Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2010)

ISO 8536‑2:2010 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 ISO 8536‑2:2010 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 zum einmaligen Gebrauch 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

Status
Published
Publication Date
14-Mar-2010
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
15-Mar-2010
Completion Date
15-Mar-2010

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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

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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.

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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

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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.
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Published in Switzerland
ii © ISO 2010 – All rights reserved
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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
...

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