EN ISO 8871-1:2004

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates (ISO 8871-1:2003)

ISO 8871-1:2003 defines procedures for classifying elastomeric parts for primary packs and medical devices used in direct contact with preparations for parenteral use, including both aqueous preparations and dry preparations which have to be dissolved before use.
It specifies a series of comparative test methods for chemical evaluation by the determination of extractables in aqueous autoclavates and describes the various fields of application for elastomeric parts. Dimensions and functional characteristics are specified in the relevant International Standards. Required properties as specified in this part of ISO 8871 are regarded as minimum requirements.
Elastomeric parts for empty syringes for single use are excluded from the scope of this part of ISO 8871 as they are not in contact with the injected preparation for a significant length of time.
Compatibility studies with the intended preparation have to be performed before the approval for final use can be given; however, this part of ISO 8871 does not specify procedures for carrying out compatibility studies.

Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung - Teil 1: Extrahierbare Substanzen in wässrigen Autoklavaten (ISO 8871-1:2003)

1.1   Dieser Teil von ISO 8871 legt Verfahren zur Einteilung von Elastomerteilen für Primärverpackungen und Medizinprodukte fest, die in direktem Kontakt mit wässrigen Zubereitungen zur parenteralen Anwendung (einschließlich Trockenpräparaten, die vor Gebrauch aufgelöst werden müssen) stehen, fest.
Sie legt eine Reihe vergleichender Prüfverfahren zur chemischen Bewertung (siehe Abschnitt 4) fest und beschreibt die vielfältigen Anwendungsgebiete für Elastomerteile. Maße und funktionelle Eigenschaften sind in den entsprechenden Internationalen Normen festgelegt. Die in diesem Teil von ISO 8871 festgelegten geforderten Eigenschaften sind als Mindestanforderungen zu verstehen.
1.2   Dieser Teil von ISO 8871 gilt für die in Abschnitt 3 aufgeführten Kategorien von Elastomerteilen; spezifische Anforderungen sind jedoch in den entsprechenden Internationalen Normen festgelegt, die die in Abschnitt 3 aufgeführten Gegenstände oder Geräte behandeln.
Elastomerteile für leere Einmalspritzen sind vom Anwendungsbereich dieses Teils von ISO 8871 ausgeschlossen, da sie nur kurzzeitig mit dem Injektionspräparat in Kontakt sind.
1.3   Bevor die endgültige Zulassung zur Anwendung gegeben werden kann, sind Verträglichkeitsuntersuchungen mit dem vorgesehenen Präparat durchzuführen; dieser Teil von ISO 8871 legt jedoch keine Verfahren zur Durchführung von Verträglichkeitsuntersuchungen fest.

Eléments en élastomère pour administration parentérale et dispositifs à usage pharmaceutique - Partie 1: Substances extractibles par autoclavage en milieu aqueux (ISO 8871-1:2003)

L'ISO 8871-1:2003 définit des modes opératoires permettant de classer les éléments en élastomère constituant les emballages primaires et les dispositifs médicaux qui entrent directement en contact avec les préparations à usage parentéral, y compris les préparations aqueuses et les préparations sèches qui doivent être dissoutes avant utilisation.
Elle spécifie une série de méthodes d'essai comparatives pour l'évaluation chimique par la détermination des substances extractibles par autoclavage en milieu aqueux et décrit les divers champs d'application des éléments en élastomère. Les dimensions et les caractéristiques fonctionnelles sont spécifiées dans les Normes internationales appropriées. Les propriétés requises spécifiées dans l'ISO 8871-1:2003 sont considérées comme des exigences minimales.
Les éléments en élastomère pour seringues vides non réutilisables sont exclus du domaine d'application de l'ISO 8871-1:2003, car ils n'entrent pas en contact avec la préparation injectée pendant une période de temps significative.
Des études de compatibilité avec les préparations prévues doivent être entreprises avant de pouvoir approuver ces éléments pour leur emploi final; toutefois, l'ISO 8871-1:2003 ne spécifie pas les procédures à suivre pour effectuer des études de compatibilité.

Deli iz elastomera za parenteralne farmacevtske oblike - 1. del: Izločki v vodnih avtoklavih (ISO 8871-1:2003)

General Information

• Status: Published
• Publication Date: 31-Aug-2004
• 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: 01-Sep-2004
• Completion Date: 01-Sep-2004
• Ref Project: SIST EN ISO 8871-1:2005 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates (ISO 8871-1:2003)

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

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2005
'HOLL]HODVWRPHUD]DSDUHQWHUDOQHIDUPDFHYWVNHREOLNHGHO,]ORþNLYYRGQLK
DYWRNODYLK,62
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1:
Extractables in aqueous autoclavates (ISO 8871-1:2003)
Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung -
Teil 1: Extrahierbare Substanzen in wässrigen Autoklavaten (ISO 8871-1:2003)
Eléments en élastomere pour administration parentérale et dispositifs a usage
pharmaceutique - Partie 1: Substances extractibles par autoclavage en milieu aqueux
(ISO 8871-1:2003)
Ta slovenski standard je istoveten z: EN ISO 8871-1:2004
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.

EUROPEAN STANDARD
EN ISO 8871-1
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 1: Extractables in aqueous
autoclavates (ISO 8871-1:2003)
Eléments en élastomère pour administration parentérale et
dispositifs à usage pharmaceutique - Partie 1: Substances
extractibles par autoclavage en milieu aqueux (ISO 8871-
1:2003)
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 8871-1:2004: E
worldwide for CEN national Members.

Foreword
The text of ISO 8871-1:2003 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-
1:2004 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 8871-1:2004 has been approved by CEN as EN ISO 8871-1:2004 without any
modifications.
NOTE Normative references to International Standards are listed in annex ZA (normative).

Annex ZA
(normative)
Normative references to international publications
with their relevant European publications

This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).

NOTE Where an International Publication has been modified by common modifications, indicated
by (mod.), the relevant EN/HD applies.

Publication Year Title EN Year

ISO 8362-2 1988 Injection containers for injectables EN 28362-2 1993
and accessories - Part 2: Closures
for injection vials
INTERNATIONAL ISO
STANDARD 8871-1
First edition
2003-10-01
Elastomeric parts for parenterals and for
devices for pharmaceutical use —
Part 1:
Extractables in aqueous autoclavates
Éléments en élastomère pour administration parentérale et dispositifs à
usage pharmaceutique —
Partie 1: Substances extractibles par autoclavage en milieu aqueux

Reference number
ISO 8871-1:2003(E)
©
ISO 2003
ISO 8871-1:2003(E)
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ii © ISO 2003 — All rights reserved

ISO 8871-1:2003(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Classification. 2
4 Requirements . 2
5 Sampling . 2
6 Apparatus and reagents. 3
7 Preparation of test solutions . 4
Annex A (normative) Appearance of solution . 5
Annex B (normative) Acidity or alkalinity . 9
Annex C (normative) Absorbance . 10
Annex D (normative) Reducing substances. 11
Annex E (normative) Extractable heavy metals . 12
Annex F (normative) Extractable zinc . 14
Annex G (normative) Extractable ammonia. 15
Annex H (normative) Residue on evaporation . 16
Annex I (normative) Volatile sulfides .17
Annex J (informative) Conductivity . 18
Bibliography . 19

ISO 8871-1:2003(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 8871-1 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment
for medical and pharmaceutical use.
Together with the other parts (see below), this part of ISO 8871 cancels and replaces ISO 8871:1990, which
has been technically revised.
ISO 8871 consists of the following parts, under the general title Elastomeric parts for parenterals and for
devices for pharmaceutical use:
 Part 1: Extractables in aqueous autoclavates
 Part 2: Identification and characterization
 Part 3: Determination of released-particle count
 Part 4: Biological requirements and test methods
 Part 5: Functional requirements and testing
iv © ISO 2003 — All rights reserved

ISO 8871-1:2003(E)
Introduction
The elastomeric parts specified in the various parts of this International Standard are produced from a material
which is usually called “rubber”. However, rubber is not a unique entity, since the composition of rubber
materials may 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 may have a significant effect on the overall properties. The effectiveness, purity, stability and
safe handling of a drug preparation may be affected adversely during manufacture, storage and administration
if the rubber part used has not been properly selected and validated (approved).
INTERNATIONAL STANDARD ISO 8871-1:2003(E)

Elastomeric parts for parenterals and for devices for
pharmaceutical use —
Part 1:
Extractables in aqueous autoclavates
1 Scope
1.1 This part of ISO 8871 defines procedures for classifying elastomeric parts for primary packs and
medical devices used in direct contact with preparations for parenteral use, including both aqueous
preparations and dry preparations which have to be dissolved before use.
It specifies a series of comparative test methods for chemical evaluation by the determination of extractables
in aqueous autoclavates (see Clause 4) and describes the various fields of application for elastomeric parts.
Dimensions and functional characteristics are specified in the relevant International Standards. Required
properties as specified in this part of ISO 8871 are regarded as minimum requirements.
1.2 This part of ISO 8871 is applicable for the categories of elastomeric parts given in Clause 3; specific
requirements, however, are laid down in the relevant International Standards dealing with the items or devices
listed in Clause 3.
Elastomeric parts for
...