EN ISO 8871-3:2004

Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3: Determination of released-particle count (ISO 8871-3:2003)

Elastomeric closures may be superficially contaminated with visible and subvisible particles, and fragments can also be produced when the closure is pierced by a needle.
Such particles may be transferred to pharmaceutical preparations in contact with the elastomeric parts and affect the quality of such preparations.
ISO 8871-3:2003 specifies methods for the determination of the number of visible and subvisible particles, respectively, detached from elastomeric parts by rinsing.
It does not specify particle contamination limits. These will have to be agreed upon between manufacturer and user.

Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung - Teil 3: Bestimmung von herausgelösten Partikeln (ISO 8871-3:2003)

Elastomerstopfen können auf der Oberfläche mit visuell sichtbaren und unsichtbaren Partikeln kontaminiert sein.
Derartige Partikel können auf pharmazeutische Zubereitungen, die mit den Elastomerteilen in Kontakt kom-men, übertragen werden und die Qualität dieser Zubereitungen beeinträchtigen.
Das in diesem Teil der ISO 8871 beschriebene Verfahren ist für die Bestimmung visuell sichtbarer und unsicht-barer Partikel nach Abspülen von den Elastomerteilen geeignet.
Grenzwerte für die Kontamination von Elastomerteilen mit Partikeln sind in der Norm nicht festgelegt und müssen individuell zwischen Hersteller und Abnehmer vereinbart werden.

Éléments en élastomère pour administration parentérale et dispositifs à usage pharmaceutique - Partie 3: Dénombrement des particules libérées (ISO 8871-3:2003)

Les fermetures en élastomère peuvent être contaminées superficiellement par des particules visibles et des particules non visibles à l'oeil nu, des fragments pouvant également se produire lorsque la fermeture est percée à l'aide d'une aiguille.
Ces particules peuvent être transférées aux préparations pharmaceutiques en contact avec les éléments en élastomère et détériorer la qualité de ces préparations.
L'ISO 8871-3:2003 spécifie des méthodes de détermination du nombre de particules visibles et de particules non visibles à l'oeil nu, respectivement, séparées des éléments en élastomère par rinçage.
Elle ne spécifie pas de limites de contamination par les particules. Ces limites doivent faire l'objet d'un accord entre le fabricant et l'utilisateur.

Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3: Determination of released-particle count (ISO 8871-3:2003)

Zapirala iz elastomera so lahko površinsko kontaminirana z vidnimi in nevidnimi delci, prav tako se lahko delci ustvarijo, ko igla predre zapiralo.
Takšni delci se lahko prenesejo v farmacevtske pripravke v stiku z deli iz elastomera in lahko vplivajo na kakovost takšnih pripravkov.
Ta del standarda ISO 8871 določa metode za določanje števila vidnih in nevidnih delcev, ki odstopijo od delov iz elastomera pri izpiranju.
Ne določa mejnih vrednosti kontaminacije z delci. O teh se morata dogovoriti proizvajalec in uporabnik.

General Information

• Status: Published
• Publication Date: 25-May-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: 26-May-2004
• Completion Date: 26-May-2004
• Ref Project: SIST EN ISO 8871-3:2004 - Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3: Determination of released-particle count (ISO 8871-3:2003)

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
• Amended By: EN ISO 8871-3:2004/A1:2019 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count - Amendment 1 (ISO 8871-3:2003/Amd 1:2018)
• Effective Date: 04-Apr-2018

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2004
1DGRPHãþD
SIST EN ISO 8871:2000
SIST EN ISO 8871:2000/A1:2000
Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3:
Determination of released-particle count (ISO 8871-3:2003)
Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3:
Determination of released-particle count (ISO 8871-3:2003)
Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung -
Teil 3: Bestimmung von herausgelösten Partikeln (ISO 8871-3:2003)
Éléments en élastomere pour administration parentérale et dispositifs a usage
pharmaceutique - Partie 3: Dénombrement des particules libérées (ISO 8871-3:2003)
Ta slovenski standard je istoveten z: EN ISO 8871-3:2004
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 8871-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2004
ICS 11.040.20 Supersedes EN ISO 8871:1997
English version
Elastomeric parts for parenterals and for devices for
pharmaceuticals use - Part 3: Determination of released-particle
count (ISO 8871-3:2003)
Éléments en élastomère pour administration parentérale et Elastomere Teile für Parenteralia und für Geräte zur
dispositifs à usage pharmaceutique - Partie 3: pharmazeutischen Verwendung - Teil 3: Bestimmung von
Dénombrement des particules libérées (ISO 8871-3:2003) herausgelösten Partikeln (ISO 8871-3:2003)
This European Standard was approved by CEN on 1 April 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 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 Management Centre 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 8871-3:2004 E
worldwide for CEN national Members.

Foreword
The text of ISO 8871-3:2003 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-
3:2004 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 November 2004, and conflicting national
standards shall be withdrawn at the latest by November 2004.
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 8871-3:2003 has been approved by CEN as EN ISO 8871-3:2004 without any
modifications.
INTERNATIONAL ISO
STANDARD 8871-3
First edition
2003-08-01
Elastomeric parts for parenterals and for
devices for pharmaceutical use —
Part 3:
Determination of released-particle count
Éléments en élastomère pour administration parentérale et dispositifs à
usage pharmaceutique —
Partie 3: Dénombrement des particules libérées

Reference number
ISO 8871-3:2003(E)
©
ISO 2003
ISO 8871-3:2003(E)
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ii © ISO 2003 — All rights reserved

ISO 8871-3:2003(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Determination of visible-particle count . 1
4 Determination of subvisible-particle count. 3
Bibliography . 6

ISO 8871-3:2003(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 8871-3 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 8871-3:2003(E)
Introduction
When elastomeric closures are used as primary packaging materials in direct contact with pharmaceutical
preparations, the pharmaceutical industry requires, to an increasing e
...