SIST EN ISO 8871-5:2017
(Main)Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016)
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016)
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.
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 8871-5:2016)
Dieser Teil von ISO 8871 legt Anforderungen und Prüfverfahren hinsichtlich funktioneller Merkmale von Verschlüssen aus Elastomeren fest, die für Injektionsflaschen verwendet und mit einer Injektionskanüle durchstochen werden.
ANMERKUNG Funktionelle Prüfungen unter Verwendung von Dornen sind in ISO 8536-2 und ISO 8536-6 festgelegt.
Éléments en élastomère pour administration parentérale et dispositifs à usage pharmaceutique - Partie 5 : Exigences fonctionnelles et essais (ISO 8871-5:2016)
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 8871-5:2016)
Ta del standarda ISO 8871 določa zahteve in preskusne metode za funkcionalne parametre zapiral iz elastomera, ki se uporabljajo skupaj z vialami, ko jih predre injekcijska igla.
OPOMBA: Preskušanje delovanja s konicami je določeno v standardih ISO 8536-2 in ISO 8536-6.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8871-5:2017
01-februar-2017
1DGRPHãþD
SIST EN ISO 8871-5:2014
Deli iz elastomera za parenteralne farmacevtske oblike - 5. del: Funkcionalne
zahteve in preskušanje (ISO 8871-5:2016)
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5:
Functional requirements and testing (ISO 8871-5:2016)
Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung -
Teil 5: Funktionelle Anforderungen und Prüfung (ISO 8871-5:2016)
Éléments en élastomère pour administration parentérale et dispositifs à usage
pharmaceutique - Partie 5 : Exigences fonctionnelles et essais (ISO 8871-5:2016)
Ta slovenski standard je istoveten z: EN ISO 8871-5:2016
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8871-5:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8871-5:2017
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SIST EN ISO 8871-5:2017
EN ISO 8871-5
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2016
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 8871-5:2014
English Version
Elastomeric parts for parenterals and for devices for
pharmaceutical use - Part 5: Functional requirements and
testing (ISO 8871-5:2016)
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 8871-5:2016)
5:2016)
This European Standard was approved by CEN on 6 August 2016.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8871-5:2016 E
worldwide for CEN national Members.
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SIST EN ISO 8871-5:2017
EN ISO 8871-5:2016 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 8871-5:2017
EN ISO 8871-5:2016 (E)
European foreword
This document (EN ISO 8871-5:2016) 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 May 2017 and conflicting national standards shall be
withdrawn at the latest by May 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 8871-5:2014.
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, Former Yugoslav Republic of Macedonia, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,
Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 8871-5:2016 has been approved by CEN as EN ISO 8871-5:2016 without any
modification.
3
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SIST EN ISO 8871-5:2017
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SIST EN ISO 8871-5:2017
INTERNATIONAL ISO
STANDARD 8871-5
Second edition
2016-10-15
Elastomeric parts for parenterals and
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 8871-5:2016(E)
©
ISO 2016
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SIST EN ISO 8871-5:2017
ISO 8871-5:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
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ISO copyright office
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Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
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SIST EN ISO 8871-5:2017
ISO 8871-5:2016(E)
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 aqueous solution tightness . 2
4.4 Aqueous solution tightness . 2
5 Preparation of elastomeric closures for testing . 2
5.1 Sampling . 2
5.2 Cleaning . 2
5.3 Sterilization . 2
Annex A (normative) Test for penetrability . 3
Annex B (normative) Test for fragmentation . 4
Annex C (normative) Test for self-sealing and dye solution tightness . 6
Annex D (normative) Test for dye solution tightness. 8
Bibliography .10
© ISO 2016 – All rights reserved iii
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SIST EN ISO 8871-5:2017
ISO 8871-5:2016(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 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 second edition cancels and replaces the first edition (ISO 8871-5:2005), which has been technically
revised.
ISO 8871 consists of the following parts, under the general title Elastomeric parts for parenterals and for
devices for pharmaceutical use:
— Part 1: Extractables in aqueous autoclavates
— Part 2: Identification and characterization
— Part 3: Determination of released-particle count
— Part 4: Biological requirements and test methods
— Part 5: Functional requirements and testing
iv © ISO 2016 – All rights reserved
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SIST EN ISO 8871-5:2017
ISO 8871-5:2016(E)
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 aqueous solution
tightness test can be used to verify the effectiveness of the sealing of a specific closure/vial combination.
© ISO 2016 – All rights reserved v
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SIST EN ISO 8871-5:2017
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SIST EN ISO 8871-5:2017
INTERNATIONAL STANDARD ISO 8871-5:2016(E)
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 o
...
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