EN ISO 1135-4:2004

Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2004)

Specifies dimensions and performance of single use transfusion sets for use in transfusing human blood

Transfusionsgeräte zur medizinischen Verwendung - Teil 4: Transfusionsgeräte zur einmaligen Verwendung (ISO 1135-4:2004)

Dieser Teil von ISO 1135 legt Anforderungen an zur einmaligen Verwendung bestimmte medizinische Transfusionsgeräte fest, um sicherzustellen, dass sie zur Verwendung mit Behältnissen für Blut und Blutbestandteile und Geräten zur intravenösen Punktion geeignet sind.
Diese Norm legt auch Anforderungen an Belüftungsteile fest, die zusammen mit starren Behältern für Blut und Blutbestandteile verwendet werden.
Diese Norm enthält auch Festlegungen bezüglich Qualität und Leistungsfähigkeit der Werkstoffe, die für Transfusionsgeräte verwendet werden. Außerdem werden Benennungen für die Einzelteile von Transfusionsgeräten angegeben.
In einigen Ländern sind das nationale Arzneibuch oder andere nationale Bestimmungen rechtlich bindend und haben Vorrang vor dieser Norm.

Matériel de transfusion à usage médical - Partie 4: Appareils de transfusion non réutilisables (ISO 1135-4:2004)

Transfuzijska oprema za uporabo v medicini – 4. del: Transfuzijske garniture za enkratno uporabo (ISO 1135-4:2004)

General Information

• Status: Withdrawn
• Publication Date: 14-Jul-2004
• Withdrawal Date: 14-Apr-2010
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 11 - Transfusion, infusion and injection equipment
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 15-Apr-2010
• Completion Date: 15-Apr-2010
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 1135-4:2005 - Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2004)

Relations

• Replaced By: EN ISO 1135-4:2010 - Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2010)
• Effective Date: 24-Apr-2010

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2005
Transfuzijska oprema za uporabo v medicini – 4. del: Transfuzijske garniture za
enkratno uporabo (ISO 1135-4:2004)
Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO
1135-4:2004)
Transfusionsgeräte zur medizinischen Verwendung - Teil 4: Transfusionsgeräte zur
einmaligen Verwendung (ISO 1135-4:2004)
Matériel de transfusion a usage médical - Partie 4: Appareils de transfusion non
réutilisables (ISO 1135-4:2004)
Ta slovenski standard je istoveten z: EN ISO 1135-4:2004
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 1135-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2004
ICS 11.040.20
English version
Transfusion equipment for medical use - Part 4: Transfusion
sets for single use (ISO 1135-4:2004)
Matériel de transfusion à usage médical - Partie 4: Transfusionsgeräte zur medizinischen Verwendung - Teil 4:
Appareils de transfusion non réutilisables (ISO 1135- Transfusionsgeräte zur einmaligen Verwendung (ISO 1135-
4:2004) 4:2004)
This European Standard was approved by CEN on 22 June 2004.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 1135-4:2004: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 1135-4:2004) has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection equipment for medical and pharmaceutical use" in
collaboration with Technical Committee CEN/TC 205 "Non-active medical devices", the
secretariat of which is held by BSI.

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 January 2005, and conflicting national
standards shall be withdrawn at the latest by January 2005.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

Endorsement notice
The text of ISO 1135-4:2004 has been approved by CEN as EN ISO 1135-4:2004 without any
modifications.
INTERNATIONAL ISO
STANDARD 1135-4
Third edition
2004-07-15
Transfusion equipment for medical use —
Part 4:
Transfusion sets for single use
Matériel de transfusion à usage médical —
Partie 4: Appareils de transfusion non réutilisables

Reference number
ISO 1135-4:2004(E)
©
ISO 2004
ISO 1135-4:2004(E)
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©
ii ISO 2004 – All rights reserved

ISO 1135-4:2004(E)
Contents Page
1 Scope . 1
2 Normative references . 1
3 General requirements . 1
3.1 Nomenclature for components of the transfusion set . 1
3.2 Maintenance of sterility . 3
3.3 Designation . 3
4 Materials . 4
5 Physical requirements . 4
5.1 Particulate contamination . 4
5.2 Leakage . 4
5.3 Tensile strength . 4
5.4 Closure-piercing device . 4
5.5 Air-inlet device . 5
5.6 Tubing . 5
5.7 Filter for blood and blood components . 5
5.8 Drip chamber and drip tube . 5
5.9 Flow regulator . 5
5.10 Flow rate of blood and blood components . 5
5.11 Injection site . 6
5.12 Male conical fitting . 6
5.13 Protective caps . 6
6 Chemical requirements . 6
6.1 Reducing (oxidizable) matter . 6
6.2 Metal ions . 6
6.3 Titration acidity or alkalinity . 6
6.4 Residue on evaporation . 6
6.5 UV absorption of extract solution . 6
7 Biological requirements . 7
7.1 General . 7
7.2 Sterility . 7
7.3 Pyrogenicity . 7
7.4 Haemolysis . 7
7.5 Toxicity . 7
8 Labelling . 7
8.1 Unit container . 7
8.2 Shelf or multi-unit container . 8
9 Packaging . 8
Annex A (normative) Physical tests . 9
Annex B (normative) Chemical tests . 13
©
ISO 2004 – All rights reserved iii

ISO 1135-4:2004(E)
Annex C (normative) Biological tests . 15
Bibliography . 16
©
iv ISO 2004 – All rights reserved

ISO 1135-4:2004(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 1135-4 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for
medical and pharmaceutical use.
This third edition cancels and replaces the second edition (ISO 1135-4:1998), which has been technically
revised.
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
©
ISO 2004 – All rights reserved v

.
vi
INTERNATIONAL STANDARD ISO 1135-4:2004(E)
Transfusion equipment for medical use —
Part 4:
Transfusion sets for single use
1Scope
This part of ISO 1135 specifies requirements for single-use transfusion sets for medical use in order to ensure
their compatibility with containers for blood and blood components as well as with intravenous equipment.
This part of ISO 1135 also specifies requirements for air-inlet devices for use with rigid containers for blood and
blood components.
Secondary aims of this part of ISO 1135 are to provide guidance on specificat
...