EN ISO 8536-2:2023

Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2023)

This document specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1.
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.

Infusionsgeräte zur medizinischen Verwendung - Teil 2: Stopfen für Infusionsflaschen (ISO 8536-2:2023)

Dieses Dokument legt die Form, die Maße, den Werkstoff, die Leistungsanforderungen und die Kennzeichnung von Stopfen für Infusionsflaschen nach ISO8536-1 fest.
Die Anforderungen an die Maße sind nicht anzuwenden für beschichtete Stopfen.
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.

Matériel de perfusion à usage médical - Partie 2: Bouchons pour flacons de perfusion (ISO 8536-2:2023)

Le présent document spécifie la forme, les dimensions, le matériau, les exigences de performance et l'étiquetage des bouchons pour flacons de perfusion spécifiés dans l'ISO 8536-1.
Les exigences dimensionnelles ne s'appliquent pas aux bouchons avec revêtement protecteur.
Les bouchons faisant l'objet du présent document sont à usage unique.
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.

Infuzijska oprema za uporabo v medicini - 2. del: Zapirala za infuzijske steklenice (ISO 8536-2:2023)

Ta dokument določa obliko, dimenzije, material, delovne zahteve in etiketiranje zapiral za infuzijske steklenice, kot je določeno v standard ISO 8536-1.
Zahteve glede dimenzij ne veljajo za zapirala s pregrado.
Zapirala, ki jih določa ta dokument, so namenjena le za enkratno uporabo.
OPOMBA:       Na jakost, čistost, stabilnost in varnost zdravila med proizvodnjo in skladiščenjem lahko močno vplivata tip in zmogljivost primarne embalaže.

General Information

• Status: Published
• Publication Date: 14-Feb-2023
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/SS S02 - Transfusion equipment
• Drafting Committee: CEN/SS S02 - Transfusion equipment
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 15-Feb-2023
• Completion Date: 15-Feb-2023
• Ref Project: SIST EN ISO 8536-2:2023 - Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2023)

Relations

• Replaces: EN ISO 8536-2:2010 - Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2010)
• Effective Date: 19-Jan-2023

Overview

EN ISO 8536-2:2023 - Infusion equipment for medical use - Part 2: Closures for infusion bottles - specifies the shape, dimensions, materials, performance requirements and labelling for elastomeric closures used on infusion glass bottles (as referenced in ISO 8536-1). The standard applies to single‑use closures (note: dimensional requirements do not apply to barrier‑coated closures) and replaces the 2010 edition, adding a 29 mm size to align with ISO 8536-1.

Key topics and technical requirements

• Shape & dimensions: Prescribed geometries for two typical closure designs (type A and B) with dimensional tolerances; flange conicity and allowable indentations are covered.
• Designation: Naming convention (e.g., Infusion closure ISO 8536-2 - 32 - A) to ensure clear identification and compatibility.
• Material & sterilization: Elastomeric formulations must meet performance requirements and withstand two autoclave cycles at (121 ± 2) °C for 30 min without functional impairment; suitability for other sterilization methods (e.g., irradiation) must be demonstrated.
• Performance tests (normative annexes):
  • Hardness (Shore)
  • Fragmentation (annex A) - limits on particulates released on piercing
  • Spike penetration force (annex B) - controlled piercing characteristics for access devices
  • Spike retention / sealability (annex C) - leakage and reseal performance after piercing
  • Resistance to ageing, chemical and biological requirements (including extractables and biocompatibility tests per referenced documents)
  • Closure piercing device specification (annex D) used for testing
• Labelling: Requirements to support traceability and correct use.
• Quality context: Recognizes that primary packaging affects potency, purity and stability; principles of cGMP apply to manufacturing.

Practical applications and users

Who uses EN ISO 8536-2:2023:

• Closure and elastomeric component manufacturers - to design and validate infusion bottle closures.
• Pharmaceutical and medical device manufacturers - to select compliant primary packaging for parenteral products.
• Quality, regulatory and procurement teams - to specify requirements in supplier contracts and technical files.
• Test laboratories and conformity assessors - to perform standardized performance and biological tests.

Practical benefits:

• Ensures mechanical compatibility with infusion bottles and predictable piercing behavior.
• Reduces fragmentation and contamination risk at point of access.
• Supports regulatory compliance, consistent supplier qualification and safe parenteral product packaging.

Related standards

• ISO 8536-1 (Infusion glass bottles)
• ISO 8536-3, ISO 8536-7 (caps and aluminium/plastic caps)
• ISO 8871 series (elastomeric parts - extractables/biological)
• ISO 15378 / GMP guidelines (cGMP for primary packaging)

Keywords: EN ISO 8536-2:2023, closures for infusion bottles, infusion equipment standard, elastomeric closures, spike penetration force, sealability, primary packaging, cGMP.

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2023
Nadomešča:
SIST EN ISO 8536-2:2010
Infuzijska oprema za uporabo v medicini - 2. del: Zapirala za infuzijske steklenice
(ISO 8536-2:2023)
Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-
2:2023)
Infusionsgeräte zur medizinischen Verwendung - Teil 2: Stopfen für Infusionsflaschen
(ISO 8536-2:2023)
Matériel de perfusion à usage médical - Partie 2: Bouchons pour flacons de perfusion
(ISO 8536-2:2023)
Ta slovenski standard je istoveten z: EN ISO 8536-2:2023
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 8536-2
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2023
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 8536-2:2010
English Version
Infusion equipment for medical use - Part 2: Closures for
infusion bottles (ISO 8536-2:2023)
Matériel de perfusion à usage médical - Partie 2: Infusionsgeräte zur medizinischen Verwendung - Teil
Bouchons pour flacons de perfusion (ISO 8536-2:2023) 2: Stopfen für Infusionsflaschen (ISO 8536-2:2023)
This European Standard was approved by CEN on 17 June 2022.

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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-2:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 8536-2:2023) 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 August 2023, and conflicting national standards shall
be withdrawn at the latest by August 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.
This document supersedes EN ISO 8536-2:2010.
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 8536-2:2023 has been approved by CEN as EN ISO 8536-2:2023 without any
modification.
INTERNATIONAL ISO
STANDARD 8536-2
Fourth edition
2023-01
Infusion equipment for medical use —
Part 2:
Closures for infusion bottles
Matériel de perfusion à usage médical —
Partie 2: Bouchons pour flacons de perfusion
Reference number
ISO 8536-2:2023(E)
ISO 8536-2:2023(E)
© ISO 2023
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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 8536-2:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Shape and dimensions .2
5 Designation . 3
6 Material. 3
7 Requirements . 3
7.1 General . 3
7.2 Physical requirements . 3
7.2.1 Hardness . 3
7.2.2 Fragmentation . 3
7.2.3 Spike penetration force . 3
7.2.4 Spike retention/sealability . 4
7.2.5 Resistance to ageing . 4
7.3 Chemical requirements . . 4
7.4 Biological requirements . 4
8 Labelling . 4
Annex A (normative) Determination of fragments . 5
Annex B (normative) Determination of spike penetration force . 7
Annex C (normative) Spike retention/sealability . 9
Annex D (normative) Closure piercing device .11
Bibliography .12
iii
ISO 8536-2:2023(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,
and blood processing equipment for medical and pharmaceutical use, in collaboration with the European
Committee for Standardization (CEN) Technical Committee CEN/SS S02, Transfusion equipment, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This fourth edition cancels and replaces the third edition (ISO 8536-2:2010), which has been technically
revised.
The main changes are as follows:
— removal of reference to ISO 7619-1,
— addition of 29 mm size closures to align with ISO 8536-1.
A list of all parts in the ISO 8536 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 8536-2:2023(E)
Introduction
Primary packaging components made of elastomeric materials are an integral part of medicinal products
and thus the principles of current Good Manufacturing Practice (cGMP) apply to the manufacturing of
these components.
Principles of cGMP are described in, e.g. ISO 15378 or GMP Guidelines as published by the European
Community and the United States of America.
v
INTERNATIONAL STANDARD ISO 8536-2:2023(E)
Infusion equipment for medical use —
Part 2:
Closures for infusion bottles
1 Scope
This document specifies the shape, dimensions, material, performance requirements and labelling of
closures for infusion bottles as specified in ISO 8536-1.
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 48-4, Rubber, vulcanized or thermoplastic — Determination of hardness — Part 4: Indentation
hardness by durometer method (Shore hardness)
ISO 3302-1, Rubber — Tolerances for products — Part 1: Dimensional tolerances
ISO 3302-2, Rubber — Tolerances for products — Part 2: Geometrical tolerances
ISO 8536-1, Infusion equipment for medical use — Part 1: Infusion glass bottles
ISO 8536-3, Infusion equipment for medical use — Part 3: Aluminium caps for infusion bottles
ISO 8536-7, Infusion equipment for medical use — Part 7: Caps made of aluminium-plastics combinations
for infusion bottles
ISO 8871-1, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables
in aqueous autoclavates
ISO 8871-4, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 4: Biological
requirements and t
...