SIST EN ISO 22413:2013

SLOVENSKI STANDARD
SIST EN ISO 22413:2013
01-maj-2013
1DGRPHãþD
SIST EN ISO 22413:2011
Pribor za prenos farmacevtskih pripravkov - Zahteve in preskusne metode (ISO
22413:2010)
Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO
22413:2010)
Überleitgeräte für pharmazeutische Zubereitungen - Anforderungen und Prüfverfahren
(ISO 22413:2010)
Ensemble de transfert pour préparations pharmaceutiques - Exigences et méthodes
d'essai (ISO 22413:2010)
Ta slovenski standard je istoveten z: EN ISO 22413:2013
ICS:
11.120.99 Drugi standardi v zvezi s Other standards related to
farmacijo pharmaceutics
SIST EN ISO 22413:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 22413:2013

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SIST EN ISO 22413:2013


EUROPEAN STANDARD
EN ISO 22413

NORME EUROPÉENNE

EUROPÄISCHE NORM
February 2013
ICS 11.040.20 Supersedes EN ISO 22413:2011
English Version
Transfer sets for pharmaceutical preparations - Requirements
and test methods (ISO 22413:2010)
Ensemble de transfert pour préparations pharmaceutiques Überleitgeräte für pharmazeutische Zubereitungen -
- Exigences et méthodes d'essai (ISO 22413:2010) Anforderungen und Prüfverfahren (ISO 22413:2010)
This European Standard was approved by CEN on 8 January 2013.

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

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22413:2013: E
worldwide for CEN national Members.

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SIST EN ISO 22413:2013
EN ISO 22413:2013 (E)
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


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SIST EN ISO 22413:2013
EN ISO 22413:2013 (E)
Foreword
The text of ISO 22413:2010 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and
injection, and blood processing equipment for medical and pharmaceutical use” of the International
Organization for Standardization (ISO) and has been taken over as EN ISO 22413:2013 by 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 August 2013, and conflicting national standards shall be withdrawn at
the latest by August 2013.
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 22413:2011.
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, 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 22413:2010 has been approved by CEN as EN ISO 22413:2013 without any modification.
3

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SIST EN ISO 22413:2013
EN ISO 22413:2013 (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 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 on medical devices
Clause(s)/subclause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
5.1, 5.12, 6 7.2
6, 7 7.3
Presumption of conformity with
the Essential Requirements
relating to biological evaluation
can only be provided if the
manufacturer chooses to apply
the EN ISO 10993 series of
standards, as proposed in the
normative reference
EN ISO 8536-4.
7 7.5 Presumption of conformity with
the Essential Requirements
relating to biological evaluation
can only be provided if the
manufacturer chooses to apply
the EN ISO 10993 series of
standards, as proposed in the
normative reference
EN ISO 8536-4.
5.3, 5.5, 5.7 7.6
5.8, 7 8.1 Presumption of conformity with
the Essential Requirements
relating to biological evaluation
can only be provided if the
manufacturer chooses to apply
the EN ISO 10993 series of
standards, as proposed in the
normative reference
EN ISO 8536-4.
4

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SIST EN ISO 22413:2013
EN ISO 22413:2013 (E)

Clause(s)/subclause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
5.9, 11, 12 8.3
7 8.4 Presumption of conformity with
the Essential Requirements
relating to biological evaluation
can only be provided if the
manufacturer chooses to apply
the EN ISO 10993 series of
standards, as proposed in the
normative reference
EN ISO 8536-4.
5.2, 5.6, 5.11 9.1
5.10.2 9.2
5.2, 5.6 12.7.1
5.4 12.8.1
13 13.3 The part of 13.3 a) relating to the
authorized representatives is not
addressed.
ERs 13.3 c) relating to the
symbol STERILE and 13.3 f)
relating to single-use are not
fully addressed.
3.3 13.3 (b)

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
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SIST EN ISO 22413:2013

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SIST EN ISO 22413:2013

INTERNATIONAL ISO
STANDARD 22413
Second edition
2010-06-15


Transfer sets for pharmaceutical
preparations — Requirements and test
methods
Ensemble de transfert pour préparations pharmaceutiques —
Exigences et méthodes d'essai





Reference number
ISO 22413:2010(E)
©
ISO 2010

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SIST EN ISO 22413:2013
ISO 22413:2010(E)
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ii © ISO 2010 – All rights reserved

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SIST EN ISO 22413:2013
ISO 22413:2010(E)
Contents Page
Foreword .v
Introduction.vi
1 Scope.1
2 Normative references.1
3 Design and designation.1
3.1 Design.1
3.2 Design for a transfer set with housing.4
3.3 Designation .4
4 Material .4
5 Physical requirements .5
5.1 Particulate contamination.5
5.2 Tensile strength.5
5.3 Tightness.5
5.4 Free flow.5
5.5 Piercing device .5
5.6 Penetration force .5
5.7 Fragmentation.6
5.8 Air inlet and air outlet.6
5.9 Protective caps .6
5.10 Transfer sets with a housing.6
5.11 Luer connector .6
5.12 Filter for particles .6
6 Chemical requirements.6
7 Biological requirements.6
8 Testing of physical requirements .6
8.1 Particulate contamination.6
8.2 Tensile strength.7
8.3 Tightness of transfer set.7
8.4 Free flow.7
8.5 Piercing device .7
8.6 Penetration force .7
8.7 Testing on fragmentation .7
8.8 Effectiveness of air inlet and air outlet with air filter.7
8.9 Efficiency of protective caps.7
8.10 Luer connector .7
8.11 Filter for particles .7
9 Testing of chemical requirements .8
10 Testing of biological requirements.8
11 Packaging.8
12 Storage .8
13 Labelling.8
13.1 Unit container .8
13.2 Shelf or multi-unit container .8
Annex A (normative) Testing of fragmentation of transfer sets with plastic piercing devices .9
© ISO 2010 – All rights reserved iii

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SIST EN ISO 22413:2013
ISO 22413:2010(E)
Annex B (normative) Testing of fragmentation of transfer sets with metal piercing devices .11
Bibliography .13

iv © ISO 2010 – All rights reserved

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SIST EN ISO 22413:2013
ISO 22413:2010(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 22413 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment
for medical and pharmaceutical use.
This second edition cancels and replaces the first edition (ISO 22413:2007), of which the scope was
enhanced by introducing further product groups like transfer sets with integrated Luer connectors and particle
filters. In that framework the following major changes were introduced:
⎯ the Introduction was amended by h) and j);
⎯ the Normative references were updated;
⎯ the Figures in 3.1 were updated;
⎯ 5.11 and 8.10 on the physical requirements and testing for Luer connector were added;
⎯ 5.12 and 8.11 on the physical requirements and testing for filter for particles were added.
© ISO 2010 – All rights reserved v

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SIST EN ISO 22413:2013
ISO 22413:2010(E)
Introduction
Transfer sets for pharmaceutical preparations transmit fluids from one container to another. The transfer sets
mix fluids or dissolve dry substances and are u
...