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)

ISO 8871-5:2016 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

• Status: Published
• Publication Date: 22-Nov-2016
• Withdrawal Date: 30-May-2017
• 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: 23-Nov-2016
• Completion Date: 23-Nov-2016
• Ref Project: SIST EN ISO 8871-5:2017 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016)

Relations

• Replaces: 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)
• Effective Date: 30-Nov-2016

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.
Endorsem
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