EN ISO 8872:2022

Aluminium caps and aluminium/plastic caps for infusion bottles and injection vials - General requirements and test methods (ISO 8872:2022)

This document specifies general requirements and test methods for aluminium caps and aluminium/plastic caps intended for use on infusion bottles and/or injection vials.

Aluminium- und Aluminium/Kunststoff-Bördelkappen für Infusions- und Injektionsflaschen - Allgemeine Anforderungen und Prüfverfahren (ISO 8872:2022)

Diese Internationale Norm legt allgemeine Anforderungen und Prüfverfahren für Aluminium- und Aluminium/Kunststoff-Bördelkappen für Infusions- und Injektionsflaschen fest.

Capsules en aluminium et capsules en aluminium/plastique pour flacons de perfusion et d'injection - Exigences générales et méthodes d'essai (ISO 8872:2022)

Le présent document spécifie les exigences générales et les méthodes d’essai relatives aux capsules en aluminium et aux capsules en aluminium/plastique destinées à être utilisées sur des flacons de perfusion et/ou d’injection.

Aluminijeve in aluminijeve/plastične zaporke za infuzijske in injekcijske steklenice - Splošne zahteve in preskusne metode (ISO 8872:2022)

Ta dokument določa splošne zahteve in preskusne metode za aluminijeve in aluminijeve/plastične zaporke, namenjene za uporabo na infuzijskih in/ali injekcijskih steklenicah.

General Information

• Status: Published
• Publication Date: 22-Nov-2022
• 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: 23-Nov-2022
• Completion Date: 23-Nov-2022
• Ref Project: SIST EN ISO 8872:2023 - Aluminium caps and aluminium/plastic caps for infusion bottles and injection vials - General requirements and test methods (ISO 8872:2022)

Relations

• Replaces: EN ISO 8872:2003 - Aluminium caps for transfusion, infusion and injection bottles - General requirements and test methods (ISO 8872:2003)
• Effective Date: 30-Nov-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2023
Nadomešča:
SIST EN ISO 8872:2003
Aluminijeve in aluminijeve/plastične zaporke za infuzijske in injekcijske steklenice
- Splošne zahteve in preskusne metode (ISO 8872:2022)
Aluminium caps and aluminium/plastic caps for infusion bottles and injection vials -
General requirements and test methods (ISO 8872:2022)
Aluminium- und Aluminium/Kunststoff-Bördelkappen für Infusions- und Injektionsflaschen
- Allgemeine Anforderungen und Prüfverfahren (ISO 8872:2022)
Capsules en aluminium et capsules en aluminium/plastique pour flacons de perfusion et
d'injection - Exigences générales et méthodes d'essai (ISO 8872:2022)
Ta slovenski standard je istoveten z: EN ISO 8872:2022
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
77.150.10 Aluminijski izdelki Aluminium products
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 8872
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2022
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 8872:2003
English Version
Aluminium caps and aluminium/plastic caps for infusion
bottles and injection vials - General requirements and test
methods (ISO 8872:2022)
Capsules en aluminium et capsules en Aluminium- und Aluminium/Kunststoff-Bördelkappen
aluminium/plastique pour flacons de perfusion et für Infusions- und Injektionsflaschen - Allgemeine
d'injection - Exigences générales et méthodes d'essai Anforderungen und Prüfverfahren (ISO 8872:2022)
(ISO 8872:2022)
This European Standard was approved by CEN on 20 March 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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8872:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 8872:2022) 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 May 2023, and conflicting national standards shall be
withdrawn at the latest by May 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 8872:2003.
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 8872:2022 has been approved by CEN as EN ISO 8872:2022 without any modification.

INTERNATIONAL ISO
STANDARD 8872
Third edition
2022-11
Aluminium caps and aluminium/
plastic caps for infusion bottles
and injection vials — General
requirements and test methods
Capsules en aluminium et capsules en aluminium/plastique pour
flacons de perfusion et d'injection — Exigences générales et méthodes
d'essai
Reference number
ISO 8872:2022(E)
ISO 8872:2022(E)
© ISO 2022
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 8872:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 General . 2
4.2 Aluminium component . 2
4.2.1 Mechanical characteristics . 2
4.2.2 Chemical composition . . 2
4.2.3 Dimensions . 3
4.2.4 Contamination . 3
4.2.5 Earing . 3
4.2.6 Other defects . 3
4.3 Plastic component . 3
4.3.1 Mechanical characteristics . 3
4.3.2 Chemical composition . 3
4.3.3 Dimensions . 3
4.3.4 Contamination . 3
4.3.5 Other defects . 3
4.4 Functional requirements of aluminium and aluminium-plastic caps . 4
4.4.1 Opening and tear-off forces for aluminium caps . 4
4.4.2 Joining of aluminium and plastic component . 4
4.4.3 Opening and tear-off forces for aluminium/plastic caps . 4
4.4.4 Mechanical requirements after sterilization . 4
5 Test methods . 4
5.1 General . 4
5.2 Mechanical characteristics . 5
5.3 Chemical composition . 5
5.4 Dimensions . 5
5.5 Earing. 5
5.6 Opening and tear-off forces of aluminium and aluminium/ plastic caps . 5
5.7 Test methods after sterilization . 6
5.7.1 Stability of coating on aluminium . 6
5.7.2 Test method for premature opening and deformation . . 6
6 Packaging. 6
7 Marking . . 6
Annex A (informative) Aluminium and aluminium plastic caps – Type drawings .7
Annex B (normative) Opening and tear-off forces . 8
Bibliography .13
iii
ISO 8872:2022(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
...