EN ISO 8536-11:2004

Infusion equipment for medical use - Part 11: Infusion filters for use with pressure infusion equipment (ISO 8536-11:2004)

ISO 8536-11:2004 applies to sterilized infusion filters for single use up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in ISO 8536-8. It does not include the effectiveness of filters for separation of particles or germs.

Infusionsgeräte zur medizinischen Verwendung - Teil 11: Infusionsfilter zur Verwendung mit Druckinfusionsapparaten (ISO 8536-11:2004)

Dieser Teil von ISO 8536 gilt für sterilisierte, zur einmaligen Verwendung bis 200 kPa (2 bar) bestimmte und mit Übertragungsleitungen von Druckinfusionsapparaten und Infusionsgeräten nach ISO 8536-8 verwendete Infusionsfilter. Diese Norm befasst sich nicht mit der Wirksamkeit von Filtern zur Abscheidung von Partikeln oder Keimen.

Matériel de perfusion à usage médical - Partie 11: Filtres de perfusion pour utilisation avec des appareils de perfusion sous pression (ISO 8536-11:2004)

L'ISO 8536-11:2004 s'applique aux filtres à perfusion stériles à usage unique soumis à une pression maximale de 200 kPa (2 bar) sur les tubulures des appareils de perfusion sous pression et du matériel de perfusion spécifiés dans l'ISO 8536-8. Elle ne traite pas l'efficacité des filtres en matière de séparation des particules ou de séparation des germes.

Infuzijska oprema za uporabo v medicini - 11. del: Infuzijski filtri za uporabo z infuzijsko opremo, delujočo na osnovi tlaka (ISO 8536-11:2004)

General Information

• Status: Withdrawn
• Publication Date: 30-Nov-2004
• Withdrawal Date: 16-Jun-2015
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 17-Jun-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN ISO 8536-11:2005 - Infusion equipment for medical use - Part 11: Infusion filters for use with pressure infusion equipment (ISO 8536-11:2004)

Relations

• Replaced By: EN ISO 8536-11:2015 - Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015)
• Effective Date: 24-Jun-2015

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Infusionsgeräte zur medizinischen Verwendung - Teil 11: Infusionsfilter zur Verwendung mit Druckinfusionsapparaten (ISO 8536-11:2004)Matériel de perfusion a usage médical - Partie 11: Filtres de perfusion pour utilisation avec des appareils de perfusion sous pression (ISO 8536-11:2004)Infusion equipment for medical use - Part 11: Infusion filters for use with pressure infusion equipment (ISO 8536-11:2004)11.040.20Transfuzijska, infuzijska in injekcijska opremaTransfusion, infusion and injection equipmentICS:Ta slovenski standard je istoveten z:EN ISO 8536-11:2004SIST EN ISO 8536-11:2005en01-marec-2005SIST EN ISO 8536-11:2005SLOVENSKI
STANDARD



SIST EN ISO 8536-11:2005



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 8536-11December 2004ICS 11.040.20English versionInfusion equipment for medical use - Part 11: Infusion filters foruse with pressure infusion equipment (ISO 8536-11:2004)Matériel de perfusion à usage médical - Partie 11: Filtresde perfusion pour utilisation avec des appareils deperfusion sous pression (ISO 8536-11:2004)This European Standard was approved by CEN on 30 September 2004.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2004 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 8536-11:2004: ESIST EN ISO 8536-11:2005



EN ISO 8536-11:2004 (E) 2
Foreword
This document (EN ISO 8536-11:2004) has been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection equipment for medical and pharmaceutical use" in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices", the secretariat of which is held by BSI.
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 June 2005, and conflicting national standards shall be withdrawn at the latest by June 2005.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 8536-11:2004 has been approved by CEN as EN ISO 8536-11:2004 without any modifications. SIST EN ISO 8536-11:2005



INTERNATIONALSTANDARDISO8536-11First edition2004-10-01Reference numberISO8536-11:2004(E)© ISO2004Infusion equipment for medical use—Part11:Infusion filters for use with pressure infusion equipmentMatériel de perfusion à usage médical—Partie11: Filtres de perfusion pour utilisation avec des appareils de perfusion sous pression
SIST EN ISO 8536-11:2005



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