EN ISO 8871-5:2014

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2005)

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.

Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung - Teil 5: Funktionelle Anforderungen und Prüfung (ISO 8871-5:2005)

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 8871-5:2005)

Deli iz elastomera za parenteralne farmacevtske oblike - 5. del: Funkcionalne zahteve in preskušanje (ISO 8871-5:2005)

Standard EN ISO 8871 določa zahteve in preskusne metode za funkcionalne parametre zapiral iz elastomera, ki se uporabljajo skupaj z vialami, ko jih predre injekcijska igla.

General Information

• Status: Withdrawn
• Publication Date: 29-Jul-2014
• Withdrawal Date: 22-Nov-2016
• 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: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 23-Nov-2016
• Ref Project: SIST EN ISO 8871-5:2014 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2005)

Relations

• Replaced By: EN ISO 8871-5:2016 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016)
• Effective Date: 30-Nov-2016

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8871-5:2014
01-oktober-2014
Deli iz elastomera za parenteralne farmacevtske oblike - 5. del: Funkcionalne
zahteve in preskušanje (ISO 8871-5:2005)
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5:
Functional requirements and testing (ISO 8871-5:2005)
Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung -
Teil 5: Funktionelle Anforderungen und Prüfung (ISO 8871-5:2005)
Éléments en élastomère pour administration parentérale et dispositifs à usage
pharmaceutique - Partie 5: Exigences fonctionnelles et essais (ISO 8871-5:2005)
Ta slovenski standard je istoveten z: EN ISO 8871-5:2014
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8871-5:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8871-5:2014

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SIST EN ISO 8871-5:2014

EUROPEAN STANDARD
EN ISO 8871-5

NORME EUROPÉENNE

EUROPÄISCHE NORM
July 2014
ICS 11.040.20
English Version
Elastomeric parts for parenterals and for devices for
pharmaceutical use - Part 5: Functional requirements and testing
(ISO 8871-5:2005)
Éléments en élastomère pour administration parentérale et Elastomere Teile für Parenteralia und für Geräte zur
dispositifs à usage pharmaceutique - Partie 5: Exigences pharmazeutischen Verwendung - Teil 5: Funktionelle
fonctionnelles et essais (ISO 8871-5:2005) Anforderungen und Prüfung (ISO 8871-5:2005)
This European Standard was approved by CEN on 24 July 2014.

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
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8871-5:2014 E
worldwide for CEN national Members.

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SIST EN ISO 8871-5:2014
EN ISO 8871-5:2014 (E)
Contents Page
Foreword .3
2

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SIST EN ISO 8871-5:2014
EN ISO 8871-5:2014 (E)
Foreword
The text of ISO 8871-5:2005 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion
and injection, and blood processing equipment for medical and pharmaceutical use” of the International
Organization for Standardization (ISO) and has been taken over as EN ISO 8871-5:2014 by 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 January 2015, and conflicting national standards shall be withdrawn at
the latest by January 2015.
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.
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 8871-5:2005 has been
...