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)
This document specifies requirements and test methods for functional parameters of closures used in combination with vials and when pierced by an injection needle.
NOTE Functional testing with spikes is specified in ISO 8536-2, ISO 8536-6, ISO 8362-1 and ISO 8362-4.
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)
Le présent document spécifie les exigences et les méthodes d’essai portant sur les propriétés fonctionnelles des fermetures utilisées avec des flacons et percées à l’aide d’une aiguille pour injection.
NOTE Les essais fonctionnels à l’aide de trocarts sont spécifiés dans l’ISO 8536-2, l’ISO 8536-6, l’ISO 8362-1 et l’ISO 8362-4.
Deli iz elastomera za parenteralne farmacevtske oblike - 5. del: Funkcionalne zahteve in preskušanje (ISO/FDIS 8871-5:2024)
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 8871-5:2024
01-junij-2024
Nadomešča:
SIST EN ISO 8871-5:2017
Deli iz elastomera za parenteralne farmacevtske oblike - 5. del: Funkcionalne
zahteve in preskušanje (ISO/DIS 8871-5:2024)
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5:
Functional requirements and testing (ISO/DIS 8871-5:2024)
Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung -
Teil 5: Funktionelle Anforderungen und Prüfung (ISO/DIS 8871-5:2024)
Éléments en élastomère pour administration parentérale et dispositifs à usage
pharmaceutique - Partie 5: Exigences fonctionnelles et essais (ISO/DIS 8871-5:2024)
Ta slovenski standard je istoveten z: prEN ISO 8871-5
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
oSIST prEN ISO 8871-5:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN ISO 8871-5:2024
oSIST prEN ISO 8871-5:2024
DRAFT
International
Standard
ISO/DIS 8871-5
ISO/TC 76
Elastomeric parts for parenterals
Secretariat: DIN
and for devices for pharmaceutical
Voting begins on:
use —
2024-04-22
Part 5:
Voting terminates on:
2024-07-15
Functional requirements and
testing
Éléments en élastomère pour administration parentérale et
dispositifs à usage pharmaceutique —
Partie 5: Exigences fonctionnelles et essais
ICS: 11.040.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
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BEING ACCEPTABLE FOR INDUSTRIAL,
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NATIONAL REGULATIONS.
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.
Reference number
ISO/DIS 8871-5:2024(en)
oSIST prEN ISO 8871-5:2024
DRAFT
ISO/DIS 8871-5:2024(en)
International
Standard
ISO/DIS 8871-5
ISO/TC 76
Elastomeric parts for parenterals and
Secretariat: DIN
for devices for pharmaceutical use —
Voting begins on:
Part 5:
Functional requirements and testing
Voting terminates on:
Éléments en élastomère pour administration parentérale et
dispositifs à usage pharmaceutique —
Partie 5: Exigences fonctionnelles et essais
ICS: 11.040.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
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BE CONSIDERED IN THE LIGHT OF THEIR
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POTENTIAL TO BECOME STANDARDS TO
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PROVIDE SUPPORTING DOCUMENTATION.
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Published in Switzerland Reference number
ISO/DIS 8871-5:2024(en)
ii
oSIST prEN ISO 8871-5:2024
ISO/DIS 8871-5:2024(en)
Contents Page
Foreword .iv
Introduction .v
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 and dye solution tightness .2
4.4 Dye solution tightness.2
5 Preparation of elastomeric closures for testing . 2
5.1 Sampling .2
5.2 Cleaning .2
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 and dye solution tightness . 7
Annex D (normative) Test for dye solution tightness . 9
Bibliography .11
iii
oSIST prEN ISO 8871-5:2024
ISO/DIS 8871-5:2024(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 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 on the meaning of ISO specific terms and expressions related to conformity assessment,
as well as information about ISO's adherence to the WTO principles in the Technical Barriers to Trade (TBT)
see the following URL: Foreword - Supplementary information
The committee responsible for this document is 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 (8871-5:2016), which has been technically revised.
The main changes are as follows:
— replaced "aqueous solution tightness" with "dye solution tightness",
— additional definition for fragmentation,
— additional information on the fragmentation test and new information on the fragment size,
— replaced "pore size of 0,5 µm" with "pore size of maximum 5,0 µm",
— added USP <788> and USP <1207> references.
A list of all parts in the ISO 8871 series can be found on the ISO website.
iv
oSIST prEN ISO 8871-5:2024
ISO/DIS 8871-5:2024(en)
Introduction
Elastomeric or rubber closures for pharmaceutical use are used in combination with vials and many
times in conjunction with piercing devices. There are three functional parameters which are important
to the piercing process. These are penetrability, fragmentation and self-sealing. The three functional tests
described in this part of ISO 8871 can be used as a reference method for testing elastomeric closures that
are pierced using injection needles made from metal. In addition, the dye solution tightness test can be used
to verify the effectiveness of the sealing of a specific closure/vial combination.
v
oSIST prEN ISO 8871-5:2024
oSIST prEN ISO 8871-5:2024
DRAFT International Standard ISO/DIS 8871-5:2024(en)
Elastomeric parts for parenterals and for devices for
pharmaceutical use —
Part 5:
Functional requirements and testing
1 Scope
This part of ISO 8871 specifies requirements and test methods for functional parameters of elastomeric
closures used in combination with vials and when pierced by an injection needle.
[1] [2]
NOTE Functional testing with spikes is specified in and in .
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 7864, Sterile hypodermic needles for single use
ISO 8362-1, Injection containers and accessories — Part 1: Injection vials made of glass tubing
ISO 8362-3, Injection containers and accessories — Part 3: Aluminium caps for injection vials
ISO 8362-4, Injection containers and accessories — Part 4: Injection vials made of moulded glass
ISO 8362-6, Injection containers and accessories — Part 6: Caps made of aluminium-plastics combinations for
injection vials
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
penetrability
force required for piercing an elastomeric closure
3.2
fragmentation
formation of elastomeric particles that are generated when the disc or other elastomeric components that
forms part of the primary container closure is pierced by a needle, spike or other access device for filling or
delivery
Note 1 to entry: Coring is one mechanism to generate fragments.
[SOURCE: 11608-3:2022, 3.4, modified: change "disc coring" to "coring".]
3.3
self-sealing
measure of the resealing efficiency of elastomeric closures following penetration and withdrawal of a needle
oSIST prEN ISO 8871-5:2024
ISO/DIS 8871-5:2024(en)
3.4
dye solution tightness
measure for the effective sealing of a specific elastomeric closure/vial combination
4 Requirements
4.1 Penetrability
When tested in accordance with Annex A, the force required for piercing shall not be greater than 10 N for
each closure.
4.2 Fragmentation
When tested in accordance with Annex B, the number of elastomeric fragments per 48 piercings shall not be
greater than 5. The test conditions and acceptance criteria (limits for minimum fragment size and allowable
number of fragments) may have to be adapted in certain circumstances and can be agreed between the
supplier and the customer. For example, use of spike/need
...
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