EN ISO 8871-2:2020

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
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
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
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
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
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
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).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see
www .iso .org/ iso/ foreword .html.
This doc
...