EN ISO 22413:2011
(Main)Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2010)
Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2010)
ISO 22413:2010 applies to sterilized single use transfer sets that are used for pharmaceutical preparations.
Überleitgeräte für pharmazeutische Zubereitungen - Anforderungen und Prüfverfahren (ISO 22413:2010)
Diese Internationale Norm gilt für sterilisierte, zur einmaligen Verwendung bestimmte Überleitgeräte für pharmazeutische Zubereitungen.
Ensemble de transfert pour préparations pharmaceutiques - Exigences et méthodes d'essai (ISO 22413:2010)
L'ISO 22413:2010 s'applique aux ensembles de transfert stérilisés, non réutilisables, utilisés pour les préparations pharmaceutiques.
Pribor za prenos farmacevtskih pripravkov - Zahteve in preskusne metode (ISO 22413:2010)
Ta mednarodni standard velja za steriliziran pribor za enkratno uporabo, ki se uporablja za prenos farmacevtskih pripravkov.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-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 22413:2011
ICS:
11.120.99 Drugi standardi v zvezi s Other standards related to
farmacijo pharmaceutics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 22413
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2011
ICS 11.040.20
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 5 May 2011.
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 and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22413:2011: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EC Directive 93/42/EEC on medical devices .4
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 22413:2011 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 December 2011, and conflicting national standards shall be withdrawn
at the latest by December 2011.
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 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, 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 22413:2010 has been approved by CEN as a EN ISO 22413:2011 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EC 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)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
3.3 13.3 (b)
4 1, 2, 3
5.1 7.2
5.2 9.1, 12.7.1
5.3 7.6
5.4 12.8.1
5.5 7.6
5.6 9.1, 12.7.1
5.7 7.6
5.8 8.1
5.9 8.3
5.10.2 9.2
5.11 9.1
5.12 7.2
6 7.1, 7.2, 7.3
7 7.3, 7.5, 8.1, 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
standard, as proposed in the
normative reference EN ISO
8536-4.
Table ZA.1 (continued)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs)
Qualifying remarks/Notes
EN of Directive 93/42/EEC
11 5, 8.3
12 5, 8.3
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.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
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
ISO 22413:2010(E)
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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 .
...
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