SIST 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
2
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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.
3
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SIST EN ISO 8362-1:2019
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SIST EN ISO 8362-1:2019
INTERNATIONAL ISO
STANDARD 8362-1
Fourth edition
2018-08
Injection containers and
accessories —
Part 1:
Injection vials made of glass tubing
Récipients et accessoires pour produits injectables —
Partie 1: Flacons en verre étiré
Reference number
ISO 8362-1:2018(E)
©
ISO 2018
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SIST EN ISO 8362-1:2019
ISO 8362-1:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
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SIST EN ISO 8362-1:2019
ISO 8362-1:2018(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Dimensions . 1
5 Designation . 5
6 Material . 5
7 Performance . 6
8 Requirements . 6
8.1 Hydrolytic resistance . 6
8.2 Annealing quality . 6
9 Marking . 6
Bibliography . 7
© ISO 2018 – All rights reserved iii
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SIST EN ISO 8362-1:2019
ISO 8362-1:2018(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso
.org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection
equipment for medical and pharmaceutical use.
This fourth edition cancels and replaces the third edition (ISO 8362-1:2009), which has been
...
SLOVENSKI STANDARD
oSIST prEN ISO 8362-1:2019
01-julij-2019
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: prEN ISO 8362-1
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
oSIST prEN ISO 8362-1:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 8362-1:2019
---------------------- Page: 2 ----------------------
oSIST prEN ISO 8362-1:2019
INTERNATIONAL ISO
STANDARD 8362-1
Fourth edition
2018-08
Injection containers and
accessories —
Part 1:
Injection vials made of glass tubing
Récipients et accessoires pour produits injectables —
Partie 1: Flacons en verre étiré
Reference number
ISO 8362-1:2018(E)
©
ISO 2018
---------------------- Page: 3 ----------------------
oSIST prEN ISO 8362-1:2019
ISO 8362-1:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 8362-1:2019
ISO 8362-1:2018(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Dimensions . 1
5 Designation . 5
6 Material . 5
7 Performance . 6
8 Requirements . 6
8.1 Hydrolytic resistance . 6
8.2 Annealing quality . 6
9 Marking . 6
Bibliography . 7
© ISO 2018 – All rights reserved iii
---------------------- Page: 5 ----------------------
oSIST prEN ISO 8362-1:2019
ISO 8362-1:2018(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso
.org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection
equipment for medical and pharmaceutical use.
This fourth edition cancels and replaces the third edition (ISO 8362-1:2009), which has been technically
revised.
The main changes compared to the previous edition are:
— add an alternative for a chamfer shaped with ≈45° in Figure 1;
— add a 3R format in Table 1.
A list of all parts in the ISO 8362 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2018 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 8362-1:2019
ISO 8362-1:2018(E)
Introduction
The purpose of this document is to specify the dimensions, capacities, form and requirements of glass
vials intended for medical use. Containers made from glass tubing are considered to be suitable for the
packaging and storage of injectable preparations until they are administered for medicinal purposes.
Such containers may be made from different types of glass which can affect the chemical resistance
properties; e.g., those made from borosilicate glass will have a very high level of chemical resistance
whereas others made from soda-lime glass will have a lower, but adequate, chemical resistance for the
purpose for which they are intended. The chemical resistance of the internal surface of containers made
from soda-lime glass can be improved by means of a treatment during production aimed at producing
a chemical resistance equal to that of those made from borosilicate glass for single use. This level of
chemical resistance is maintained as long as the interior surface is not destroyed by chemical attack, in
which case it is reduced to that of untreated soda-lime glass.
Because containers may be made from different types of glass and because it is the chemical behaviour
of the internal surface which is important when they are filled with injectable preparations, it is
essential to specify test procedures by which this performance can be measured. The procedures
recommended in this document permit this p
...
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