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
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
23-Nov-2022
Completion Date
23-Nov-2022

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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
Nort
...

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 .
...

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