EN ISO 8536-1:2011

Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO/FDIS 8536-1:2011)

ISO 8536-1:2011 specifies the dimensions, performance and requirements of infusion glass bottles necessary to ensure functional interchangeability. It is applicable only to infusion bottles for single use.

Infusionsgeräte zur medizinischen Verwendung - Teil 1: Infusionsflaschen aus Glas (ISO/FDIS 8536-1:2011)

Dieser Teil von ISO 8536 legt Maße, Ausführungen und Anforderungen für Infusionsflaschen aus Glas fest,
die erforderlich sind, um die funktionelle Austauschbarkeit sicherzustellen. Er gilt nur für Infusionsflaschen zur
einmaligen Verwendung.

Matériel de perfusion à usage médical - Partie 1: Flacons en verre pour perfusion (ISO/FDIS 8536-1:2011)

L'ISO 8536-1:2011 spécifie les dimensions, la performance et les exigences relatives aux flacons en verre pour perfusion afin d'assurer leur interchangeabilité. L'ISO 8536-1:2011 ne s'applique qu'aux flacons en verre pour perfusion non réutilisables.

Infuzijska oprema za uporabo v medicini - 1. del: Infuzijske steklenice (ISO 8536-1:2011)

Ta del ISO 8536 določa mere, zmogljivost in zahteve za infuzijske steklenice, ki so potrebne za zagotavljanje funkcionalne izmenljivosti. Velja le za infuzijske steklenice za enkratno uporabo

General Information

• Status: Published
• Publication Date: 31-Aug-2011
• Withdrawal Date: 30-Mar-2012
• 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: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 01-Sep-2011
• Completion Date: 01-Sep-2011
• Ref Project: SIST EN ISO 8536-1:2011 - Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO 8536-1:2011)

Relations

• Replaces: EN ISO 8536-1:2008 - Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO 8536-1:2006)
• Effective Date: 10-Sep-2011

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Infuzijska oprema za uporabo v medicini - 1. del: Infuzijske steklenice (ISO 8536-1:2011)Infusionsgeräte zur medizinischen Verwendung - Teil 1: Infusionsflaschen aus Glas (ISO 8536-1:2011)Matériel de perfusion à usage médical - Partie 1: Flacons en verre pour perfusion (ISO 8536-1:2011)Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO 8536-1:2011)11.040.20Transfuzijska, infuzijska in injekcijska opremaTransfusion, infusion and injection equipmentICS:Ta slovenski standard je istoveten z:EN ISO 8536-1:2011SIST EN ISO 8536-1:2011en,fr,de01-december-2011SIST EN ISO 8536-1:2011SLOVENSKI
STANDARD



SIST EN ISO 8536-1:2011



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 8536-1
September 2011 ICS 11.040.20 Supersedes EN ISO 8536-1:2008English Version
Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO 8536-1:2011)
Matériel de perfusion à usage médical - Partie 1: Flacons en verre pour perfusion (ISO 8536-1:2011)
Infusionsgeräte zur medizinischen Verwendung - Teil 1: Infusionsflaschen aus Glas (ISO 8536-1:2011) This European Standard was approved by CEN on 31 August 2011.
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-CENELEC 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-CENELEC 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 © 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8536-1:2011: ESIST EN ISO 8536-1:2011



EN ISO 8536-1:2011 (E) 2 Contents Page Foreword .3 SIST EN ISO 8536-1:2011



EN ISO 8536-1:2011 (E) 3 Foreword This document (EN ISO 8536-1:2011) has been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection, and blood processing 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 March 2012, and conflicting national standards shall be withdrawn at the latest by March 2012. 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 8536-1:2008. 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 8536-1:2011 has been approved by CEN as a EN ISO 8536-1:2011 without any modification.
SIST EN ISO 8536-1:2011



SIST EN ISO 8536-1:2011



Reference numberISO 8536-1:2011(E)© ISO 2011
INTERNATIONAL STANDARD ISO8536-1Fourth edition2011-09-01Infusion equipment for medical use —
Part 1: Infusion glass bottles Matériel de perfusion à usage médical — Partie 1: Flacons en verre pour perfusion
SIST EN ISO 8536-1:2011



ISO 8536-1:2011(E)
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