EN 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

• Status: Published
• Publication Date: 02-Jun-2020
• Withdrawal Date: 30-Dec-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: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 03-Jun-2020
• Completion Date: 03-Jun-2020
• Ref Project: SIST EN ISO 8871-2:2020 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2020)

Relations

• Replaces: 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: 10-Jun-2020
• Replaces: EN ISO 8871-2:2004 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2003)
• Effective Date: 10-Oct-2018

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
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: [phone]
Fax: [phone]
Email: [e-mail]
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 document was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection,
and blood processing equipment for medical and pharmaceutical use, in collaboration with the European
Committee for Standardization (CEN) Technical Committee CEN/TC 205, Non-active medical devices, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 8871-2:2003), which has been technically
revised. It also incorporates the Amendment ISO 8871-2:2003/Amd.1:2005. The main changes compared
to the previous edition are as follows:
— expansion of the scope to include coated stoppers;
— addition of terms and definitions;
— addition of H.6 on the interpretation of results for ATR.
A list of all parts in the ISO 8871 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved

ISO 8871-2:2020(E)
Introduction
The elastomeric parts specified in the ISO 8871 series are produced from rubber. However, rubber is not
a unique entity, since the composition of rubber materials can vary considerably. The base elastomer
and the type of vulcanization have a major influence on the principle characteristics of an individual
rubber material, as do additives such as fillers, softeners and pigments. These might have a significant
effect on the overall properties. Polymer coatings or films are often applied to either entire or partial
surface(s) of a rubber component to impart certain physical or chemical properties. The effectiveness,
purity, stability and safe handling of a drug preparation can be affected adversely during manufacture,
storage and administration if the rubber part used has not been properly selected and validated
(approved).
INTERNATIONAL STANDARD ISO 8871-2:2020(E)
Elastomeric parts for parenterals and for devices for
pharmaceutical use —
Part 2:
Identification and characterization
1 Scope
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 48-4, Rubber, vulcanized or thermoplastic — Determination of hardness — Part 4: Indentation
hardness by durometer method (Shore hardness)
ISO 247-1:2018, Rubber — Determination of ash — Part 1: Combustion method
ISO 2781:2018, Rubber, vulcanized or thermoplastic — Determination of density
ISO 8871-1, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables
in aqueous autoclavates
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
barrier coating
layer of a different polymer completely or partly covering the elastomeric part to reduce migration,
permeation and/or interactions of substances of rubber component to drug product and vice versa
Note 1 to entry: The coating can be applied by different techniques, such as spraying, tumbling or vapour-
depositing a liquid or vapour onto the rubber component or laminating a film onto the elastomeric surface during
the moulding process.
Note 2 to entry: The presence of the coating can be verified by using the test method described in Annex H.
ISO 8871-2:2020(E)
3.2
elastomer
base polymer that is converted into rubber by vulcanization
3.3
lubrication coating
layer of a different polymer completely or partly covering the elastomeric part to support functionality
in the final container closure system
Note 1 to entry: Certain lubrication coatings can also be used to eliminate the need for silicone oil in the container
closure system and/or enhancing other functionalities, such as gliding force, break loose force or removal force.
Note 2 to entry: The coating can be applied by different techniques, such as spraying, tumbling or vapour-
depositing a liquid or vapour onto the rubber component or laminating a film onto the elastomeric surface.
3.4
rubber
vulcanized material obtained by crosslinking of elastomer
[SOURCE: ISO 11999-1:2015 3.75, modified]
3.5
surface treatment
treatment of the surface of rubber by physical or chemical means to get desired properties
EXAMPLE Siliconization, chlorination.
Note 1 to entry: Surface treatments are applied to avoid sticking together and enhance machinability on
processing lines.
4 Tests
4.1 General
Rubber is a complex material and it is not generally definable. The only property which all elastomeric
materials have in common is a special type of resilience or elasticity. When a strip of rubber is stretched,
it will extend by up to many times its original length without breaking. On release of the stretching
force, it snaps back to its original size and shape virtually unaltered. Similarly, one can squeeze it, twist
it or distort it in any direction comparatively easily, and it will virtually spring back again to its original
shape unchanged.
Owing to its three-dimensional network, achieved by chemical cross-linking of the elastomer during
vulcanization, rubber is practically insoluble in solvents such as tetrahydrofuran, although considerable
reversible swelling may occur; this characteristic differentiates rubber from pseudo-elastic materials,
such as poly(vinyl chloride) and certain thermoplastic elastomers.
In view of the complexity of rubber, a set of tests is needed for reliable identification.
The manufacturer shall guarantee that all elastomeric parts of current supplies have been produced
from the same formulation and that they exhibit the same characteristics as the initially supplied
samples.
4.2 Hardness
Hardness shall be determined in accordance with ISO 48-4.
4.3 Density
Density shall be determined in accordance with the procedure described in ISO 2781:2018, Clause 4,
method A.
2 © ISO 2020 – All rights reserved

ISO 8871-2:2020(E)
4.4 Ash
The inorganic residue after combustion shall be determined as described in ISO 247-1:2018, 4.1,
method A.
4.5 Infrared spectrum
4.5.1 Material
One method to create a fingerprint of a rubber material is to record an infrared (IR) spectrum. The two
common methods for obtaining an IR spectrum of a rubber material are pyrolysis IR and surface IR/
ATR (attenuated total reflectance)-technique.
The pyrolysis IR can be obtained as described in Annex A. Alternatively, an aliquot of the pyrolysate can
be brought on an ATR crystal of an FTIR-spectrometer as described in Annex H. The surface IR/ATR can
be obtained as described in Annex H. The spectra should be compared with a spectrum obtained by the
same IR method on a reference sample of the material.
In practice, pyrolysis IR requires a time-consuming sample preparation. In addition, it needs the
cautious handling of hazardous vapours and oils.
In contrast to this, the surface IR/ATR offers the possibility to obtain a fingerprint from an elastomeric
part with minimum or no sample preparation.
4.5.2 Coating
The presence of a coating (barrier and lubrication coating) can be verified by comparing FTIR spectra
of the surface and of the core material of the product (see Annex H). For measuring the coating, the
samples do not need to be cut.
4.6 Compression set
The compression set indicates the degree of permanent deformation remaining after compression
at a constant deformation and defined temperature for a defined time. The compression set can be
determined in accordance with Annex B.
4.7 Swelling
Elastomeric materials are subject to varying degrees of swelling when exposed to organic solvents.
The degree of volume and/or mass increase is primarily influenced by the type of elastomer. Swelling
requires special care when the rubber components are in contact with emulsions or oily vehicles.
The relevant procedure is specified in Annex C.
4.8 Development of a fingerprint by gas chromatography
The elastomeric materials under examination are extracted in a solvent which does not dissolve but
might swell the rubber. The extract is injected into a gas chromatograph. The chromatogram obtained
exhibits a typical profile and can be used as a fingerprint for identification purposes. Furthermore,
GC-coupling techniques, for example gas chromatography – mass spectrometry (GC-MS), may provide
additional information about the composition of the extract.
The relevant procedure is specified in Annex D.
ISO 8871-2:2020(E)
4.9 Detection of volatile substances by gas chromatography
Elastomeric materials may release volatile substances. These may originate from one of the following
categories of material:
— oligomers or process aids present in the base polymer;
— stabilizers or antioxidants;
— softeners.
The relevant procedure is specified in Annex E.
4.10 Determination of residual moisture
While undergoing treatments which are typical in the pharmaceutical industry, elastomeric parts can
absorb moisture in considerable quantities. During storage of the pharmaceutical product, the trapped
moisture may be released and absorbed by the pharmaceutical product, thus reducing its effectiveness
(critical case: Iyophilized drugs). The nature of the absorption and desorption processes is affected by
the composition of the rubber, the type of treatment (e.g. steam autoclaving) and the efficiency of any
subsequent drying process.
The relevant procedure is specified in Annex F.
4.11 Determination of fingerprint by thermogravimetric analysis (TGA)
Elastomeric parts are composed of components which can be classified relative to their performance
under thermal treatment, as follows:
— base polymers;
— inorganic fillers;
— substances volatile at elevated temperatures;
— carbon black.
The relevant procedure is specified in Annex G.
4.12 Determination of extractables in aqueous autoclavates
Elastomeric materials may release substances of undetermined nature in water. For the general
assessment of the chemical cleanliness of closures ISO 8871-1 applies.
5 Preparation of samples for testing
5.1 Treatment before testing
The various test procedures may require different pretreatments, se
...