EN ISO 8362-2:2024
(Main)Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2024)
Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2024)
This document specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this document are intended for single use only.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.
Injektionsbehältnisse und Zubehör - Teil 2: Stopfen für Injektionsflaschen (ISO 8362-2:2024)
Dieses Dokument legt die Form, die Maße, die Werkstoffe, die Leistungsanforderungen und die Kennzeichnung von Stopfen für Injektionsflaschen nach ISO8362-1 und ISO8362-4 fest.
Die maßlichen Anforderungen sind nicht anwendbar auf beschichtete Stopfen.
Die Stopfen nach diesem Dokument sind nur zum einmaligen Gebrauch bestimmt.
ANMERKUNG Die Wirksamkeit, Reinheit, Beständigkeit und Sicherheit eines Arzneimittels während seiner Herstellung und Lagerung können erheblich durch die Art und Ausführung des Primärpackmittels beeinträchtigt werden.
Récipients et accessoires pour produits injectables - Partie 2: Bouchons pour flacons (ISO 8362-2:2024)
Le présent document spécifie la forme, les dimensions, le matériau, les exigences de performances et l’étiquetage des bouchons de flacons pour produits injectables faisant l’objet de l’ISO 8362-1 et de l’ISO 8362-4.
Les exigences dimensionnelles ne s’appliquent pas aux bouchons avec revêtement protecteur.
Les bouchons faisant l’objet du présent document sont à usage unique seulement.
NOTE La nature et les performances de l’emballage primaire peuvent influer considérablement sur l’efficacité, la pureté, la stabilité et la sécurité d’un produit pharmaceutique au cours de sa fabrication et de son stockage.
Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 2. del: Zapirala za viale (ISO 8362-2:2024)
Standard ISO 8362-2:2015 določa obliko, dimenzije, material, zahtevane lastnosti in etiketiranje zapiral za viale, obravnavanih v standardih ISO 8362-1 in ISO 8362‑4.
Zahteve glede dimenzij ne veljajo za zapirala s pregrado.
Zapirala, določena v standardu ISO 8362-2:2015, so namenjena le za enkratno uporabo.
General Information
Relations
Overview
EN ISO 8362-2:2024 - "Injection containers and accessories - Part 2: Closures for injection vials" specifies shape, dimensions, materials, performance requirements and labelling for closures for injection vials (elastomeric vial stoppers) used with glass vials covered by ISO 8362‑1 and ISO 8362‑4. The standard applies to single‑use elastomeric closures (excluding dimensional requirements for barrier‑coated closures) and emphasizes the role of primary packaging in maintaining medicinal potency, purity, stability and safety.
Key topics and technical requirements
- Scope & classification
- Covers closures for parenteral vials; closures are intended for single use.
- Two types: Type A (without no‑pop/blow‑back) and Type B (with no‑pop/blow‑back feature).
- Shape and dimensions
- Detailed dimensional specifications and drawings (figure/table) define key diameters, heights and flange features.
- Dimensional tolerances follow ISO 3302 series; 2024 edition updates include a changed tolerance for a specified height (h) to ±0.25 mm.
- Material and manufacturing
- Elastomeric materials suitable for parenteral use; manufacturing subject to cGMP principles.
- Performance requirements
- Physical tests: hardness (Shore), penetrability, fragmentation, self‑sealing, aqueous solution tightness, and resistance to ageing.
- Chemical, biological and particulate contamination requirements (referenced test methods in ISO 8871 series).
- Labelling and designation
- Requirements for marking/identification to ensure correct use with corresponding vial types.
- Exclusions
- Dimensional requirements do not apply to barrier‑coated closures.
Applications and users
This standard is essential for:
- Pharmaceutical primary packaging designers and closure manufacturers
- Vial and syringe assembly suppliers
- Quality assurance, regulatory and compliance teams in pharma and biotech
- Test laboratories conducting physical, chemical and biological validation of closures
- Procurement and specification engineers selecting vial closures for parenteral products
Practical uses include designing compatible container‑closure systems, specifying acceptance criteria for incoming components, and validating closure performance to protect sterile injectable products.
Related standards
- ISO 8362‑1 (injection vials made of glass tubing)
- ISO 8362‑4 (injection vials made of moulded glass)
- ISO 8871 series (elastomeric parts - extractables/biological/functional tests)
- ISO 48‑4 (rubber hardness - Shore)
- ISO 3302‑1 / ISO 3302‑2 (rubber tolerances)
- ISO 15378 / GMP guidance (cGMP for primary packaging)
Keywords: EN ISO 8362-2:2024, closures for injection vials, elastomeric closures, vial stoppers, primary packaging, parenteral packaging, cGMP, vial closure dimensions, no‑pop blow‑back.
Frequently Asked Questions
EN ISO 8362-2:2024 is a standard published by the European Committee for Standardization (CEN). Its full title is "Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2024)". This standard covers: This document specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this document are intended for single use only. NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.
This document specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this document are intended for single use only. NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.
EN ISO 8362-2:2024 is classified under the following ICS (International Classification for Standards) categories: 11.040.20 - Transfusion, infusion and injection equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 8362-2:2024 has the following relationships with other standards: It is inter standard links to EN ISO 8362-2:2015/A1:2022, EN ISO 8362-2:2015. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase EN ISO 8362-2:2024 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2024
Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 2. del: Zapirala
za viale (ISO 8362-2:2024)
Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-
2:2024)
Injektionsbehältnisse und Zubehör - Teil 2: Stopfen für Injektionsflaschen (ISO 8362-
2:2024)
Récipients et accessoires pour produits injectables - Partie 2 : Bouchons pour flacons
(ISO 8362-2:2024)
Ta slovenski standard je istoveten z: EN ISO 8362-2:2024
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
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2024
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 8362-2:2015
English Version
Injection containers and accessories - Part 2: Closures for
injection vials (ISO 8362-2:2024)
Récipients et accessoires pour produits injectables - Injektionsbehältnisse und Zubehör - Teil 2: Stopfen für
Partie 2: Bouchons pour flacons (ISO 8362-2:2024) Injektionsflaschen (ISO 8362-2:2024)
This European Standard was approved by CEN on 21 December 2023.
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, 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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8362-2:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 8362-2:2024) 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 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 October 2024, and conflicting national standards shall
be withdrawn at the latest by October 2024.
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 8362-2:2015.
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 8362-2:2024 has been approved by CEN as EN ISO 8362-2:2024 without any
modification.
International
Standard
ISO 8362-2
Fourth edition
Injection containers and
2024-03
accessories —
Part 2:
Closures for injection vials
Récipients et accessoires pour produits injectables —
Partie 2: Bouchons pour flacons
Reference number
ISO 8362-2:2024(en) © ISO 2024
ISO 8362-2:2024(en)
© ISO 2024
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 8362-2:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Shape and dimensions . 2
6 Designation . 4
7 Material. 4
8 Performance requirements . . 4
8.1 General .4
8.2 Physical requirements .5
8.2.1 Hardness .5
8.2.2 Penetrability . . .5
8.2.3 Fragmentation .5
8.2.4 Self-sealing and aqueous solution tightness test .5
8.2.5 Aqueous solution tightness .5
8.2.6 Resistance to ageing .5
8.3 Chemical requirements . .5
8.4 Biological requirements .5
8.5 Particulate contamination requirements .5
9 Labelling . 5
Bibliography . 6
iii
ISO 8362-2:2024(en)
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.
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...