EN ISO 8536-1:2003
(Main)Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO 8536-1:2000)
Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO 8536-1:2000)
The issue of the standards is stopped due to the necessity to issue a corrigendum taking into account the necessity of a "A deviation" for sweeden. For more details please contact Ludwig Paul at CMC: +32 2 550 08 31.
Expect 2 months delay.
Infusionsgeräte zur medizinischen Verwendung - Teil 1: Infusionsflaschen aus Glas (ISO 8536-1:2000)
Diese Internationale Norm legt Maße, Ausführungen und Anforderungen für Infusionsflaschen aus Glas fest, die erforderlich sind, um die funktionelle Austauschbarkeit sicherzustellen. Diese Internationale Norm gilt nur für Infusionsflaschen zur einmaligen Verwendung.
Matériel de perfusion à usage médical - Partie 1: Flacons en verre pour perfusion (ISO 8536-1:2000)
Infuzijska oprema za uporabo v medicini - 1. del: Infuzijske steklenice (ISO 8536-1:2000)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8536-1:2003
01-september-2003
1DGRPHãþD
SIST EN ISO 8536-1:2000
SIST EN ISO 8536-1:2000/AC:2000
Infuzijska oprema za uporabo v medicini - 1. del: Infuzijske steklenice (ISO 8536-
1:2000)
Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO 8536-1:2000)
Infusionsgeräte zur medizinischen Verwendung - Teil 1: Infusionsflaschen aus Glas (ISO
8536-1:2000)
Matériel de perfusion a usage médical - Partie 1: Flacons en verre pour perfusion (ISO
8536-1:2000)
Ta slovenski standard je istoveten z: EN ISO 8536-1:2003
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8536-1:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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EUROPEAN STANDARD
EN ISO 8536-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2003
ICS 11.040.20 Supersedes EN ISO 8536-1:1999
English version
Infusion equipment for medical use - Part 1: Infusion glass
bottles (ISO 8536-1:2000)
Matériel de perfusion à usage médical - Partie 1: Flacons Infusionsgeräte zur medizinischen Verwendung - Teil 1:
en verre pour perfusion (ISO 8536-1:2000) Infusionsflaschen aus Glas (ISO 8536-1:2000)
This European Standard was approved by CEN on 27 December 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,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, 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
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-1:2003 E
worldwide for CEN national Members.
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EN ISO 8536-1:2003 (E)
Foreword
The text of ISO 8536-1:2000 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-
1:2003 by CMC.
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 November 2003, and conflicting national
standards shall be withdrawn at the latest by November 2003.
This document supersedes EN ISO 8536-1:1999.
For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this
document.
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, Hungary, Iceland, Ireland, Italy,
Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and
the United Kingdom.
Endorsement notice
The text of ISO 8536-1:2000 has been approved by CEN as EN ISO 8536-1:2003 without any
modifications.
2
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EN ISO 8536-1:2003 (E)
Annex ZA
(informative)
A-deviations
A-deviation: National deviation due to regulations, the alteration of which is for the time being
outside the competence of CEN/CENELEC member:
NOTE: Where standards fall under EC Directives it is the view of the Commission of the
European Communities (OJ No G 59, 9.3, 1982) that the effect of the decision of the Court of
Justice in case 815/79 Cremonini/Vrankovitch (European Court Reports 1980, p.3583) is that
compliance with A-deviations is no longer mandatory and that the free movement of products
complying with such a standard should not be restricted except under the safeguard procedure
provided for in the relevant Directive.
A-deviations in an EFTA country are valid instead of the relevant provisions of the European
Standard in that country until they have been removed.
The European Standard is not in agreement with the European Pharmacopoeia 2nd edition
VI.2.3.1, which is mandatory in Sweden, by LVFS 1996:16.
3
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INTERNATIONAL ISO
STANDARD 8536-1
Second edition
2000-06-15
Infusion equipment for medical use —
Part 1:
Infusion glass bottles
Matériel de perfusion à usage médical —
Partie 1: Flacons en verre pour perfusion
Reference number
ISO 8536-1:2000(E)
©
ISO 2000
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ISO 8536-1:2000(E)
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ii © ISO 2000 – All rights reserved
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ISO 8536-1:2000(E)
Contents Page
Foreword.iv
Introduction.v
1 Scope .1
2 Normative references .1
3 Terms and definitions .1
4 Dimensions and designation.2
5 Material .4
6 Performance.5
7 Requirements.5
8 Marking .5
© ISO 2000 – All rights reserved iii
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ISO 8536-1:2000(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 8536-1 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and
injectio
...
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