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
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
23-Dec-2015
Completion Date
23-Dec-2015

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SLOVENSKI STANDARD
SIST EN ISO 1135-5:2016
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
SIST EN ISO 1135-5:2016 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 1135-5:2016
---------------------- Page: 2 ----------------------
SIST EN ISO 1135-5:2016
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 1135-5:2016
EN ISO 1135-5:2015 (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

---------------------- Page: 4 ----------------------
SIST EN ISO 1135-5:2016
EN ISO 1135-5:2015 (E)
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.
---------------------- Page: 5 ----------------------
SIST EN ISO 1135-5:2016
EN ISO 1135-5:2015 (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 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
---------------------- Page: 6 ----------------------
SIST EN ISO 1135-5:2016
EN ISO 1135-5:2015 (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
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
---------------------- Page: 7 ----------------------
SIST EN ISO 1135-5:2016
EN ISO 1135-5:2015 (E)

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.
---------------------- Page: 8 ----------------------
SIST EN ISO 1135-5:2016
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
---------------------- Page: 9 ----------------------
SIST EN ISO 1135-5:2016
ISO 1135-5:2015(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
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
---------------------- Page: 10 ----------------------
SIST EN ISO 1135-5:2016
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 ................................................................................................................................................................... 4

6.5 Tubing ............................................................................................................................................................................................................. 5

6.6 Filter for blood and blood components ............................................................................................................................. 5

6.7 Drip chamber and drip tube ........................................................................................................................................................ 5

6.8 Flow regulator ......................................................................................................................................................................................... 5

6.9 Flow rate of blood and blood components ..................................................................................................................... 5

6.10 Injection site .............................................................................................................................................................................................. 6

6.11 Male conical fitting .............................................................................................................................................................................. 6

6.12 Protective caps ........................................................................................................................................................................................ 6

6.13 Storage volume ....................................................................................................................................................................................... 6

7 Chemical requirements ................................................................................................................................................................................. 6

7.1 Reducing (oxidizable) matter ..................................................................................................................................................... 6

7.2 Metal ions .................................................................................................................................................................................................... 6

7.3 Titration acidity or alkalinity...................................................................................................................................................... 6

7.4 Residue on evaporation ................................................................................................................................................................... 6

7.5 UV absorption of extract solution ........................................................................................................................................... 7

8 Biological requirements ............................................................................................................................................................................... 7

8.1 General ........................................................................................................................................................................................................... 7

8.2 Sterility .......................................................................................................................................................................................................... 7

8.3 Pyrogenicity ............................................................................................................................................................................................... 7

8.4 Haemolysis ................................................................................................................................................................................................. 7

8.5 Toxicity ........................................................................................................................................................................................................... 7

8.6 Assessment of blood component depletion ................................................................................................................... 7

8.7 Assessment of damage to blood components .............................................................................................................. 7

9 Labelling ........................................................................................................................................................................................................................ 8

9.1 General ........................................................................................................................................................................................................... 8

9.2 Unit container .......................................................................................................................................................................................... 8

9.3 Shelf or multi-unit container ...................................................................................................................................................... 9

10 Packaging ..................................................................................................................................................................................................................... 9

11 Disposal .......................................................................................................................................................................................................................... 9

Annex A (normative) Physical tests ....................................................................................................................................................................10

Annex B (normative) Chemical tests .................................................................................................................................................................14

Annex C (normative) Biological tests ................................................................................................................................................................16

Annex D (normative) Storage volume ..............................................................................................................................................................17

Bibliography .............................................................................................................................................................................................................................20

© ISO 2015 – All rights reserved iii
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SIST EN ISO 1135-5:2016
ISO 1135-5:2015(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 first edition of ISO 1135-5, together with ISO 1135-4, cancels and replaces ISO 1135-4:2012, which

has been technically revised with the following changes:

— the scope of ISO 1135-4 has been restricted to gravity feed applications, whereby, ISO 1135-5 is

focused on pressure infusion applications;
— a new Annex D on ‘Storage volume’ has been added.

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 1135-5:2016
INTERNATIONAL STANDARD ISO 1135-5:2015(E)
Transfusion equipment for medical use —
Part 5:
Transfusion sets for single use with pressure infusion
apparatus
1 Scope

This part of ISO 1135 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 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 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 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.

ISO 594-1 , Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical

equipment — Part 1: General requirements

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 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
---------------------- Page: 13 ----------------------
SIST EN ISO 1135-5:2016
ISO 1135-5:2015(E)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
NOTE These terms and definitions are specifically applicable to Annex D.
3.1
filling volume
volume of tube during “pressure less” filling, respectively filling by gravity
Note 1 to entry: The tube remains unstressed.

Note 2 to entry: The filling volume is to be equated with the calculated volume of the tube.

3.2
storage volume

tube volume during pressurization equal to filling volume, V , plus bolus volume, V : V = V +V

F S S F B
3.3
bolus volume

increased tube volume during pressurization (storage volume, V ) in comparison with the unstressed

tube (filling volume, V )
Note 1 to entry: For illustration of the bolus volume, see Figure 1.
Key
1 patient 4 bolus volume
2 occlusion 5 syringe pump
3 tube
Figure 1 — Bolus volume
4 General requirements
4.1 Nomenclature for components of the transfusion set
The nomenclature for components of transfusion sets is given in Figure 2.
2 © ISO 2015 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 1135-5:2016
ISO 1135-5:2015(E)
Key
1 protective cap of the closure-piercing device 8 flow regulator
2 closure-piercing device 9 injection site
3 fluid channel 10 male conical fitting
4 drip tube 11 protective cap of the male conical fitting
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.
6 filter for blood and blood components Injection site is optional.
7 tubing
Figure 2 — Example of a transfusion set
4.2 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.
5 Materials

The materials from which the transfusion sets given in Clause 4 are manufactured shall comply with the

requirements specified in Clause 6. If components of the transfusion set come into contact with blood

and blood components, they shall additionally comply with the requirements specified in Clauses 7 and 8.

© ISO 2015 – All rights reserved 3
---------------------- Page: 15 ----------------------
SIST EN ISO 1135-5:2016
ISO 1135-5:2015(E)
6 Physical requirements
6.1 Particulate contamination

The transfusion sets shall be manufactured under conditions that minimize particulate contamination.

All parts shall be smooth and c
...

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