SIST EN ISO 23328-1:2008

Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance (ISO 23328-1:2003)

This part of ISO 23328 gives a short-term airborne sodium chloride particle challenge test method for
assessing the filtration performance of breathing system filters (BSF) intended for the filtration of respired
gases.
This part of ISO 23328 is applicable to BSF used with a clinical breathing system. It is not applicable to other
types of filter, e.g. those designed to protect vacuum sources or gas sample lines, to filter compressed gases,
or to protect test equipment for physiological respiratory measurements.
NOTE Non-filtration aspects of BSF are addressed in ISO 23328-2.

Filter für Atemsysteme zur Anwendung bei Anästhesie und Beatmung - Teil 1: Prüfverfahren mit Salzpartikeln zur Bewertung der Filterleistung (ISO 23328-1:2003)

Dieser Teil von ISO 23328 legt ein nur kurze Zeit in Anspruch nehmendes Prüfverfahren fest, bei dem die Beaufschlagung mit luftgetragenen Natriumchloridpartikeln erfolgt. Das Verfahren dient der Bewertung der Filterleistung von Atemsystemfiltern (ASF), die zur Filtration von Atemgasen des Menschen vorgesehen sind.
Dieser Teil von ISO 23328 ist für ASF bestimmt, die im Zusammenhang mit einem klinischen Beatmungssystem angewendet werden. Es ist nicht anwendbar auf andere Filtertypen, z. B. Filter zum Schutz von Vakuumquellen oder von Leitungen zur Probenahme von Gasen, zur Filtration komprimierter Gase oder zum Schutz von Prüfeinrichtungen für physiologische Atmungsmessungen.
ANMERKUNG   Aspekte von Atemsystemfiltern, die nicht die Filtration betreffen, sind in ISO 13328-2 enthalten.

Filtres pour matériel d'anesthésie et de réanimation respiratoire - Partie 1 : Méthode d'essai à l'aide d'une solution saline pour l'évaluation de la performance de la filtration (ISO 23328-1:2003)

L'ISO 23328-1:2003 présente une méthode d'essai d'exposition à court terme à des particules de chlorure de sodium en suspension dans l'air, visant à évaluer les performances de filtration des filtres pour systèmes respiratoires (BSF) prévus pour la filtration des gaz respirés par les êtres humains.
L'ISO 23328-1:2003 est applicable aux BSF utilisés avec un système respiratoire clinique. Elle ne s'applique pas aux autres types de filtration, par exemple à ceux conçus pour protéger les sources de vides ou les tubes d'échantillonnage de gaz, pour filtrer les gaz comprimés ou pour protéger le matériel d'essai destiné à effectuer des mesurages respiratoires physiologiques.

Sistem dihalnih filtrov za anestezijsko in dihalno uporabo - 1. del: Preskusna metoda s soljo za ocenitev učinkovitosti filtracije (ISO 23328-1:2003)

General Information

• Status: Published
• Publication Date: 08-Jun-2008
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 07-May-2008
• Due Date: 12-Jul-2008
• Completion Date: 09-Jun-2008
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 23328-1:2008 - Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance (ISO 23328-1:2003)

Relations

• Replaces: SIST EN 13328-1:2002 - Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance
• Effective Date: 01-Jul-2008

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 23328-1:2008
01-julij-2008
1DGRPHãþD
SIST EN 13328-1:2002
6LVWHPGLKDOQLKILOWURY]DDQHVWH]LMVNRLQGLKDOQRXSRUDERGHO3UHVNXVQD
PHWRGDVVROMR]DRFHQLWHYXþLQNRYLWRVWLILOWUDFLMH,62
Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to
assess filtration performance (ISO 23328-1:2003)
Filter für Atemsysteme zur Anwendung bei Anästhesie und Beatmung - Teil 1:
Prüfverfahren mit Salzpartikeln zur Bewertung der Filterleistung (ISO 23328-1:2003)
Filtres pour matériel d'anesthésie et de réanimation respiratoire - Partie 1 : Méthode
d'essai à l'aide d'une solution saline pour l'évaluation de la performance de la filtration
(ISO 23328-1:2003)
Ta slovenski standard je istoveten z: EN ISO 23328-1:2008
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 23328-1:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 23328-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2008
ICS 11.040.10 Supersedes EN 13328-1:2001
English Version
Breathing system filters for anaesthetic and respiratory use -
Part 1: Salt test method to assess filtration performance (ISO
23328-1:2003)
Filtres pour matériel d'anesthésie et de réanimation Filter für Atemsysteme zur Anwendung bei Anästhesie und
respiratoire - Partie 1: Méthode d'essai à l'aide d'une Beatmung - Teil 1: Prüfverfahren mit Salzpartikeln zur
solution saline pour l'évaluation de l'efficacité de filtration Bewertung der Filterleistung (ISO 23328-1:2003)
(ISO 23328-1:2003)
This European Standard was approved by CEN on 24 February 2008.
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, 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: rue de Stassart, 36  B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23328-1:2008: E
worldwide for CEN national Members.

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EN ISO 23328-1:2008 (E)
Contents Page
Foreword.3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical devices .4

2

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EN ISO 23328-1:2008 (E)
Foreword
The text of ISO 23328-1:2003 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 23328-1:2008 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic 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 or by endorsement, at the latest by September 2008, and conflicting national standards shall be
withdrawn at the latest by September 2008.
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 13328-1:2001.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directive(s).
For relationship with EC Directive(s), see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this Europea
...