EN ISO 8871-4:2006

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006)

ISO 8871-4:2006 specifies biological requirements for elastomeric parts for parenterals and for devices for pharmaceutical use. It also specifies the test methods, i.e. it offers the extraction procedures for elastomeric parts, and it makes reference to relevant biological test instructions in Pharmacopoeias and standards.

Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung - Teil 4: Biologische Anforderungen und Prüfverfahren (ISO 8871-4:2006)

Dieser Teil von ISO 8871 legt biologische Anforderungen für elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung fest. Er legt auch Prüfverfahren fest, in dem er Verfahren für die Extraktion von elastomeren Teilen enthält und auf entsprechende Anweisungen für biologische Prüfungen in Arzneibüchern und Normen Bezug nimmt.

Éléments en élastomère pour administration parentérale et dispositifs à usage pharmaceutique - Partie 4: Exigences biologiques et méthodes d'essais (ISO 8871-4:2006)

Deli iz elastomera za parenteralne farmacevtske oblike - 4. del: Biološke zahteve in preskusne metode (ISO 8871-4:2005)

General Information

• Status: Published
• Publication Date: 14-Jun-2006
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 15-Jun-2006
• Completion Date: 15-Jun-2006
• Ref Project: SIST EN ISO 8871-4:2006 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006)

Relations

• Replaces: EN ISO 8871:1997/A1:1999 - Elastomeric parts for aqueous parenteral preparations (ISO 8871:1997/AM1:1999)
• Effective Date: 15-Aug-2009
• Replaces: EN ISO 8871:1997 - Elastomeric parts for aqueous parenteral preparations (ISO 8871:1990)
• Effective Date: 15-Aug-2009

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2006
Deli iz elastomera za parenteralne farmacevtske oblike - 4. del: Biološke zahteve in
preskusne metode (ISO 8871-4:2005)
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4:
Biological requirements and test methods (ISO 8871-4:2006)
Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung -
Teil 4: Biologische Anforderungen und Prüfverfahren (ISO 8871-4:2006)
Éléments en élastomere pour administration parentérale et dispositifs a usage
pharmaceutique - Partie 4: Exigences biologiques et méthodes d'essais (ISO 8871-
4:2006)
Ta slovenski standard je istoveten z: EN ISO 8871-4:2006
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.

EUROPEAN STANDARD
EN ISO 8871-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2006
ICS 11.040.20 Supersedes EN ISO 8871:1997
English Version
Elastomeric parts for parenterals and for devices for
pharmaceutical use - Part 4: Biological requirements and test
methods (ISO 8871-4:2006)
Éléments en élastomère pour administration parentérale et Elastomere Teile für Parenteralia und für Geräte zur
dispositifs à usage pharmaceutique - Partie 4: Exigences pharmazeutischen Verwendung - Teil 4: Biologische
biologiques et méthodes d'essais (ISO 8871-4:2006) Anforderungen und Prüfverfahren (ISO 8871-4:2006)
This European Standard was approved by CEN on 5 June 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8871-4:2006: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 8871-4:2006) has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection equipment for medical and pharmaceutical use" in
collaboration with CMC.
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 December 2006, and conflicting national
standards shall be withdrawn at the latest by December 2006.

This document supersedes EN ISO 8871:1997.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

Endorsement notice
The text of ISO 8871-4:2006 has been approved by CEN as EN ISO 8871-4:2006 without any
modifications.
INTERNATIONAL ISO
STANDARD 8871-4
First edition
2006-06-15
Elastomeric parts for parenterals and for
devices for pharmaceutical use —
Part 4:
Biological requirements and test methods
Éléments en élastomère pour administration parentérale et dispositifs à
usage pharmaceutique —
Partie 4: Exigences biologiques et méthodes d'essai

Reference number
ISO 8871-4:2006(E)
©
ISO 2006
ISO 8871-4:2006(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.

©  ISO 2006
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. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2006 – All rights reserved

ISO 8871-4:2006(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.
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 8871-4 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment
for medical and pharmaceutical use.
This first edition, together with parts 1, 2, 3 and 5, cancels and replaces ISO 8871:1990 and
ISO 8871:1990/Amd.1:1995, 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
ISO 8871-4:2006(E)
Introduction
The pharmaceutical industry requires, to an increasing extent, concrete details from the rubber manufacturer
about the biological status of rubber closures as far as elastomeric closures are used as primary packaging
materials in direct contact with the medicinal products. This request has been taken into account by preparing
Annexes A to D of this part of ISO 8871.
Tests presented in this part of ISO 8871 can be taken into account as a guideline if the question of biological
safety arises in context with primary packaging materials for pharmaceutical products. The use of certain tests
of Annex A to Annex D in case of special applications of the packaging material should be agreed upon
between users and manufacturers.

iv © ISO 2006 – All rights reserved

INTERNATIONAL STANDARD ISO 8871-4:2006(E)

Elastomeric parts for parenterals and for devices
for pharmaceutical use —
Part 4:
Biological requirements and test methods
1 Scope
This part of ISO 8871 specifies biological requirements for elastomeric parts for parenterals and for devices
for pharmaceutical use. It also specifies the test methods, i.
...