EN ISO 1135-4:2012

Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2012)

ISO 1135-4:2011 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.
Secondary aims of ISO 1135-4:2011 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets and to present designations for transfusion set components.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-4:2011.

Transfusionsgeräte zur medizinischen Verwendung - Teil 4: Transfusionsgeräte zur einmaligen Verwendung (ISO 1135-4:2012)

Matériel de transfusion à usage médical - Partie 4: Appareils de transfusion non réutilisables (ISO 1135-4:2012)

L'ISO 1135-4:2012 spécifie les exigences applicables aux appareils de transfusion à usage médical, non réutilisables, afin d'assurer leur compatibilité avec les conteneurs renfermant du sang et des composants du sang, ainsi qu'avec les appareils intraveineux.
Les objectifs secondaires de l'ISO 1135-4:2012 sont de donner des lignes directrices sur les spécifications relatives à la qualité et aux performances des matériaux utilisés dans les appareils de transfusion, et de proposer une terminologie relative aux composants de ces derniers.
Dans certains pays, la pharmacopée nationale ou d'autres réglementations nationales sont légalement contraignantes et priment sur l'ISO 1135-4:2012.

Transfuzijska oprema za uporabo v medicini - 4. del: Transfuzijske garniture za enkratno uporabo (ISO 1135-4:2012)

Ta del standarda ISO 1135 določa zahteve za transfuzijske garniture za enkratno uporabo v medicini, 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, ter predstaviti oznake za sestavne dele transfuzijskih garnitur. V nekaterih državah je nacionalna farmakopeja ali druga nacionalna zakonodaja pravno zavezujoča in ima prednost pred tem delom standarda ISO 1135.

General Information

• Status: Withdrawn
• Publication Date: 29-Feb-2012
• Withdrawal Date: 22-Dec-2015
• 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: 9960 - Withdrawal effective - Withdrawal
• 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 1135-4:2012 - Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2012)

Relations

• Replaces: EN ISO 1135-4:2011 - Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2010)
• Effective Date: 08-Oct-2011
• Replaced By: EN ISO 1135-4:2015 - Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015)
• Effective Date: 08-Jun-2022
• Replaced By: 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)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2012
1DGRPHãþD
Transfuzijska oprema za uporabo v medicini - 4. del: Transfuzijske garniture za
enkratno uporabo (ISO 1135-4:2012)
Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO
1135-4:2012)
Transfusionsgeräte zur medizinischen Verwendung - Teil 4: Transfusionsgeräte zur
einmaligen Verwendung (ISO 1135-4:2012)
Matériel de transfusion à usage médical - Partie 4: Appareils de transfusion non
réutilisables (ISO 1135-4:2012)
Ta slovenski standard je istoveten z: EN ISO 1135-4:2012
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
March 2012
ICS 11.040.20 Supersedes EN ISO 1135-4:2011
English Version
Transfusion equipment for medical use - Part 4: Transfusion
sets for single use (ISO 1135-4:2012)
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-
4:2012) 4:2012)
This European Standard was approved by CEN on 29 February 2012.

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, 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

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 1135-4:2012: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .4

Foreword
This document (EN ISO 1135-4:2012) 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 September 2012, and conflicting national standards shall be
withdrawn at the latest by September 2012.
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.
This document supersedes EN ISO 1135-4:2010.
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.
For relationship with EU Directive, 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, 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 1135-4:2012 has been approved by CEN as a EN ISO 1135-4:2012 without any modification.
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 on medical devices.
Once this standard is cited in the Official Journal of the European Communities 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.
Table ZA.1 — Correspondence between this European Standard and
Directive 93/42/EEC on medical devices
Essential Requirements (ERs) of
Clause(s)/sub-clause(s) of this EN Qualifying remarks/Notes
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
5.10 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
Table ZA.1 (continued)
Essential Requirements (ERs) of
Clause(s)/sub-clause(s) of this EN Qualifying remarks/Notes
Directive 93/42/EEC
7.5 7.1, 7.2
8 13 The part of 13.3.a) relating to the
authorized representative is not
addressed. 13.3.f) and 13.6.h)
relating to single use are not fully
addressed. 13.6.q) is not addressed.
9 5, 8.3
10 13.6 n)
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
INTERNATIONAL ISO
STANDARD 1135-4
Fifth edition
2012-03-01
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 1135-4:2012(E)
©
ISO 2012
ISO 1135-4:2012(E)
©  ISO 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
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ii © ISO 2012 – All rights reserved

ISO 1135-4:2012(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
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
8  Labelling . 6
8.1  Unit container . 6
8.2  Shelf or multi-unit container . 7
9  Packaging . 7
10  Disposal . 7
Annex A (normative) Physical tests . 8
Annex B (normative) Chemical tests .
...