EN ISO 8871-2:2004

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2003)

ISO 8871-2:2003 specifies evaluation procedures applicable to elastomeric parts used for drug containers and medical devices in order to guarantee the product identity between the samples evaluated in the (suitability test) acceptance process and the current supplies. The physical and chemical test procedures specified in this part of ISO 8871 permit the determination of the typical characteristics of rubber materials, and may serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. An appropriate set of tests is selected, depending upon the type of rubber and its application.
This part of ISO 8871 does not specify other requirements for rubber materials. These are laid down in the relevant product standards.

Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung - Teil 2: Identifizierung und Charakterisierung (ISO 8871-2:2003)

Dieser Teil von ISO 8871 legt Verfahren zur Anwendung bei elastomeren Teilen fest, die für Medikamentenbehälter und Medizinprodukte verwendet werden, um die Identität der laufenden Lieferungen des Produkts mit den im Zulassungsverfahren (Eignungsprüfung) bewerteten Proben sicherzustellen. Die durch diesen Teil von ISO 8871 zur Verfügung gestellten physikalischen und chemischen Prüfverfahren ermöglichen die Bestimmung der typischen Eigenschaften von Gummimaterialien und können als Grundlage für Vereinbarungen zwischen Hersteller und Anwender hinsichtlich der gleich bleibenden Eigenschaften des Produkts bei nachfolgenden Lieferungen dienen. Abhängig vom Typ des Gummis und seiner Anwendung ist eine geeignete Zusammenstellung von Prüfungen auszuwählen.
Dieser Teil von ISO 8871 legt keine Anforderungen an Gummimaterialien fest. Diese sind in den anwendbaren Produktnormen festgelegt.

Eléments en élastomère pour administration parentérale et dispositifs à usage pharmaceutique - Partie 2: Identification et caractérisation (ISO 8871-2:2003)

L'ISO 8871-2:2003 spécifie des modes opératoires d'évaluation applicables aux éléments en élastomère utilisés pour les articles de conditionnement des médicaments et les dispositifs médicaux afin de garantir que le produit livré est identique aux échantillons évalués lors du processus d'acceptation (de l'essai d'aptitude à l'emploi). Les modes opératoires d'essai des caractéristiques physiques et chimiques présentés dans l'ISO 8871-2:2003 permettent de déterminer les caractéristiques types des caoutchoucs et peuvent servir de base à des accords entre le fabricant et l'utilisateur en ce qui concerne la reproductibilité du produit lors des livraisons ultérieures. Un ensemble approprié d'essais est choisi en fonction du type de caoutchouc et de l'application.
L'ISO 8871-2:2003 ne spécifie pas les exigences ultérieures du caoutchouc; celles-ci sont données dans les normes appropriées du produit.

Deli iz elastomera za parenteralne farmacevtske oblike - 2. del: Identifikacija in opredelitev (ISO 8871-2:2003)

General Information

• Status: Withdrawn
• Publication Date: 31-Aug-2004
• Withdrawal Date: 02-Jun-2020
• 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: 03-Jun-2020
• Ref Project: SIST EN ISO 8871-2:2005 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2003)

Relations

• Replaces: EN ISO 8871:1997 - Elastomeric parts for aqueous parenteral preparations (ISO 8871:1990)
• Effective Date: 08-Jun-2022
• Replaces: EN ISO 8871:1997/A1:1999 - Elastomeric parts for aqueous parenteral preparations (ISO 8871:1997/AM1:1999)
• Effective Date: 08-Jun-2022
• Replaced By: EN ISO 8871-2:2020 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2020)
• Effective Date: 10-Oct-2018
• Amended By: EN ISO 8871-2:2004/A1:2014 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization - Amendment 1 (ISO 8871-2:2003/Amd 1:2005)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8871-2:2005
01-marec-2005
Deli iz elastomera za parenteralne farmacevtske oblike - 2. del: Identifikacija in
opredelitev (ISO 8871-2:2003)
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2:
Identification and characterization (ISO 8871-2:2003)
Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung -
Teil 2: Identifizierung und Charakterisierung (ISO 8871-2:2003)
Eléments en élastomere pour administration parentérale et dispositifs a usage
pharmaceutique - Partie 2: Identification et caractérisation (ISO 8871-2:2003)
Ta slovenski standard je istoveten z: EN ISO 8871-2:2004
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8871-2:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 8871-2:2005

---------------------- Page: 2 ----------------------

SIST EN ISO 8871-2:2005
EUROPEAN STANDARD
EN ISO 8871-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2004
ICS 11.040.20 Supersedes EN ISO 8871:1997
English version
Elastomeric parts for parenterals and for devices for
pharmaceutical use - Part 2: Identification and characterization
(ISO 8871-2:2003)
Eléments en élastomère pour administration parentérale et
dispositifs à usage pharmaceutique - Partie 2: Identification
et caractérisation (ISO 8871-2:2003)
This European Standard was approved by CEN on 15 July 2004.
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, 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
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8871-2:2004: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 8871-2:2005
EN ISO 8871-2:2004 (E)






Foreword


The text of ISO 8871-2:2003 has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection equipment for medical and pharmaceutical use" of the
International Organization for Standardization (ISO) and has been taken over as EN ISO 8871-
2:2004 by 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 March 2005, and conflicting national
standards shall be withdrawn at the latest by March 2005.

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, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.


Endorsement notice

The text of ISO 8871-2:2003 has been approved by CEN as EN ISO 8871-2:2004 without any
modifications.

2

---------------------- Page: 4 ----------------------

SIST EN ISO 8871-2:2005


INTERNATIONAL ISO
STANDARD 8871-2
First edition
2003-10-01


Elastomeric parts for parenterals and for
devices for pharmaceutical use —
Part 2:
Identification and characterization
Éléments en élastomère pour administration parentérale et dispositifs à
usage pharmaceutique —
Partie 2: Identification et caractérisation




Reference number
ISO 8871-2:2003(E)
©
ISO 2003

---------------------- Page: 5 ----------------------

SIST EN ISO 8871-2:2005
ISO 8871-2:2003(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
d
...