EN ISO 8362-1:2019
(Main)Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO 8362-1:2018)
Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO 8362-1:2018)
This document specifies the form, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers are made and the performance requirements of those containers.
This document is applicable to colourless or amber glass containers made from borosilicate or soda-lime glass, made from glass tubing, whether internally surface-treated or not, and intended to be used in the packaging, storage or transportation of products intended for injection.
Injektionsbehältnisse und Zubehör - Teil 1: Injektionsflaschen aus Röhrenglas (ISO 8362-1:2018)
Dieses Dokument legt die Form, Maße und Inhaltsmengen für Glasbehältnisse für Injektionspräparate fest. Es legt auch die Werkstoffe fest, aus denen diese Behältnisse hergestellt werden, sowie die Leistungsanforderungen für diese Behältnisse.
Dieses Dokument gilt für farblose oder braune Röhrenglasbehältnisse aus Borosilicatglas oder Kalk-Natronglas mit oder ohne Behandlung der Innenoberfläche, die für die Verpackung, Aufbewahrung oder den Transport von Injektionspräparaten verwendet werden.
Récipients et accessoires pour produits injectables - Partie 1: Flacons en verre étiré (ISO 8362-1:2018)
Le présent document spécifie la forme, les dimensions et les capacités des flacons en verre pour préparations injectables. Il spécifie également le matériau constitutif de ces flacons et les exigences de performance relatives à ces récipients.
Le présent document est applicable aux récipients en verre blanc ou ambré, en verre borosilicaté ou en verre de silicate sodocalcique, obtenus à partir de verre étiré, avec une surface interne traitée ou non, conçus pour l'emballage, le stockage ou le transport des produits injectables.
Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 1. del: Viale iz cevnega stekla (ISO 8362-1:2018)
Ta dokument določa obliko, mere in prostornino steklenih vial za pripravke za injiciranje. Določa tudi material, iz katerega so ti vsebniki izdelani, in zahteve glede njihovih lastnosti. Uporablja se za brezbarvne steklene vsebnike oziroma steklene vsebnike jantarne barve, izdelane iz borosilikatnega ali natrij-kalcijevega stekla na osnovi steklenih cevk, z obdelano notranjo površino ali brez obdelave, ki se uporabljajo pri pakiranju, shranjevanju ali prevozu proizvodov, namenjenih injiciranju.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8362-1:2019
01-december-2019
Nadomešča:
SIST EN ISO 8362-1:2010
SIST EN ISO 8362-1:2010/A1:2016
Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 1. del: Viale iz
cevnega stekla (ISO 8362-1:2018)
Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO
8362-1:2018)
Injektionsbehältnisse und Zubehör - Teil 1: Injektionsflaschen aus Röhrenglas (ISO 8362
-1:2018)
Récipients et accessoires pour produits injectables - Partie 1: Flacons en verre étiré (ISO
8362-1:2018)
Ta slovenski standard je istoveten z: EN ISO 8362-1:2019
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8362-1:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8362-1:2019
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SIST EN ISO 8362-1:2019
EN ISO 8362-1
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2019
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 8362-1:2009
English Version
Injection containers and accessories - Part 1: Injection
vials made of glass tubing (ISO 8362-1:2018)
Récipients et accessoires pour produits injectables - Injektionsbehältnisse und Zubehör - Teil 1:
Partie 1: Flacons en verre étiré (ISO 8362-1:2018) Injektionsflaschen aus Röhrenglas (ISO 8362-1:2018)
This European Standard was approved by CEN on 5 August 2019.
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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8362-1:2019 E
worldwide for CEN national Members.
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SIST EN ISO 8362-1:2019
EN ISO 8362-1:2019 (E)
Contents Page
European foreword . 3
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SIST EN ISO 8362-1:2019
EN ISO 8362-1:2019 (E)
European foreword
The text of ISO 8362-1:2018 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 8362-1:2019 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 April 2020, and conflicting national standards shall be
withdrawn at the latest by April 2020.
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 8362-1:2009.
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 8362-1:2018 has been approved by CEN as EN ISO 8362-1:2019 without any
modification.
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SIST EN ISO 8362-1:2019
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SIST EN ISO 8362-1:2019
INTERNAT
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