EN ISO 8362-1:2009/A1:2015
(Amendment)Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO 8362-1:2009/Amd 1:2015)
Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO 8362-1:2009/Amd 1:2015)
2014-03-27 EMA: Draft for // ENQ received in ISO/CS (see notification of 2014-03-26 in dataservice).
Injektionsbehältnisse und Zubehör - Teil 1: Injektionsflaschen aus Röhrenglas (ISO 8362-1:2009/Amd 1:2015)
Dieser Teil von ISO 8362 legt die Formen, Maße und Inhaltsmengen für Glasbehältnisse für Injektions¬präparate fest. Er legt auch die Werkstoffe fest, aus denen diese Behältnisse hergestellt werden müssen, sowie die Leistungsanforderungen für diese.
Dieser Teil von ISO 8362 gilt für farblose oder braune Röhrenglasbehältnisse aus Borosilicatglas oder Alkali-Kalkglas mit oder ohne Behandlung der Innenoberfläche, die für die Verpackung, Aufbewahrung oder den Transport von Injektionspräparaten verwendet werden sollen.
Récipients et accessoires pour produits injectables - Partie 1: Flacons en verre étiré (ISO 8362-1:2009/Amd 1:2015)
Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 1. del: Viale iz cevnega stekla (ISO 8362-1:2009/Amd 1:2015)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2016
Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 1. del: Viale iz
cevnega stekla (ISO 8362-1:2009/Amd 1:2015)
Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO
8362-1:2009/Amd 1:2015)
Injektionsbehältnisse und Zubehör - Teil 1: Injektionsflaschen aus Röhrenglas (ISO 8362
-1:2009/Amd 1:2015)
Récipients et accessoires pour produits injectables - Partie 1: Flacons en verre étiré (ISO
8362-1:2009/Amd 1:2015)
Ta slovenski standard je istoveten z: EN ISO 8362-1:2009/A1:2015
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 8362-1:2009/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2015
EUROPÄISCHE NORM
ICS 11.040.20
English Version
Injection containers and accessories - Part 1: Injection
vials made of glass tubing (ISO 8362-1:2009/Amd 1:2015)
Récipients et accessoires pour produits injectables - Injektionsbehältnisse und Zubehör - Teil 1:
Partie 1: Flacons en verre étiré (ISO 8362-1:2009/Amd Injektionsflaschen aus Röhrenglas (ISO 8362-
1:2015) 1:2009/Amd 1:2015)
This amendment A1 modifies the European Standard EN ISO 8362-1:2009; it was approved by CEN on 3 October 2015.
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, 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
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8362-1:2009/A1:2015 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 8362-1:2009/A1:2015) has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical
use".
This Amendment to the European Standard EN ISO 8362-1:2009 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by June 2016, and
conflicting national standards shall be withdrawn at the latest by June 2016.
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.
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 8362-1:2009/Amd 1:2015 has been approved by CEN as EN ISO 8362-1:2009/A1:2015
without any modification.
INTERNATIONAL ISO
STANDARD 8362-1
Third edition
2009-12-15
AMENDMENT 1
2015-12-15
Injection containers and
accessories —
Part 1:
Injection vials
...
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