EN ISO 8536-2:2010

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• Status: Withdrawn
• Publication Date: 14-Mar-2010
• Withdrawal Date: 14-Feb-2023
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/SS S02 - Transfusion equipment
• Drafting Committee: CEN/SS S02 - Transfusion equipment
• Ref Project: SIST EN ISO 8536-2:2010 - Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2010)

Relations

• Replaces: EN ISO 8536-2:2002 - Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2001)
• Effective Date: 08-Jun-2022
• Replaces: EN ISO 8536-2:2002/AC:2005 - Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2001)
• Effective Date: 20-Mar-2010
• Replaced By: EN ISO 8536-2:2023 - Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2023)
• Effective Date: 19-Jan-2023

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

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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


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