EN ISO 8362-2:2015/A1:2022
(Amendment)Injection containers and accessories - Part 2: Closures for injection vials - Amendment 1 (ISO 8362-2:2015/Amd 1:2022)
Injection containers and accessories - Part 2: Closures for injection vials - Amendment 1 (ISO 8362-2:2015/Amd 1:2022)
Injektionsbehältnisse und Zubehör - Teil 2: Stopfen für Injektionsflaschen - Änderung 1 (ISO 8362-2:2015/Amd 1:2022)
Récipients et accessoires pour produits injectables - Partie 2: Bouchons pour flacons - Amendement 1 (ISO 8362-2:2015/Amd 1:2022)
Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 2. del: Zapirala za viale - Dopolnilo A1 (ISO 8362-2:2015/Amd 1:2022)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2022
Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 2. del: Zapirala
za viale - Dopolnilo A1 (ISO 8362-2:2015/Amd 1:2022)
Injection containers and accessories - Part 2: Closures for injection vials - Amendment 1
(ISO 8362-2:2015/Amd 1:2022)
Injektionsbehältnisse und Zubehör - Teil 2: Stopfen für Injektionsflaschen - Änderung 1
(ISO 8362-2:2015/Amd 1:2022)
Récipients et accessoires pour produits injectables - Partie 2: Bouchons pour flacons -
Amendement 1 (ISO 8362-2:2015/Amd 1:2022)
Ta slovenski standard je istoveten z: EN ISO 8362-2:2015/A1:2022
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.
EN ISO 8362-2:2015/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2022
EUROPÄISCHE NORM
ICS 11.040.20
English Version
Injection containers and accessories - Part 2: Closures for
injection vials - Amendment 1 (ISO 8362-2:2015/Amd
1:2022)
Récipients et accessoires pour produits injectables - Injektionsbehältnisse und Zubehör - Teil 2: Stopfen für
Partie 2: Bouchons pour flacons - Amendement 1 (ISO Injektionsflaschen - Änderung 1 (ISO 8362-
8362-2:2015/Amd 1:2022) 2:2015/Amd 1:2022)
This amendment A1 modifies the European Standard EN ISO 8362-2:2015; it was approved by CEN on 16 May 2022.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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, Türkiye 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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8362-2:2015/A1:2022 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 8362-2:2015/A1:2022) 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/SS S02 “Transfusion equipment” the secretariat of
which is held by CCMC.
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 March 2023, and conflicting national standards shall
be withdrawn at the latest by March 2023.
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.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 8362-2:2015/Amd 1:2022 has been approved by CEN as EN ISO 8362-2:2015/A1:2022
without any modification.
INTERNATIONAL ISO
STANDARD 8362-2
Third edition
2015-10-01
AMENDMENT 1
2022-08
Injection containers and
accessories —
Part 2:
Closures for injection vials
AMENDMENT 1
Récipients et accessoires pour produits injectables —
Partie 2: Bouchons pour flacons
AMENDEMENT 1
Reference number
ISO 8362-2:2015/Amd.1:2022(E)
SIST EN ISO 8362-2:2016/A1:2
...
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