EN ISO 22413:2021
(Main)Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2021)
Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2021)
This document specifies requirements and test methods for sterilized single-use transfer sets that are used for pharmaceutical preparations.
Überleitgeräte für pharmazeutische Zubereitungen - Anforderungen und Prüfverfahren (ISO 22413:2021)
Dieses Dokument legt Anforderungen und Prüfverfahren für sterilisierte, zur einmaligen Verwendung bestimmte Überleitgeräte für pharmazeutische Zubereitungen fest.
Ensemble de transfert pour préparations pharmaceutiques - Exigences et méthodes d'essai (ISO 22413:2021)
Le présent document spécifie les exigences et les méthodes d’essai relatives aux ensembles de transfert stérilisés, non réutilisables, utilisés pour les préparations pharmaceutiques.
Pribor za prenos farmacevtskih pripravkov - Zahteve in preskusne metode (ISO 22413:2021)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 22413:2021
01-september-2021
Nadomešča:
SIST EN ISO 22413:2013
Pribor za prenos farmacevtskih pripravkov - Zahteve in preskusne metode (ISO
22413:2021)
Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO
22413:2021)
Überleitgeräte für pharmazeutische Zubereitungen - Anforderungen und Prüfverfahren
(ISO 22413:2021)
Ensemble de transfert pour préparations pharmaceutiques - Exigences et méthodes
d'essai (ISO 22413:2021)
Ta slovenski standard je istoveten z: EN ISO 22413:2021
ICS:
11.120.99 Drugi standardi v zvezi s Other standards related to
farmacijo pharmaceutics
SIST EN ISO 22413:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 22413:2021
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SIST EN ISO 22413:2021
EN ISO 22413
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2021
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 22413:2013
English Version
Transfer sets for pharmaceutical preparations -
Requirements and test methods (ISO 22413:2021)
Ensemble de transfert pour préparations Überleitgeräte für pharmazeutische Zubereitungen -
pharmaceutiques - Exigences et méthodes d'essai (ISO Anforderungen und Prüfverfahren (ISO 22413:2021)
22413:2021)
This European Standard was approved by CEN on 23 April 2021.
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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22413:2021 E
worldwide for CEN national Members.
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SIST EN ISO 22413:2021
EN ISO 22413:2021 (E)
Contents Page
European foreword . 3
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SIST EN ISO 22413:2021
EN ISO 22413:2021 (E)
European foreword
This document (EN ISO 22413:2021) 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 December 2021, and conflicting national standards
shall be withdrawn at the latest by December 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 22413:2013.
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, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 22413:2021 has been approved by CEN as EN ISO 22413:2021 without any modification.
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SIST EN ISO 22413:2021
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SIST EN ISO 22413:2021
INTERNATIONAL ISO
STANDARD 22413
Third edition
2021-06
Transfer sets for pharmaceutical
...
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