwendung mit Druckinfusionsapparaten (ISO 1135-5:2015)
Matériel de transfusion à usage médical - Partie 5: Appareils de transfusion non
réutilisables avec des appareils de perfusion sous pression (ISO 1135-5:2015)
Ta slovenski standard je istoveten z: EN ISO 1135-5:2015
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 1135-5
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 5:
Transfusion sets for single use with pressure infusion
apparatus (ISO 1135-5:2015)
Matériel de transfusion à usage médical - Partie 5: Transfusionsgeräte zur medizinischen Verwendung -
Appareils de transfusion non réutilisables avec les Teil 5: Transfusionsgeräte zur einmaligen Verwendung
appareils de perfusion sous pression (ISO 1135- mit Druckinfusionsapparaten (ISO 1135-5:2015)
5:2015)
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 1135-5:2015 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 1135-5:2015) 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 1135-4:2015 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 1135-5:2015 has been approved by CEN as EN ISO 1135-5:2015 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 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
4.2, 6.1, 6.2, 6.3, Clause 7, Clause 8 7.2 The part of ER 7.2 relating to
packaging is not addressed (→ for
packaging see Clause 10 of this
standard).
Clause 5, 6.1, 6.2, 6.3, Clause 7, 7.3 ER covered by biological evaluation
Clause 8
6.2, 6.3, 6.10, 9.2, 9.3, A.2, A.4 7.5 Only the first paragraph is covered.
6.1, 6.3 7.6
4.2, Clause 6 8.1
6.12, Clause 9, Clause 10 8.3 Maintenance of sterility in storage is
covered.
8.2 8.4 Sterilization process is covered.
6.1, A.1 8.5
9.2, 9.3 8.7
Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) Qualifying remarks/Notes
of Directive 93/42/EEC
6.4 9.1 The second sentence of ER 9.1 is not
addressed.
6.4 refers to ISO 3826-1.
Clauses 4, 5, 6, 7, 8 9.2
6.2, 6.3, A.2 12.7 Only 12.7.1 is addressed.
Only tensile strength is addressed.
Clause 9 13.1
9.2, 9.3 13.2 ISO 15223-1 and ISO 3826-2 are
addressed when using symbols.
9.2 a), b), c), d), e), f), g), i), j), k), 9.3 13.3 The part of 13.3a) relating to the
a), b), c), d), e), f), g) 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 3.1 and
4.3.
13.3d) is only covered if the batch
number is preceded by the word
'LOT'.
13.3f) Requirement „indication of
single use must be consistent across
the Community“ is not addressed in
the standard.
13.3g) and h) are not addressed in
the standard.
9.2, 9.3 13.4 13.4 is addressed regarding to 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 1135-5
First edition
2015-12-01
Transfusion equipment for medical
use —
Part 5:
Transfusion sets for single use with
pressure infusion apparatus
Matériel de transfusion à usage médical —
Partie 5: Appareils de transfusion non réutilisables avec les appareils
de perfusion sous pression
Reference number
ISO 1135-5:2015(E)
©
ISO 2015
ISO 1135-5:2015(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
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ii © ISO 2015 – All rights reserved

ISO 1135-5:2015(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 2
4.1 Nomenclature for components of the transfusion set . 2
4.2 Maintenance of sterility. 3
5 Materials . 3
6 Physical requirements . 4
6.1 Particulate contamination . 4
6.2 Leakage . 4
6.3 Tensile strength . 4
6.4 Closure-piercing device .
...