SIST EN ISO 8871-5:2025
(Main)Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2025)
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2025)
ISO 8871-5:2016 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.
NOTE Functional testing with spikes is specified in ISO 8536‑2 and in ISO 8536‑6.
Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung - Teil 5: Funktionelle Anforderungen und Prüfung (ISO 8871-5:2025)
Dieses Dokument legt Anforderungen und Prüfverfahren hinsichtlich funktioneller Merkmale von Verschlüssen fest, die für Injektionsflaschen verwendet und mit einer Injektionskanüle durchstochen werden.
ANMERKUNG Funktionelle Prüfungen unter Verwendung von Dornen sind in ISO 8536 2, ISO 8536 6, ISO 8362 1 und ISO 8362 4 festgelegt.
Éléments en élastomère pour administration parentérale et dispositifs à usage pharmaceutique - Partie 5: Exigences fonctionnelles et essais (ISO 8871-5:2025)
ISO 8871:2016 spécifie les exigences et les méthodes d'essai portant sur les propriétés fonctionnelles des fermetures en élastomère, utilisées avec des flacons et percées à l'aide d'une aiguille pour injection.
NOTE Les essais fonctionnels à l'aide d'un trocart sont spécifiés dans l'ISO 8536‑2 et dans l'ISO 8536‑6.
Deli iz elastomera za parenteralne farmacevtske oblike - 5. del: Funkcionalne zahteve in preskušanje (ISO 8871-5:2025)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2025
Nadomešča:
SIST EN ISO 8871-5:2017
Deli iz elastomera za parenteralne farmacevtske oblike - 5. del: Funkcionalne
zahteve in preskušanje (ISO 8871-5:2025)
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5:
Functional requirements and testing (ISO 8871-5:2025)
Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung -
Teil 5: Funktionelle Anforderungen und Prüfung (ISO 8871-5:2025)
Éléments en élastomère pour administration parentérale et dispositifs à usage
pharmaceutique - Partie 5: Exigences fonctionnelles et essais (ISO 8871-5:2025)
Ta slovenski standard je istoveten z: EN ISO 8871-5:2025
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 8871-5
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2025
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 8871-5:2016
English Version
Elastomeric parts for parenterals and for devices for
pharmaceutical use - Part 5: Functional requirements and
testing (ISO 8871-5:2025)
Éléments en élastomère pour administration Elastomere Teile für Parenteralia und für Geräte zur
parentérale et dispositifs à usage pharmaceutique - pharmazeutischen Verwendung - Teil 5: Funktionelle
Partie 5: Exigences fonctionnelles et essais (ISO 8871- Anforderungen und Prüfung (ISO 8871-5:2025)
5:2025)
This European Standard was approved by CEN on 22 March 2025.
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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8871-5:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 8871-5:2025) 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 Technical Committee CEN/TC 205 “Non-active medical devices” the
secretariat of which is held by DIN.
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 September 2025, and conflicting national standards
shall be withdrawn at the latest by September 2025.
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 8871-5:2016.
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 8871-5:2025 has been approved by CEN as EN ISO 8871-5:2025 without any
modification.
International
Standard
ISO 8871-5
Third edition
Elastomeric parts for parenterals and
2025-03
for devices for pharmaceutical use —
Part 5:
Functional requirements and testing
Éléments en élastomère pour administration parentérale et
dispositifs à usage pharmaceutique —
Partie 5: Exigences fonctionnelles et essais
Reference number
ISO 8871-5:2025(en) © ISO 2025
ISO 8871-5:2025(en)
© ISO 2025
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 8871-5:2025(en)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 Penetrability .2
4.2 Fragmentation .2
4.3 Self-sealing .2
4.4 Dye solution tightness.2
5 Preparation of closures for testing . 2
5.1 Sampling .2
5.2 Cleaning .3
5.3 Sterilization .3
Annex A (normative) Test for penetrability . 4
Annex B (normative) Test for fragmentation . 5
Annex C (normative) Test for self-sealing . 7
Annex D (normative) Test for dye solution tightness . 9
Bibliography .11
iii
ISO 8871-5:2025(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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/TC 205, Non-active medical devices, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 8871-5:2016), which has been technically
revised.
The main changes are as follows:
— "aqueous solution tightness" has been replaced with "dye solution tightness";
— definition for fragmentation has been clarified;
— definitions for "filling volume" and "nominal volume" have been added;
— information on the fragmentation test and new information on the fragment size have been added;
— "pore size of 0,5 µm" has been replaced with "pore size of maximum 5,0 µm" to be aligned with
ISO 11608-3;
— clarification on the fragments counting measurements has been added;
— “dye solution tightness” from the self-sealing test has been removed;
— “solution of methylene blue” has been replaced by “appropriate dye solution” and new information on the
dye solution;
— “methylene blue” has been replaced by “dye solution”;
— references to USP <788> and USP <1207> have been added.
A list of all parts in the ISO 8871 series can be found on the ISO website.
iv
ISO 8871-5:2025(en)
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.
v
----------------
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.