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)

ISO 23328-1:2003 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.
ISO 23328-1:2003 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.
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 l'efficacité de 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: 18-Mar-2008
• Withdrawal Date: 29-Sep-2008
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 4 - Tracheal tubes and other equipment
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 19-Mar-2008
• Due Date: 03-Apr-2009
• Completion Date: 19-Mar-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: 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)

Relations

• Replaces: EN 13328-1:2001 - Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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

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
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 European Standard: 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 the United Kingdom.
Endorsement notice
The text of ISO 23328-1:2003 has been approved by CEN as a EN ISO 23328-1:2008 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC Medical devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC Medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in table ZA confers, within the limits of the scope of this standard, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA — Correspondence between this European Standard and Directive (Add the reference and
title of the Directive)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
EN Directive 93/42/EEC Medical
devices
This standard is intended to
All
provide a test method that will
allow evaluation of the
performance of filters intended
for use within clinical breathing
systems and will improve
comparability of results
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 23328-1
First edition
2003-08-15
Breathing system filters for anaesthetic
and respiratory use —
Part 1:
Salt test method to assess filtration
performance
Filtres pour matériel d'anesthésie et de réanimation respiratoire —
Partie 1: Méthode d'essai saline pour l'évaluation de l'efficacité de
filtration
Reference number
ISO 23328-1:2003(E)
©
ISO 2003
ISO 23328-1:2003(E)
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ii © ISO 2003 — All rights reserved

ISO 23328-1:2003(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Terms and definitions. 1
3 Method. 2
3.1 Principle. 2
3.2 Test conditions. 2
3.3 Apparatus. 2
3.4 Conditioning of BSF . 2
3.5 Sample size. 3
3.6 Procedure. 3
4 Calculation and expression of test results. 4
5 Test report. 4
Annex A (normative) Conditioning of BSF . 5
Annex B (informative) Aerosol particle size distribution . 8
Annex C (informative) Rationale for chosen test method . 9
Annex D (informative) Clauses of this part of ISO 23328 addressing the essential principles of
ISO/TR 16142 . 11
Bibliography . 12

ISO 23328-1:2003(E)
Foreword
ISO (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 ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International 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 patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 23328-1 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 3, Lung ventilators and related equipment.
ISO 23328 consists of the following parts, under the general title Breathing system filters for anaesthetic and
respiratory use:
 Part 1: Salt test method to assess filtration performance
 Part 2: Non-filtration aspects
iv © ISO 2003 — All rights reserved

ISO 23328-1:2003(E)
Introduction
This part of ISO 23328 gives a method of test for assessing the filtration performance of breathing system
filters (BSF).
BSF are used to reduce the number of particulates, including microorganisms, in gases delivered to, and
exhaled from, patients.
BSF are exposed to various levels of humidity during clinical use. Exposure of the BSF to humidified air to
simulate clinical use forms part of this method (see Annex A), as it is possible that such exposure can
influence the filtration performance of the BSF.
In the test, the BSF is challenged with sodium chloride particles of the most penetrating size range, i.e. 0,1 µm
to 0,3 µm (see Annex C).
It is recognized that transmission of microorganisms across a filter can occur due to “channeling” and
“grow-through”. There are at present no accepted methods to quantify these occurrences. This test method is
for comparison purposes only, and has no proven clinical relevance. The results are specific to the test
method and no risk factor should be derived from it.
...