Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2020)

ISO 8871-2 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 - 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
Public Enquiry End Date
24-Apr-2019
Publication Date
16-Jun-2020
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
11-Jun-2020
Due Date
16-Aug-2020
Completion Date
17-Jun-2020

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SLOVENSKI STANDARD
SIST EN ISO 8871-2:2020
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
SIST EN ISO 8871-2:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8871-2:2020
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SIST EN ISO 8871-2:2020
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.
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SIST EN ISO 8871-2:2020
EN ISO 8871-2:2020 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 8871-2:2020
EN ISO 8871-2:2020 (E)
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.
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SIST EN ISO 8871-2:2020
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SIST EN ISO 8871-2:2020
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
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SIST EN ISO 8871-2:2020
ISO 8871-2:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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SIST EN ISO 8871-2:2020
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 2020 – All rights reserved iii
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SIST EN ISO 8871-2:2020
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
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SIST EN ISO 8871-2:2020
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).
© ISO 2020 – All rights reserved v
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SIST EN ISO 8871-2:2020
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SIST EN ISO 8871-2:2020
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 2020 – All rights reserved 1
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SIST EN ISO 8871-2:2020
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.
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SIST EN ISO 8871-2:2020
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.
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SIST EN ISO 8871-2:2020
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, see Annexes A to H.

It is generally assumed that samples of rubber parts will be provided in a clean state in accordance with

the state of the art. In order to avoid contamination, they shall be contained in a suitable packaging. Any

particular treatment or method of packaging to be carried out by the manufacturer shall be subject to

agreement between the manufacturer and the customer.
5.2 Number of samples needed for the tests

Due to the large number of tests in this document and their complexity, usually not all of the tests are

performed in each investigation. For this reason, the number of samples needed shall be agreed on

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SIST EN ISO 8871-2:2020
ISO 8871-2:2020(E)

between the manufacturer and the test laboratory. Each annex specifies the number of samples that are

needed to perform that specific test.
6 Reagents and materials

6.1 Use only reagents of recognized analytical grade, for example water Grade 1 or 2 of ISO 3696 or

any comparable water quality according to current USP and Ph Eur.
6.2 All glass equipment shall be made from borosilicate glass.
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SIST EN ISO 8871-2:2020
ISO 8871-2:2020(E)
Annex A
(informative)
Identification of elastomeric material by pyrolysis IR
A.1 General

When rubber parts are exposed to dry heat with restricted access to oxygen, the elastomeric matrix is

thermally disintegrated and the rubber is converted into polymer fragments which appear in the form

of vapour or oils of various viscosities.

These oily products are used to produce an IR spectrum which can serve to identify the original rubber

material.
A.2 Reagents and materials
A.2.1 Dry, filtered acetone, to clean the potassium bromide (KBr) discs.
A.2.2 Indicator paper.
A.2.3 Copper wire.
A.2.4 Acetone.
A.2.5 Trichloromethane.
A.2.6 Sodium sulfate, anhydrous.
A.3 Apparatus
−1 −1

A.3.1 IR spectrometer, to produce IR spectra in the range from 700 cm to 3 800 cm and from 0 %

to 100 % transmission.
A.3.2 KBr discs, including spacers and clamps.
A.3.3 Desiccator.
A.3.4 Bunsen burner.
A.3.5 Test tubes, for the pyrolysis process.
A.3.6 Soxhlet extraction apparatus (optional).
A.4 Sample preparation
Cut about 3 g of a rubber part into pieces of about 3 mm × 3 mm.
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SIST EN ISO 8871-2:2020
ISO 8871-2:2020(E)

Optionally, extract the rubber pieces thus produced with acetone in a Soxhlet extractor under reflux

for 8 h.
A.5 Pyrolysis

Place 0,2 g to 2 g of the rubber pieces in a test tube. Heat with a bunsen burner, carefully driving off

any water which may initially condense above the sample. Subsequently, with the test tube in a nearly

vertical position, expose the rubber pieces to the blue area of the flame. The pyrolysis products

condense as an oil in the cool zone of the test tube. During the pyrolysis, the pH of the vapour released

may be checked with wet indicator paper. An acidic reaction indicates the presence of halogen in the

rubber [parallel to this pH check, a Be
...

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