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
SIST EN ISO 8871-4:2006
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
SIST EN ISO 8871-4:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8871-4:2006

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SIST EN ISO 8871-4:2006
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.

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SIST EN ISO 8871-4:2006

EN ISO 8871-4:2006 (E)





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.

2

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SIST EN ISO 8871-4:2006

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

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SIST EN ISO 8871-4:2006
ISO 8871-4:2006(E)
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