SIST EN ISO 8536-2:2010
(Main)Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2010)
Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2010)
This part of ISO 8536 specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this part of ISO 8536 are intended for single use only.
Infusionsgeräte zur medizinischen Verwendung - Teil 2: Stopfen für Infusionsflaschen (ISO 8536-2:2010)
Dieser Teil von ISO 8536 legt die Form, die Maße, den Werkstoff, die Leistungsanforderungen und die
Kennzeichnung von Stopfen für Infusionsflaschen nach ISO 8536-1 fest.
Die Anforderungen an die Maße gelten nicht für beschichtete Stopfen.
Stopfen nach diesem Teil von ISO 8536 sind nur zur einmaligen Verwendung bestimmt.
ANMERKUNG Die Wirksamkeit, Reinheit, Beständigkeit und Sicherheit eines Arzneimittels während seiner Herstellung
und Lagerung können erheblich durch die Art und Ausführung des Primärpackmittels beeinträchtigt werden.
Matériel de perfusion à usage médical - Partie 2: Bouchons pour flacons de perfusion (ISO 8536-2:2010)
L'ISO 8536-2:2010 spécifie la forme, les dimensions, le matériau, les exigences de performance et l'étiquetage des bouchons pour flacons de perfusion spécifiés dans l'ISO 8536-1.
Les exigences dimensionnelles ne s'appliquent pas aux bouchons avec revêtement protecteur.
Les bouchons faisant l'objet de l'ISO 8536-2:2010 sont à usage unique.
Infuzijska oprema za uporabo v medicini - 2. del: Zapirala za infuzijske steklenice (ISO 8536-2:2010)
Ta del ISO 8536 določa obliko, mere, material, zahteve za delovanje in uporabo nalepk za zapirala za infuzijske steklenice, kot določa ISO 8536-1. Zahteve za mere ne veljajo za zapirala s pregrado. Zapirala, ki jih določa ta del ISO 8536, so namenjena le enkratni uporabi.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8536-2:2010
01-junij-2010
1DGRPHãþD
SIST EN ISO 8536-2:2003
SIST EN ISO 8536-2:2003/AC:2005
Infuzijska oprema za uporabo v medicini - 2. del: Zapirala za infuzijske steklenice
(ISO 8536-2:2010)
Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-
2:2010)
Infusionsgeräte zur medizinischen Verwendung - Teil 2: Stopfen für Infusionsflaschen
(ISO 8536-2:2010)
Matériel de perfusion à usage médical - Partie 2: Bouchons pour flacons de perfusion
(ISO 8536-2:2010)
Ta slovenski standard je istoveten z: EN ISO 8536-2:2010
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8536-2:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8536-2:2010
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SIST EN ISO 8536-2:2010
EUROPEAN STANDARD
EN ISO 8536-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2010
ICS 11.040.20 Supersedes EN ISO 8536-2:2002
English Version
Infusion equipment for medical use - Part 2: Closures for
infusion bottles (ISO 8536-2:2010)
Matériel de perfusion à usage médical - Partie 2: Bouchons Infusionsgeräte zur medizinischen Verwendung - Teil 2:
pour flacons de perfusion (ISO 8536-2:2010) Stopfen für Infusionsflaschen (ISO 8536-2:2010)
This European Standard was approved by CEN on 18 February 2010.
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 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 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-2:2010: E
worldwide for CEN national Members.
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SIST EN ISO 8536-2:2010
EN ISO 8536-2:2010 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 8536-2:2010
EN ISO 8536-2:2010 (E)
Foreword
This document (EN ISO 8536-2:2010) has been prepared by Technical Committee ISO/TC 76 "Transfusion,
infusion and injection equipment for medical and pharmaceutical use".
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 September 2010, and conflicting national standards shall be
withdrawn at the latest by September 2010.
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.
This document supersedes EN ISO 8536-2:2002.
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, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 8536-2:2010 has been approved by CEN as a EN ISO 8536-2:2010 without any modification.
3
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SIST EN ISO 8536-2:2010
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SIST EN ISO 8536-2:2010
INTERNATIONAL ISO
STANDARD 8536-2
Third edition
2010-03-15
Corrected version
2010-05-15
Infusion equipment for medical use —
Part 2:
Closures for infusion bottles
Matériel de perfusion à usage médical —
Partie 2: Bouchons pour flacons de perfusion
Reference number
ISO 8536-2:2010(E)
©
ISO 2010
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SIST EN ISO 8536-2:2010
ISO 8536-2:2010(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.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2010
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 2010 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 8536-2:2010
ISO 8536-2:2010(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Shape and dimensions .1
4 Designation .3
5 Material .3
6 Requirements.3
6.1 General .3
6.2 Physical requirements .3
6.3 Chemical requirements.4
6.4 Biological requirements.4
7 Labelling.4
Annex A (normative) Determination of fragments.5
Annex B (normative) Determination of spike penetration force .7
Annex C (normative) Spike retention/sealability .9
Annex D (normative) Closure piercing device.10
Bibliography.11
© ISO 2010 – All rights reserved iii
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SIST EN ISO 8536-2:2010
ISO 8536-2:2010(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 8536-2 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment
for medical and pharmaceutical use.
This third edition cancels and replaces the second edition (ISO 8536-2:2001) and ISO 8536:2001/Cor.1:2003
which have been technically revised in order to align this part of ISO 8536 with ISO 8871-1, ISO 8871-4 and
ISO 8871-5.
ISO 8536 consists of the following parts, under the general title Infusion equipment for medical use:
⎯ Part 1: Infusion glass bottles
⎯ Part 2: Closures for infusion bottles
⎯ Part 3: Aluminium caps for infusion bottles
⎯ Part 4: Infusion sets for single use, gravity feed
⎯ Part 5: Burette infusion sets for single use, gravity feed
⎯ Part 6: Freeze drying closures for infusion bottles
⎯ Part 7: Caps made of aluminium-plastics combinations for infusion bottles
⎯ Part 8: Infusion equipment for use with pressure infusion apparatus
⎯ Part 9: Fluid lines for use with pressure infusion equipment
⎯ Part 10: Accessories for fluid lines for use with pressure infusion equipment
⎯ Part 11: Infusion filters for use with pressure infusion equipment
⎯ Part 12: Check valves
This corrected version of ISO 8536-2:2010 incorporates the following correction:
⎯ Page 6, Note in A.3.7: “50 mm” has been replaced by “50 µm”.
iv © ISO 2010 – All rights reserved
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SIST EN ISO 8536-2:2010
ISO 8536-2:2010(E)
Introduction
The purpose of this part of ISO 8536 is to specify the shape and dimensions of and the requirements for
elastomeric closures intended for infusion bottles. In order to provide seal integrity of the container closure
systems the dimensions of the elastomeric closures have to be compatible with the dimensions of the infusion
bottles and the caps as specified in corresponding parts of ISO 8536.
Primary packaging components made of elastomeric materials are an integral part of medicinal products and
thus the principles of current Good Manufacturing Practice (cGMP) apply to the manufacturing of these
components.
Principles of cGMP are described in, e.g. ISO 15378 or GMP Guidelines as published by the European
Community and the United States of America.
© ISO 2010 – All rights reserved v
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SIST EN ISO 8536-2:2010
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SIST EN ISO 8536-2:2010
INTERNATIONAL STANDARD ISO 8536-2:2010(E)
Infusion equipment for medical use —
Part 2:
Closures for infusion bottles
1 Scope
This part of ISO 8536 specifies the shape, dimensions, material, performance requirements and labelling of
closures for infusion bottles as specified in ISO 8536-1.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this part of ISO 8536 are intended for single use only.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly
be affected by the nature and performance of the primary packaging.
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 48, Rubber, vulcanized or thermoplastic — Determination of hardness (hardness between 10 IRHD and
100 IRHD)
ISO 3302-1, Rubber — Tolerances for products — Part 1: Dimensional tolerances
ISO 3302-2, Rubber — Tolerances for products — Part 2: Geometrical tolerances
ISO 7619-1, Rubber, vulcanized or thermoplastic — Determination of indentation hardness — Part 1:
Durometer method (Shore hardness)
ISO 8536-1, Infusion equipment for medical use — Part 1: Infusion glass bottles
ISO 8536-3, Infusion equipment for medical use — Part 3: Aluminium caps for infusion bottles
ISO 8871-1, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables
in aqueous autoclavates
ISO 8871-4, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 4: Biological
requirements and test methods
3 Shape and dimensions
3.1 The shape and dimensions of closures shall be as shown in Figure 1 and as given in Table 1. Figure 1
illustrates two typical designs of closure, types A and B.
© ISO 2010 – All rights reserved 1
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SIST EN ISO 8536-2:2010
ISO 8536-2:2010(E)
Dimensions in millimetres
Figure 1 — Dimensions and configuration of type A and type B closures
...
SLOVENSKI STANDARD
oSIST prEN ISO 8536-2:2009
01-marec-2009
Infuzijska oprema za uporabo v medicini - 2. del: Zapirala za infuzijske steklenice
(ISO/DIS 8536-2:2008)
Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO/DIS 8536-
2:2008)
Infusionsgeräte zur medizinischen Verwendung - Teil 2: Stopfen für Infusionsflaschen
(ISO/DIS 8536-2:2008)
Matériel de perfusion à usage médical - Partie 2: Bouchons pour flacons de perfusion
(ISO/DIS 8536-2:2008)
Ta slovenski standard je istoveten z: prEN ISO 8536-2
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
oSIST prEN ISO 8536-2:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 8536-2:2009
---------------------- Page: 2 ----------------------
oSIST prEN ISO 8536-2:2009
EUROPEAN STANDARD
DRAFT
prEN ISO 8536-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2008
ICS 11.040.20 Will supersede EN ISO 8536-2:2002
English Version
Infusion equipment for medical use - Part 2: Closures for
infusion bottles (ISO/DIS 8536-2:2008)
Matériel de perfusion à usage médical - Partie 2: Bouchons Infusionsgeräte zur medizinischen Verwendung - Teil 2:
pour flacons de perfusion (ISO/DIS 8536-2:2008) Stopfen für Infusionsflaschen (ISO/DIS 8536-2:2008)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/SS S02.
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 Management Centre has the
same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland 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.
: This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
Warning
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 8536-2:2008: E
worldwide for CEN national Members.
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oSIST prEN ISO 8536-2:2009
prEN ISO 8536-2:2008 (E)
Contents Page
Foreword .3
2
---------------------- Page: 4 ----------------------
oSIST prEN ISO 8536-2:2009
prEN ISO 8536-2:2008 (E)
Foreword
This document (prEN ISO 8536-2:2008) has been prepared by Technical Committee ISO/TC 76 "Transfusion,
infusion and injection equipment for medical and pharmaceutical use" in collaboration with Technical
CommitteeCEN/SS S02 “Transfusion equipment” the secretariat of which is held by CMC.
This document is currently submitted to the parallel Enquiry.
This document will supersede EN ISO 8536-2:2002.
Endorsement notice
The text of ISO/DIS 8536-2:2008 has been approved by CEN as a prEN ISO 8536-2:2008 without any
modification.
3
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oSIST prEN ISO 8536-2:2009
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oSIST prEN ISO 8536-2:2009
DRAFT INTERNATIONAL STANDARD ISO/DIS 8536-2
ISO/TC 76 Secretariat: DIN
Voting begins on: Voting terminates on:
2008-12-11 2009-05-11
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Infusion equipment for medical use —
Part 2:
Closures for infusion bottles
Matériel de perfusion à usage médical —
Partie 2: Bouchons pour flacons de perfusion
[Revision of second edition (ISO 8536-2:2001)]
ICS 11.040.20
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.
To expedite distribution, this document is circulated as received from the committee secretariat.
ISO Central Secretariat work of editing and text composition will be undertaken at publication
stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
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.
©
International Organization for Standardization, 2008
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oSIST prEN ISO 8536-2:2009
ISO/DIS 8536-2
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.
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user's country, neither this ISO draft nor any extract from it may be
reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying,
recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to 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
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
©
ii ISO 2008 – All rights reserved
---------------------- Page: 8 ----------------------
oSIST prEN ISO 8536-2:2009
ISO/DIS 8536-2
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Shape and dimensions .1
4 Designation .3
5 Material .3
6 Performance.3
6.1 General .3
6.2 Physical requirements .3
6.3 Chemical requirements.4
6.4 Biological requirements.4
7 Labelling.4
Annex A (normative) Determination of fragments .5
A.1 Principle .5
A.2 Apparatus.5
A.3 Procedure.5
A.4 Reference testing .6
A.5 Expression of results.6
A.6 Validity.6
Annex B (normative) Determination of spike penetration force .7
B.1 Principle .7
B.2 Apparatus.7
B.3 Procedure.7
B.4 Expression of results.8
Annex C (normative) Spike retention/sealability .9
C.1 Principle .9
C.2 Apparatus.9
C.3 Procedure.9
C.4 Expression of results.9
Annex D (normative) Closure piercing device.10
Bibliography.11
© ISO 2008 – All rights reserved iii
---------------------- Page: 9 ----------------------
oSIST prEN ISO 8536-2:2009
ISO/DIS 8536-2
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 8536-2 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment
for medical and pharmaceutical use.
This third edition cancels and replaces the second edition (ISO 8536-2:2001), which has been technically
revised in order to align this Standard with ISO 8871-1, ISO 8871-4 and ISO 8871-5.
ISO 8536 consists of the following parts, under the general title Infusion equipment for medical use:
⎯ Part 1: Infusion glass bottles
⎯ Part 2: Closures for infusion bottles
⎯ Part 3 Aluminium caps for infusion bottles
⎯ Part 4: Infusion sets for single use, gravity feed
⎯ Part 5: Burette infusion sets for single use, gravity feed
⎯ Part 6: Freeze drying closures for infusion bottles
⎯ Part 7: Caps made of aluminium-plastics combinations for infusion bottles
⎯ Part 8: Infusion equipment for use with pressure infusion apparatus
⎯ Part 9: Fluid lines for use with pressure infusion equipment
⎯ Part 10: Accessories for fluid lines for use with pressure infusion equipment
⎯ Part 11: Infusion filters for use with pressure infusion equipment
iv © ISO 2008 – All rights reserved
---------------------- Page: 10 ----------------------
oSIST prEN ISO 8536-2:2009
ISO/DIS 8536-2
Introduction
The purpose of this part of ISO 8536 is to specify the shape and dimensions of and the requirements for
elastomeric closures intended for infusion bottles. In order to provide seal integrity of the container closure
systems the dimensions of the elastomeric closures have to be compatible with the dimensions of the infusion
bottles and the caps as specified in corresponding parts of ISO 8536.
Primary packaging components made of elastomeric materials are an integral part of medicinal products and
thus the principles of current Good Manufacturing Practices (cGMP) apply to the manufacturing of these
components.
Principles of cGMP are described in e. g. ISO 15378 or GMP Guidelines as published by the European
Community and the United States of America.
© ISO 2008 – All rights reserved v
---------------------- Page: 11 ----------------------
oSIST prEN ISO 8536-2:2009
---------------------- Page: 12 ----------------------
oSIST prEN ISO 8536-2:2009
DRAFT INTERNATIONAL STANDARD ISO/DIS 8536-2
Infusion equipment for medical use —
Part 2:
Closures for infusion bottles
1 Scope
This part of ISO 8536 specifies the shape, dimensions, material, performance require
...
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