Aluminium caps for transfusion, infusion and injection bottles - General requirements and test methods (ISO 8872:2003)

ISO 8872:2003 specifies general requirements and test methods for aluminium caps for injection vials, and for infusion and transfusion bottles.

Aluminium-Bördelkappen für Transfusions-, Infusions- und Injektionsflaschen - Allgemeine Anforderungen und Prüfverfahren (ISO 8872:2003)

Diese Internationale Norm legt allgemeine Anforderungen und Prüfverfahren für Aluminium-Bördelkappen für Injektions-, Infusions- und Transfusionsflaschen fest.

Capsules en aluminium pour flacons de transfusion, perfusion et injection - Spécifications générales et méthodes d'essai (ISO 8872:2003)

L'ISO 8872:2003 spécifie les exigences générales et les méthodes d'essai relatives aux capsules en aluminium pour flacons de transfusion, perfusion et injection.

Aluminijeve zaporke za transfuzijske, infuzijske in injekcijske steklenice - Splošne zahteve in preskusne metode (ISO 8872:2003)

General Information

Status
Withdrawn
Publication Date
31-Aug-2003
Withdrawal Date
05-Jan-2023
Technical Committee
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
06-Jan-2023
Due Date
29-Jan-2023
Completion Date
06-Jan-2023

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Aluminijeve zaporke za transfuzijske, infuzijske in injekcijske steklenice - Splošne zahteve in preskusne metode (ISO 8872:2003)Aluminium-Bördelkappen für Transfusions-, Infusions- und Injektionsflaschen - Allgemeine Anforderungen und Prüfverfahren (ISO 8872:2003)Capsules en aluminium pour flacons de transfusion, perfusion et injection - Spécifications générales et méthodes d'essai (ISO 8872:2003)Aluminium caps for transfusion, infusion and injection bottles - General requirements and test methods (ISO 8872:2003)11.040.20Transfuzijska, infuzijska in injekcijska opremaTransfusion, infusion and injection equipmentICS:Ta slovenski standard je istoveten z:EN ISO 8872:2003SIST EN ISO 8872:2003en01-september-2003SIST EN ISO 8872:2003SLOVENSKI
STANDARDSIST EN 28872:20001DGRPHãþD



SIST EN ISO 8872:2003



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 8872March 2003ICS 11.040.20Supersedes EN 28872:1993English versionAluminium caps for transfusion, infusion and injection bottles -General requirements and test methods (ISO 8872:2003)Capsules en aluminium pour flacons de transfusion,perfusion et injection - Spécifications générales etméthodes d'essai (ISO 8872:2003)Aluminium-Bördelkappen für Transfusions-, Infusions- undInjektionsflaschen - Allgemeine Anforderungen undPrüfverfahren (ISO 8872:2003)This European Standard was approved by CEN on 11 March 2003.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the 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 translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and UnitedKingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2003 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 8872:2003 ESIST EN ISO 8872:2003



EN ISO 8872:2003 (E)2CORRECTED
2003-05-14ForewordThis document (EN ISO 8872:2003) has been prepared by Technical Committee ISO/TC 76"Transfusion, infusion and injection equipment for medical and pharmaceutical use" incollaboration with CMC.This European Standard shall be given the status of a national standard, either by publication ofan identical text or by endorsement, at the latest by September 2003, and conflicting nationalstandards shall be withdrawn at the latest by September 2003.This document supersedes EN ISO 28872:1993.According to the CEN/CENELEC Internal Regulations, the national standards organizations ofthe following countries are bound to implement this European Standard: Austria, Belgium, CzechRepublic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland andthe United Kingdom.Endorsement noticeThe text of ISO 8872:2003 has been approved by CEN as EN ISO 8872:2003 without anymodifications.NOTE
Normative references to International Standards are listed in Annex ZA (normative).SIST EN ISO 8872:2003



EN ISO 8872:2003 (E)3Annex ZA(normative)Normative references to international publicationswith their relevant European publicationsThis European Standard incorporates by dated or undated reference, provisions from otherpublications. These normative references are cited at the appropriate places in the text and thepublications are listed hereafter. For dated references, subsequent amendments to or revisions ofany of these publications apply to this European Standard only when incorporated in it byamendment or revision. For undated references the latest edition of the publication referred toapplies (including amendments).NOTE Where an International Publication has been modified by common modifications, indicatedby (mod.), the relevant EN/HD applies.PublicationYearTitleENYearISO 7500-11999Metallic materials - Verification of staticuniaxial testing
machines - Part 1:Tension/compression testing machinesEN ISO 7500-11999ISO 8362-32001Injection containers and accessories -Part 3: Aluminium caps for injectionvialsEN ISO 8362-32003ISO 8536-31999Infusion equipment for medical use -Part 3: Aluminium caps for infusionbottlesEN ISO 8536-31999SIST EN ISO 8872:2003



SIST EN ISO 8872:2003



Reference numberISO 8872:2003(E)© ISO 2003
INTERNATIONAL STANDARD ISO8872Second edition2003-03-15Aluminium caps for transfusion, infusion and injection bottles — General requirements and test methods Capsules en aluminium pour flacons de transfusion, perfusion et injection — Spécifications générales et méthodes d'essai
SIST EN ISO 8872:2003



ISO 8872:2003(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
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ISO 2003 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56 • CH-1211 Geneva 20 Tel.
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ii © ISO 2003 — All rights reserved
SIST EN ISO 8872:2003



ISO 8872:2003(E) © ISO 2003 — All rights reserved iii 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. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. 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. ISO 8872 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. This second edition cancels and replaces the first edition (ISO 8872:1988), which has been technically revised. SIST EN ISO 8872:2003



ISO 8872:2003(E) iv © ISO 2003 — All rights reserved Introduction This International Standard specifies requirements for aluminium caps for vials and bottles in the field of transfusion, 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 cap
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