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)

Applies exclusively to sterilised infusion filters used up to 200 kPa (2 bar) on fluid lines of pressure infusion apparatus and infusion equipment in accordance with EN ISO 8536-4. It does not cover 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 a 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• Status: Withdrawn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: 28-Feb-2005
• Withdrawal Date: 04-Aug-2015
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 03-Aug-2015
• Due Date: 26-Aug-2015
• Completion Date: 05-Aug-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN ISO 8536-11:2004 - Infusion equipment for medical use - Part 11: Infusion filters for use with pressure infusion equipment (ISO 8536-11:2004)

Relations

• Replaced By: SIST 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: 01-Sep-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



ISO8536-11:2004(E)ii© ISO2004–All rights reservedPDF disclaimerThis PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shallnot be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. Indownloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariataccepts 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-creationparameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In theunlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.©ISO2004All 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 orISO's member body in the country of the requester.ISO copyright officeCase postale 56  CH-1211 Geneva 20Tel.+ 41 22 749 01 11Fax+ 41 22 749 09 [e-mail] in SwitzerlandSIST EN ISO 8536-11:2005



ISO8536-11:2004(E)© ISO2004–All rights reservediiiContents Page1Scope . 12Normative references . 13Designation . 14Design . 15Materials . 16Physical requirements . 26.1Transparency . 26.2Particulate contamination . 26.3Tensile strength . 26.4Leakage . 26.5Adapters with female and/or male conical fittings . 26.6Protective caps . 27Chemical requirements . 28Biological requirements . 28.1Sterility . 28.2Pyrogens . 28.3Haemolysis . 39Packaging . 310Labelling . 310.1Unit container . 310.2Shelf or multi-unit container . 3AnnexA(normative)Physical tests . 5AnnexB(normative)Chemical tests . 6AnnexC(normative)Biological tests . 7Bibliography . 8SIST EN ISO 8536-11:2005



ISO8536-11:2004(E)iv© ISO2004–All rights reservedForewordISO (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 ISOtechnical committees. Each member body interested in a subject for which a technical committee has beenestablished has the right to be represented on that committee. International organizations, governmental andnon-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the InternationalElectrotechnical Commission (IEC) on all matters of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part2.The main task of technical committees is to prepare International Standards. Draft International Standardsadopted by the technical committees are circulated to the member bodies for voting. Publication as anInternational 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 document may be the subject of patentrights. ISO shall not be held responsible for identifying any or al
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