EN ISO 1135-4:2010

SLOVENSKI STANDARD
01-september-2010
1DGRPHãþD
SIST EN ISO 1135-4:2005
Transfuzijska oprema za uporabo v medicini - 4. del: Transfuzijske garniture za
enkratno uporabo (ISO 1135-4:2010)
Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO
1135-4:2010)
Transfusionsgeräte zur medizinischen Verwendung - Teil 4: Transfusionsgeräte zur
einmaligen Verwendung (ISO 1135-4:2010)
Matériel de transfusion à usage médical - Partie 4: Appareils de transfusion non
réutilisables (ISO 1135-4:2010)
Ta slovenski standard je istoveten z: EN ISO 1135-4:2010
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
April 2010
ICS 11.040.20 Supersedes EN ISO 1135-4:2004
English Version
Transfusion equipment for medical use - Part 4: Transfusion
sets for single use (ISO 1135-4:2010)
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-
4:2010) 4:2010)
This European Standard was approved by CEN on 22 March 2010.

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 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 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 and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 1135-4:2010: 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 1135-4:2010) 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 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 October 2010, and conflicting national standards shall be withdrawn at
the latest by October 2010.
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 1135-4:2004.
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 and the United Kingdom.
Endorsement notice
The text of ISO 1135-4:2010 has been approved by CEN as a EN ISO 1135-4:2010 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 International 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 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.

Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC

Clause(s)/sub-clause(s) of Essential Requirements Qualifying remarks/Notes
this European Standard (ERs) 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
5.10 8
5.11 9.1
5.12 8
6 7
Presumption of conformity with the Essential
7.1 7, 7.5
Requirements relating to the biological
evaluation can only be provided if the
manufacturer chooses to apply the EN ISO
10993 series of 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
8 13
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
Fourth edition
2010-04-15
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 1135-4:2010(E)
©
ISO 2010
ISO 1135-4:2010(E)
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ISO 1135-4:2010(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.3
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.
...