EN ISO 8536-2:2010

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

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.

Contents Page
Foreword .3

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.

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
ISO 8536-2:2010(E)
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ii © ISO 2010 – All rights reserved

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 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

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.

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 autoclav
...