SIST EN ISO 8871-5:2014
(Main)Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2005)
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2005)
EN ISO 8871 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.
Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung - Teil 5: Funktionelle Anforderungen und Prüfung (ISO 8871-5:2005)
Dieser Teil von ISO 8871 legt Anforderungen und Prüfverfahren hinsichtlich funktioneller Merkmale von Verschlüssen aus Elastomeren fest, die für Injektionsflaschen verwendet und mit einer Injektionskanüle durchstochen werden.
ANMERKUNG Funktionelle Prüfungen unter Verwendung von Dornen sind in ISO 8536-2 und ISO 8536-6 festgelegt.
Éléments en élastomère pour administration parentérale et dispositifs à usage pharmaceutique - Partie 5: Exigences fonctionnelles et essais (ISO 8871-5:2005)
Deli iz elastomera za parenteralne farmacevtske oblike - 5. del: Funkcionalne zahteve in preskušanje (ISO 8871-5:2005)
Standard EN ISO 8871 določa zahteve in preskusne metode za funkcionalne parametre zapiral iz elastomera, ki se uporabljajo skupaj z vialami, ko jih predre injekcijska igla.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8871-5:2014
01-oktober-2014
Deli iz elastomera za parenteralne farmacevtske oblike - 5. del: Funkcionalne
zahteve in preskušanje (ISO 8871-5:2005)
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5:
Functional requirements and testing (ISO 8871-5:2005)
Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung -
Teil 5: Funktionelle Anforderungen und Prüfung (ISO 8871-5:2005)
Éléments en élastomère pour administration parentérale et dispositifs à usage
pharmaceutique - Partie 5: Exigences fonctionnelles et essais (ISO 8871-5:2005)
Ta slovenski standard je istoveten z: EN ISO 8871-5:2014
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8871-5:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8871-5:2014
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SIST EN ISO 8871-5:2014
EUROPEAN STANDARD
EN ISO 8871-5
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2014
ICS 11.040.20
English Version
Elastomeric parts for parenterals and for devices for
pharmaceutical use - Part 5: Functional requirements and testing
(ISO 8871-5:2005)
Éléments en élastomère pour administration parentérale et Elastomere Teile für Parenteralia und für Geräte zur
dispositifs à usage pharmaceutique - Partie 5: Exigences pharmazeutischen Verwendung - Teil 5: Funktionelle
fonctionnelles et essais (ISO 8871-5:2005) Anforderungen und Prüfung (ISO 8871-5:2005)
This European Standard was approved by CEN on 24 July 2014.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8871-5:2014 E
worldwide for CEN national Members.
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SIST EN ISO 8871-5:2014
EN ISO 8871-5:2014 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 8871-5:2014
EN ISO 8871-5:2014 (E)
Foreword
The text of ISO 8871-5:2005 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion
and injection, and blood processing equipment for medical and pharmaceutical use” of the International
Organization for Standardization (ISO) and has been taken over as EN ISO 8871-5:2014 by 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 January 2015, and conflicting national standards shall be withdrawn at
the latest by January 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 8871-5:2005 has been approved by CEN as EN ISO 8871-5:2014 without any modification.
3
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SIST EN ISO 8871-5:2014
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SIST EN ISO 8871-5:2014
INTERNATIONAL ISO
STANDARD 8871-5
First edition
2005-08-15
Elastomeric parts for parenterals and for
devices for pharmaceutical use —
Part 5:
Functional requirements and testing
Éléments en élastomère pour administration parentérale et dispositifs à
usage pharmaceutique —
Partie 5: Exigences fonctionnelles et essais
Reference number
ISO 8871-5:2005(E)
©
ISO 2005
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SIST EN ISO 8871-5:2014
ISO 8871-5:2005(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2005
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2005 – All rights reserved
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SIST EN ISO 8871-5:2014
ISO 8871-5:2005(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope .1
2 Normative references .1
3 Terms and definitions .1
4 Requirements.2
5 Preparation of elastomeric closures for testing.2
Annex A (normative) Test for penetrability .4
Annex B (normative) Test for fragmentation.5
Annex C (normative) Test for self-sealing and container closure seal integrity test .7
Annex D (normative) Test for container closure seal integrity .9
Bibliography .10
© ISO 2005 – All rights reserved iii
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SIST EN ISO 8871-5:2014
ISO 8871-5:2005(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 8871-5 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment
for medical and pharmaceutical use.
This first edition of ISO 8871-5, together with ISO 8871-1, ISO 8871-2, ISO 8871-3 and ISO 8871-4, cancels
and replaces ISO 8871:1990 and its Amendment 1:1995, which have 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 2005 – All rights reserved
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SIST EN ISO 8871-5:2014
ISO 8871-5:2005(E)
Introduction
Elastomeric or rubber closures for pharmaceutical use are used in combination with vials and many times in
conjunction with piercing devices. There are three functional parameters which are important to the piercing
process. These are: penetrability, fragmentation and self-sealing. The three functional tests described in this
part of ISO 8871 can be used as a reference method for testing elastomeric closures that are pierced using
injection needles made from metal. In addition, the container/closure seal integrity test can be used to verify
the effectiveness of the sealing of a specific closure/vial combination.
© ISO 2005 – All rights reserved v
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SIST EN ISO 8871-5:2014
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SIST EN ISO 8871-5:2014
INTERNATIONAL STANDARD ISO 8871-5:2005(E)
Elastomeric parts for parenterals and for devices for
pharmaceutical use —
Part 5:
Functional requirements and testing
1 Scope
This part of ISO 8871 specifies requirements and test methods for functional parameters of elastomeric
closures used in combination with vials and when pierced by an injection needle.
NOTE Functional testing with spikes is specified in ISO 8536-2 and in ISO 8536-6.
2 Normative references
The following referenced documents are indispensable for the application 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 7864, Sterile hypodermic needles for single use
ISO 8362-1, Injection containers and accessories — Part 1: Injection vials made of glass tubing
ISO 8362-3, Injection containers and accessories — Part 3: Aluminium caps for injection vials
ISO 8362-4, Injection containers and accessories — Part 4: Injection vials made of moulded glass
ISO 8362-6, Injection containers for injectables and accessories — Part 6: Caps made of aluminium-plastics
combinations for injection vials
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
penetrabil
...
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Deli iz elastomera za parenteralne farmacevtske oblike - 5. del: Funkcionalne zahteve in preskušanje (ISO 8871-5:2005)Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung - Teil 5: Funktionelle Anforderungen und Prüfung (ISO 8871-5:2005)Éléments en élastomère pour administration parentérale et dispositifs à usage pharmaceutique - Partie 5: Exigences fonctionnelles et essais (ISO 8871-5:2005)Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2005)11.040.20Transfuzijska, infuzijska in injekcijska opremaTransfusion, infusion and injection equipmentICS:Ta slovenski standard je istoveten z:FprEN ISO 8871-5kSIST FprEN ISO 8871-5:2014en01-april-2014kSIST FprEN ISO 8871-5:2014SLOVENSKI
STANDARD
kSIST FprEN ISO 8871-5:2014
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
FINAL DRAFT
FprEN ISO 8871-5
January 2014 ICS 11.040.20 English Version
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2005)
Éléments en élastomère pour administration parentérale et dispositifs à usage pharmaceutique - Partie 5: Exigences fonctionnelles et essais (ISO 8871-5:2005)
Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung - Teil 5: Funktionelle Anforderungen und Prüfung (ISO 8871-5:2005) This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee CEN/TC 205.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. FprEN ISO 8871-5:2014 EkSIST FprEN ISO 8871-5:2014
FprEN ISO 8871-5:2014 (E) 2 Contents Page Foreword .3
kSIST FprEN ISO 8871-5:2014
FprEN ISO 8871-5:2014 (E) 3 Foreword The text of ISO 8871-5:2005 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use” of the International Organization for Standardization (ISO) and has been taken over as FprEN ISO 8871-5:2014 by Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN. This document is currently submitted to the Unique Acceptance Procedure. Endorsement notice The text of ISO 8871-5:2005 has been approved by CEN as FprEN ISO 8871-5:2014 without any modification. kSIST FprEN ISO 8871-5:2014
kSIST FprEN ISO 8871-5:2014
Reference numberISO 8871-5:2005(E)© ISO 2005
INTERNATIONAL STANDARD ISO8871-5First edition2005-08-15Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing Éléments en élastomère pour administration parentérale et dispositifs à usage pharmaceutique —
Partie 5: Exigences fonctionnelles et essais
kSIST FprEN ISO 8871-5:2014
ISO 8871-5:2005(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
©
ISO 2005 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56 • CH-1211 Geneva 20 Tel.
+ 41 22 749 01 11 Fax
+ 41 22 749 09 47 E-mail
copyright@iso.org Web
www.iso.org Published in Switzerland
ii © ISO 2005 – All rights reserved
kSIST FprEN ISO 8871-5:2014
ISO 8871-5:2005(E) © ISO 2005 – All rights reserved iiiContents Page Foreword.iv Introduction.v 1 Scope.1 2 Normative references.1 3 Terms and definitions.1 4 Requirements.2 5 Preparation of elastomeric closures for testing.2 Annex A (normative)
Test for penetrability.4 Annex B (normative)
Test for fragmentation.5 Annex C (normative)
Test for self-sealing and container closure seal integrity test.7 Annex D (normative)
Test for container closure seal integrity.9 Bibliography.10
kSIST FprEN ISO 8871-5:2014
ISO 8871-5:2005(E) iv © ISO 2005 – All rights reserved 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 8871-5 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. This first edition of ISO 8871-5, together with ISO 8871-1, ISO 8871-2, ISO 8871-3 and ISO 8871-4, cancels and replaces ISO 8871:1990 and its Amendment 1:1995, which have 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
kSIST FprEN ISO 8871-5:2014
ISO 8871-5:2005(E) © ISO 2005 – All rights reserved vIntroduction Elastomeric or rubber closures for pharmaceutical use are used in combination with vials and many times in conjunction with piercing devices. There are three functional parameters which are important to the piercing process. These are: penetrability, fragmentation and self-sealing. The three functional tests described in this part of ISO 8871 can be used as a reference method for testing elastomeric closures that are pierced using injection needles made from metal. In addition, the container/closure seal integrity test can be used to verify the effectiveness of the sealing of a specific closure/vial combination. kSIST FprEN ISO 8871-5:2014
kSIST FprEN ISO 8871-5:2014
INTERNATIONAL STANDARD ISO 8871-5:2005(E) © ISO 2005 – All rights reserved 1Elastomeric parts for parenterals and for devices for pharmaceutical use —
Part 5: Functional requirements and testing 1 Scope This part of ISO 8871 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.
NOTE Functional testing with spikes is specified in ISO 8536-2 and in ISO 8536-6. 2 Normative references The following referenced documents are indispensable for the application 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 7864, Sterile hypodermic needles for single use ISO 8362-1, Injection containers and accessories — Part 1: Injection vials made of glass tubing
ISO 8362-3, Injection containers and accessories — Part 3: Aluminium caps for injection vials ISO 8362-4, Injection containers and accessories — Part 4: Injection vials made of moulded glass ISO 8362-6, Injection containers for injectables and accessories — Part 6: Caps made of aluminium-plastics combinations for injection vials 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 penetrability force required for piercing an elastomeric closure 3.2 fragmentation
measure of the number of elastomeric particles which are generated by the piercing process 3.3 self-sealing
measure of the resealing efficiency of elastomeric closures following penetration and withdrawal of a needle
kSIST FprEN ISO 8871-5:2014
ISO 8
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