EN ISO 8536-2:2002

Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2001)

Infusionsgeräte zur medizinischen Verwendung - Teil 2: Stopfen für Infusionsflaschen (ISO 8536-2:2001)

Diese Internationale Norm legt Form, Maße, Werkstoff sowie weitere Anforderungen und Prüfungen von Stopfen für Infusionsflaschen nach ISO 8536-1 fest.
Die hierin beschriebenen Stopfen sind nur zur einmaligen Verwendung bestimmt.

Matériel de perfusion à usage médical - Partie 2: Bouchons pour flacons de perfusion (ISO 8536-2:2001)

Infuzijska oprema za uporabo v medicini - 2. del: Zapirala za infuzijske steklenice (ISO 8536-2:2001)

General Information

• Status: Withdrawn
• Publication Date: 24-Sep-2002
• Withdrawal Date: 14-Mar-2010
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/SS S02 - Transfusion equipment
• Drafting Committee: CEN/SS S02 - Transfusion equipment
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 15-Mar-2010
• Completion Date: 15-Mar-2010
• Ref Project: SIST EN ISO 8536-2:2003 - Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2001)

Relations

• Replaces: EN ISO 8536-2:1999/AC:1999 - Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:1992)
• Effective Date: 22-Dec-2008
• Replaces: EN ISO 8536-2:1999 - Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:1999)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 8536-2:2010 - Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2010)
• Effective Date: 08-Jun-2022
• Corrected By: EN ISO 8536-2:2002/AC:2005 - Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2001)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8536-2:2003
01-marec-2003
1DGRPHãþD
SIST EN ISO 8536-2:2000
SIST EN ISO 8536-2:2000/AC:2000
Infuzijska oprema za uporabo v medicini - 2. del: Zapirala za infuzijske steklenice
(ISO 8536-2:2001)
Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-
2:2001)
Infusionsgeräte zur medizinischen Verwendung - Teil 2: Stopfen für Infusionsflaschen
(ISO 8536-2:2001)
Matériel de perfusion a usage médical - Partie 2: Bouchons pour flacons de perfusion
(ISO 8536-2:2001)
Ta slovenski standard je istoveten z: EN ISO 8536-2:2002
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8536-2:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 8536-2:2003

---------------------- Page: 2 ----------------------

SIST EN ISO 8536-2:2003
EUROPEAN STANDARD
EN ISO 8536-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2002
ICS 11.040.20 Supersedes EN ISO 8536-2:1999
English version
Infusion equipment for medical use - Part 2: Closures for
infusion bottles (ISO 8536-2:2001)
Matériel de perfusion à usage médical - Partie 2: Bouchons Infusionsgeräte zur medizinischen Verwendung - Teil 2:
pour flacons de perfusion (ISO 8536-2:2001) Stopfen für Infusionsflaschen (ISO 8536-2:2001)
This European Standard was approved by CEN on 30 August 2002.
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, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, 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
© 2002 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-2:2002 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 8536-2:2003
EN ISO 8536-2:2002 (E)
CORRECTED 2002-11-13
Foreword
The text of ISO 8536-2:2001 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 8536-2:2002 by the
Technical Board of CEN.
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 March 2003, and conflicting national standards
shall be withdrawn at the latest by March 2003.
This document supersedes EN ISO 8536-2:1999.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta,
Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 8536-2:2001 has been approved by CEN as EN ISO 8536-2:2002 without any
modifications.
NOTE Normative references to International Standards are listed in annex ZA (normative).
2

---------------------- Page: 4 ----------------------

SIST EN ISO 8536-2:2003
EN ISO 8536-2:2002 (E)
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of any
of these publications apply to this European Standard only when incorporated in it by amendment or
revision. For undated references the latest edition of the publication referred to applies (including
amendments).
NOTE Where an International Publication has been modified by common modifications, indicated by (mod.), the
relevant EN/HD applies.
Publication Year Title EN/HD Year
ISO 868 1985 Plastics and ebonite - Determination EN ISO 868 1997
of indentation hardness by means of
a durometer (Shore hardness)
ISO 8536-1 1999 Infusion equipment for medical use - EN ISO 8536-1 1999
Part 1: Infusion glass bottles
ISO 8536-3 1999 Infusion equipment for medical use - EN ISO 8536-3 1999
Part 3: Aluminium caps for infusion
bottles
3

---------------------- Page: 5 ----------------------

SIST EN ISO 8536-2:2003

---------------------- Page: 6 ----------------------

SIST EN ISO 8536-2:2003
INTERNATIONAL ISO
STANDARD 8536-2
Second edition
2001-06-15
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 8536-2:2001(E)
©
ISO 2001

---------------------- Page: 7 ----------------------

SIST EN ISO 8536-2:2003
ISO 8536-2:2001(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 2001
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 [e-mail]
Web www.iso.ch
Printed in Switzerland
ii © ISO 2001 – All rights reserved

---------------------- Page: 8 ----------------------

SIST EN ISO 8536-2:2003
ISO 8536-2:2001(E)
Contents Page
Foreword.iv
Introduction.v
1 Scope .1
2 Normative references .1
3 Dimensions and designation.1
3.1 Dimensions.1
3.2 Designation .2
4 Material .3
5 Physical requirements .3
5.1 General.3
5.2 Performance.3
5.3 Hardness.3
5.4 Fragmentation.3
5.5 Spike penetration force.3
5.6 Sealability and spike retention.4
5.7 Storage.4
6 Chemical requirements .4
7 Biological requirements.4
8 Sample .4
9 Marking .4
10 Conformance.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
© ISO 2001 – All rights reserved iii

---------------------- Page: 9 ----------------------

SIST EN ISO 8536-2:2003
ISO 8536-2:2001(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 3.
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 part of ISO 8536 may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 8536-2 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and
injection equipment for medical and pharmaceutical use.
This second edition cancels and replaces the first edition (ISO 8536-2:1992), which has been technically revised.
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-type infusion sets
� Part 6: Freeze drying closures for infusion bottles
� Part 7: Caps made of aluminium-plastics combinations for infusion bottles
Annexes A, B, C and D form a normative part of this part of ISO 8536.
iv © ISO 2001 – All rights reserved

---------------------- Page: 10 ----------------------

SIST EN ISO 8536-2:2003
ISO 8536-2:2001(E)
Introduction
The materials from which injection containers (including elastomeric closures) are made are suitable primary
packaging materials for storing injectable products until they are administered.
© ISO 2001 – All rights reserved v

---------------------- Page: 11 ----------------------

SIST EN ISO 8536-2:2003

---------------------- Page: 12 ----------------------

SIST EN ISO 8536-2:2003
INTERNATIONAL STANDARD ISO 8536-2:2001(E)
Infusion equipment for medical use —
Part 2:
Closures for infusion bottles
1 Scope
This part of ISO 8536 specifies the design, dimensions, material, performance requirements and testing of closures
for infusion bottles as specified in ISO 8536-1.
Closures described herein are intended for single use only.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this part of ISO 8536. For dated references, subsequent amendments to, or revisions of, any of these publications
do not apply. However, parties to agreements based on this part of ISO 8536 are encouraged to investigate the
possibility of appl
...