SIST EN 13328-2:2003

Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects

Specifies non-filtration aspects including connectors, leakage

Filter für Atemsysteme zur Anwendung bei Anästhesie und Beatmung - Teil 2: Aspekte, die nicht die Filtration betreffen

Filtres pour systemes respiratoires utilisés en anesthésie et soins respiratoires - Partie 2: Propriétés autres que la filtration

Sistem dihalnih filtrov za anestezijsko in dihalno uporabo - 2. del: Nefiltracijski vidiki

General Information

• Status: Withdrawn
• Publication Date: 28-Feb-2003
• Withdrawal Date: 11-May-2008
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 07-May-2008
• Due Date: 30-May-2008
• Completion Date: 12-May-2008
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN 13328-2:2002 - Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects

Relations

• Amended By: SIST EN 13328-2:2003/A1:2004 - Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects
• Effective Date: 22-Dec-2008
• Replaced By: SIST EN ISO 23328-2:2008 - Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002)
• Effective Date: 01-Jul-2008

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspectsSistem dihalnih filtrov za anestezijsko in dihalno uporabo - 2. del: Nefiltracijski vidikiFiltres pour systemes respiratoires utilisés en anesthésie et soins respiratoires - Partie 2: Propriétés autres que la filtrationFilter für Atemsysteme zur Anwendung bei Anästhesie und Beatmung - Teil 2: Aspekte, die nicht die Filtration betreffen11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:SIST EN 13328-2:2003enTa slovenski standard je istoveten z:EN 13328-2:200201-marec-2003SIST EN 13328-2:2003SLOVENSKI
STANDARD







EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13328-2November 2002ICS 11.040.10English versionBreathing system filters for anaesthetic and respiratory use -Part 2: Non-filtration aspectsFiltres pour systèmes respiratoires utilisés en anesthésie etsoins respiratoires - Partie 2: Propriétés autres que lafiltrationFilter für Atemsysteme zur Anwendung bei Anästhesie undBeatmung - Teil 2: Aspekte, die nicht die Filtration betreffenThis European Standard was approved by CEN on 8 August 2002.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 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 translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2002 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13328-2:2002 E



2ContentspageForeword.31Scope.42Normative references.43Terms and definitions.44BSF port connectors.54.1Breathing system and patient connection ports.54.2Accessory ports.55Test methods.55.1Ambient conditions of test.55.2Measurement of pressure drop.55.3Test method for gas leakage.56Requirements for BSFs supplied sterile.56.1Sterility assurance.56.2Packaging of BSFs supplied sterile.57Marking.67.1Use of symbols.67.2Marking of BSF.67.3Marking of package.67.4BSF intended for single use.68Information to be provided by the manufacturer.6Annex ZA (informative)
Clauses of this European Standard addressing essential requirements or otherprovisions of EU Directives.8



EN 13328-2:2002 (E)3ForewordThis document (EN 13328-2:2002) has been prepared by Technical Committee CEN /TC 215, "Respiratory andanaesthetic equipment", 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 orby endorsement, at the latest by May 2003, and conflicting national standards shall be withdrawn at the latest byMay 2003.This document has been prepared under a mandate given to CEN by the European Commission and the EuropeanFree Trade Association, and supports essential requirements of EU Directive(s).For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.EN 13328 consists of the following parts under the general title Breathing system filters for anaesthetic andrespiratory use :Part 1 : Salt test method to assess filtration performancePart 2 : Non-filtration aspectsAccording to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,Sweden, Switzerland and the United Kingdom.



41 ScopeThis Part of this European Standard specifies requirements for non-filtration aspects of breathing system filters(BSFs) intended for the
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