EN ISO 8871-2:2020
(Main)Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2020)
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2020)
This document specifies identification and characterization procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices.
The physical and chemical test procedures specified in this document permit the determination of the typical characteristics of elastomeric parts including coatings and surface treatments and can serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. Depending upon the type of elastomer and its application, an appropriate set of tests is selected.
Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung - Teil 2: Identifizierung und Charakterisierung (ISO 8871-2:2020)
Dieses Dokument legt Verfahren zur Identifikation und Charakterisierung bei elastomeren Teilen einschließlich beschichteter Stopfen fest, die für Medikamentenbehälter und Medizinprodukte verwendet werden.
Die durch dieses Dokument zur Verfügung gestellten physikalischen und chemischen Prüfverfahren ermöglichen die Bestimmung der typischen Eigenschaften von elastomeren Teilen, einschließlich Beschichtungen und Oberflächenbehandlungen, und können als Grundlage für Vereinbarungen zwischen Hersteller und Anwender hinsichtlich der gleich bleibenden Eigenschaften des Produkts bei nachfolgenden Lieferungen dienen. Abhängig von der Elastomerart und ihrer Anwendung wird eine angemessene Reihe von Prüfungen ausgewählt.
Éléments en élastomère pour administration parentérale et dispositifs à usage pharmaceutique - Partie 2: dentification et caractérisation (ISO 8871-2:2020)
Le présent document spécifie des modes opératoires d'identification et de caractérisation applicables aux éléments en élastomère, notamment les bouchons revêtus, utilisés pour les articles de conditionnement des médicaments et les dispositifs médicaux.
Les modes opératoires d'essai physique et chimique présentés dans le présent document permettent de déterminer les caractéristiques types des éléments en élastomère, y compris les revêtements et les traitements de surface, 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 d'élastomère et de l'application.
Deli iz elastomera za parenteralne farmacevtske oblike - 2. del: Identifikacija in opredelitev (ISO 8871-2:2020)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2020
Nadomešča:
SIST EN ISO 8871-2:2005
SIST EN ISO 8871-2:2005/A1:2014
Deli iz elastomera za parenteralne farmacevtske oblike - 2. del: Identifikacija in
opredelitev (ISO 8871-2:2020)
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2:
Identification and characterization (ISO 8871-2:2020)
Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung -
Identifizierung und Charakterisierung (ISO 8871-2:2020)
Éléments en élastomère pour administration parentérale et dispositifs à usage
pharmaceutique - Partie 2: dentification et caractérisation (ISO 8871-2:2020)
Ta slovenski standard je istoveten z: EN ISO 8871-2:2020
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.
EN ISO 8871-2
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2020
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 8871-2:2004
English Version
Elastomeric parts for parenterals and for devices for
pharmaceutical use - Part 2: Identification and
characterization (ISO 8871-2:2020)
Éléments en élastomère pour administration Elastomere Teile für Parenteralia und für Geräte zur
parentérale et dispositifs à usage pharmaceutique - pharmazeutischen Verwendung - Teil 2:
Partie 2: dentification et caractérisation (ISO 8871- Identifizierung und Charakterisierung (ISO 8871-
2:2020) 2:2020)
This European Standard was approved by CEN on 21 April 2020.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8871-2:2020 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 8871-2:2020) 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 December 2020, and conflicting national standards
shall be withdrawn at the latest by December 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 8871-2:2004.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 8871-2:2020 has been approved by CEN as EN ISO 8871-2:2020 without any
modification.
INTERNATIONAL ISO
STANDARD 8871-2
Second edition
2020-05
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 8871-2:2020(E)
©
ISO 2020
ISO 8871-2:2020(E)
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
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ii © ISO 2020 – All rights reserved
ISO 8871-2:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Tests . 2
4.1 General . 2
4.2 Hardness . 2
4.3 Density . 2
4.4 Ash . 3
4.5 Infrared spectrum . 3
4.5.1 Material . 3
4.5.2 Coating . 3
4.6 Compression set . . 3
4.7 Swelling . 3
4.8 Development of a fingerprint by gas chromatography . 3
4.9 Detection of volatile substances by gas chromatography . 4
4.10 Determination of residual moisture . 4
4.11 Determination of fingerprint by thermogravimetric analysis (TGA) . 4
4.12 Determination of extractables in aqueous autoclavates . 4
5 Preparation of samples for testing . 4
5.1 Treatment before testing . 4
5.2 Number of samples needed for the tests . 4
6 Reagents and materials . 5
Annex A (informative) Identification of elastomeric material by pyrolysis IR .6
Annex B (informative) Determination of compression set . 8
Annex C (informative) Swelling behaviour in oils .10
Annex D (informative) Development of a fingerprint by gas chromatography .12
Annex E (informative) Analysis of volatile components by headspace gas chromatography .14
Annex F (informative) Determination of residual moisture .16
Annex G (informative) Determination of a fingerprint by thermal gravimetry (TG) .17
Annex H (informative) Determination of the elastomer identity and verification of the
presence of a coating by surface infrared spectroscopy [attenuated total reflection
(ATR)] .20
Bibliography .23
ISO 8871-2:2020(E)
Foreword
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electrotechnical standardization.
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described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
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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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
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