SIST EN ISO 8872:2023
(Main)Aluminium caps and aluminium/plastic caps for infusion bottles and injection vials - General requirements and test methods (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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8872:2023
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
SIST EN ISO 8872:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8872:2023
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SIST EN ISO 8872:2023
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.
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SIST EN ISO 8872:2023
EN ISO 8872:2022 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 8872:2023
EN ISO 8872:2022 (E)
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.
3
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SIST EN ISO 8872:2023
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SIST EN ISO 8872:2023
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 2022
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SIST EN ISO 8872:2023
ISO 8872:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© 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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO 2022 – All rights reserved
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SIST EN ISO 8872:2023
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 2022 – All rights reserved
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SIST EN ISO 8872:2023
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 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 third edition cancels and replaces the second edition (ISO 8872:2003) and ISO 10985:2009, which
have been technically revised.
The main changes are as follows:
— integration of ISO 10985;
— addition of new terms;
— addition of a new Annex A, "Aluminium and aluminium plastic caps - Type drawings";
— addition of a new Annex B, "Opening and tear-off forces".
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 2022 – All rights reserved
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SIST EN ISO 8872:2023
ISO 8872:2022(E)
Introduction
The primary materials from which containers, including their elastomeric closures, are made must be
suitable for the storage of such products until the products are administered. However, in this document,
aluminium caps and aluminium/plastic caps are not considered as primary packaging materials that
will come into direct contact with pharmaceutical preparations. Aluminium and aluminium/plastic
caps can be delivered to customers as non-sterile products or as sterile products.
v
© ISO 2022 – All rights reserved
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SIST EN ISO 8872:2023
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SIST EN ISO 8872:2023
INTERNATIONAL STANDARD ISO 8872:2022(E)
Aluminium caps and aluminium/plastic caps for infusion
bottles an
...
SLOVENSKI STANDARD
oSIST prEN ISO 8872:2022
01-januar-2022
Aluminijeve in aluminijeve/plastične zaporke za infuzijske in injekcijske steklenice
- Splošne zahteve in preskusne metode (ISO/DIS 8872:2021)
Aluminium caps and aluminium/plastic caps for infusion bottles and injection vials -
General requirements and test methods (ISO/DIS 8872:2021)
Aluminium- und Aluminium/Kunststoff-Bördelkappen für Infusions- und Injektionsflaschen
- Allgemeine Anforderungen und Prüfverfahren (ISO/DIS 8872:2021)
Capsules en aluminium et capsules en aluminium/plastique pour flacons de perfusion et
d'injection - Exigences générales et méthodes d'essai (ISO/DIS 8872:2021)
Ta slovenski standard je istoveten z: prEN ISO 8872
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
77.150.10 Aluminijski izdelki Aluminium products
oSIST prEN ISO 8872:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 8872:2022
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oSIST prEN ISO 8872:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 8872
ISO/TC 76 Secretariat: DIN
Voting begins on: Voting terminates on:
2021-11-18 2022-02-10
Aluminium caps and aluminium/plastic caps for infusion
bottles and injection vials — General requirements and
test methods
ICS: 11.040.20
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 8872:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2021
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oSIST prEN ISO 8872:2022
ISO/DIS 8872:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
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 2021 – All rights reserved
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oSIST prEN ISO 8872:2022
ISO/DIS 8872:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 Aluminium component . 2
4.1.1 Mechanical characteristics . 2
4.1.2 Chemical composition . . 2
4.1.3 Dimensions . 2
4.1.4 Contamination . 3
4.1.5 Earing . 3
4.1.6 Other defects . 3
4.2 Plastic component . 3
4.2.1 Mechanical characteristics . 3
4.2.2 Chemical composition . . 3
4.2.3 Dimensions . 3
4.2.4 Contamination . 3
4.2.5 Other defects . 3
4.3 Functional requirements of aluminium and aluminium-plastic caps . 3
4.3.1 Opening and tear-off forces for aluminium caps . 3
4.3.2 Joining of aluminium and plastic component . 4
4.3.3 Opening and tear-off forces for aluminium/plastic caps . 4
4.3.4 Mechanical requirements after sterilization . 4
5 Test methods . 4
5.1 General . 4
5.2 Mechanical characteristics . 4
5.3 Chemical composition . 4
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 . 5
5.7.1 Stability of coating on aluminium . 5
5.7.2 Test method for premature opening and deformation . . 5
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 2021 – All rights reserved
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oSIST prEN ISO 8872:2022
ISO/DIS 8872:2021(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.
This third edition cancels and replaces the second edition (ISO 8872:2003), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— integration of ISO 10985 into ISO 8872;
— conversion to the present ISO standard format.
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 2021 – All rights reserved
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oSIST prEN ISO 8872:2022
ISO/DIS 8872:2021(E)
Introduction
This International Standard specifies requirements for aluminium caps and for aluminium/plastic caps
for bottles and vials in the field of infusion and injection. The primary materials from which containers,
including their elastomeric closures, are made have to be suitable for the storage of such products
until the products are administered. However, in this International Standard, aluminium caps and
aluminium/plastic caps are not considered as primary packaging materials that will come into direct
contact with pharmaceutical preparations. Aluminium and aluminium/plastic caps can be delivered to
customers as non-sterile products or as sterile products.
v
© ISO 2021 – All rights reserved
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oSIST prEN ISO 8872:2022
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oSIST prEN ISO 8872:2022
DRAFT INTERNATIONAL STANDARD ISO/DIS 8872:2021(E)
Aluminium caps and aluminium/plastic caps for infusion
bottles and injection vials — General requirements and
test methods
1 Scope
This International Standard specifies general requirements and test methods for aluminium caps and
aluminium/plastic caps intended for use on infusion bottles and/or injection vials.
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 6892-1, Metallic materials — Tensile testing — Part 1: Method of test at room temperature
ISO 7500-1, Metallic materials — Calibration and verification of static uniaxial testing machines — Part 1:
Tension/compression testing machines — Calibration and verification of the force-measuring system
ISO 8362-3, Injection containers and accessories — Part 3: Aluminium caps for injection vials
ISO 8362-6, Injection containers and accessories — Part 6: Caps made of aluminium-plastics combinations
for injection vials
ISO 8362-7, Injection containers and accessories — Part 7: Injection caps made of aluminium-plastics
combinations without overlapping plastics part
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
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
coating
surface lacquer or polymer layer on the aluminium part of the cap
Note 1 to entry: The coating allows for better processing and product differentiation
3.2
crimping
the act of fixating the aluminium or aluminium/plasti
...
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