EN ISO 22413:2013
(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 se uporablja za steriliziran pribor za prenos za enkratno uporabo, ki se uporablja za farmacevtske pripravke.
General Information
Relations
Standards Content (Sample)
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
2
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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, Ice
...
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