EN ISO 23328-2:2009

Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002)

ISO 23328-2:2002 specifies requirements for non-filtration aspects of breathing system filters (BSF) intended for anaesthetic and respiratory use, and addresses connection ports, leakage, resistance to flow, packaging, marking and information supplied. The test method is intended for 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.
A method for assessing filtration performance of BSF is given in ISO 23328-1.

Filter für Atemsysteme zur Anwendung bei Anästhesie und Beatmung - Teil 2: Aspekte, die nicht die Filtration betreffen (ISO 23328-2:2002)

Filtres pour matériel d'anesthésie et de réanimation respiratoire - Partie 2: Aspects autres que la filtration (ISO 23328-2:2002)

L'ISO 23328-2:2002 spécifie les exigences s'appliquant aux aspects autres que la filtration des filtres pour systèmes respiratoires (BSF) pour matériel d'anesthésie et de réanimation. Elle traite des orifices de raccordement, des fuites, de la résistance au débit, de l'emballage, du marquage et des informations fournies. La méthode d'essai est destinée aux BSF utilisés avec un système respiratoire clinique.
L'ISO 23328-2:2002 ne s'applique pas aux autres types de filtres, par exemple ceux conçus pour protéger les sources de vide ou les lignes de prélèvement de gaz, pour filtrer les gaz comprimés ou pour protéger le matériel d'essai utilisé pour les mesurages respiratoires physiologiques.

Sistem dihalnih filtrov za anestezijsko in dihalno uporabo - 2. del: Nefiltracijski vidiki (ISO 23328-2:2002)

General Information

• Status: Published
• Publication Date: 10-Mar-2009
• Withdrawal Date: 20-Mar-2010
• 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: 11-Mar-2009
• Completion Date: 11-Mar-2009
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• 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: SIST EN ISO 23328-2:2009 - Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002)

Relations

• Replaces: EN ISO 23328-2:2008 - Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002)
• Effective Date: 23-Mar-2009

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2009
1DGRPHãþD
SIST EN ISO 23328-2:2008
Sistem dihalnih filtrov za anestezijsko in dihalno uporabo - 2. del: Nefiltracijski
vidiki (ISO 23328-2:2002)
Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration
aspects (ISO 23328-2:2002)
Filter für Atemsysteme zur Anwendung bei Anästhesie und Beatmung - Teil 2: Aspekte,
die nicht die Filtration betreffen (ISO 23328-2:2002)
Filtres pour matériel d'anesthésie et de réanimation respiratoire - Partie 2: Aspects
autres que la filtration (ISO 23328-2:2002)
Ta slovenski standard je istoveten z: EN ISO 23328-2:2009
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 23328-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2009
ICS 11.040.10 Supersedes EN ISO 23328-2:2008
English Version
Breathing system filters for anaesthetic and respiratory use -
Part 2: Non-filtration aspects (ISO 23328-2:2002)
Filtres pour matériel d'anesthésie et de réanimation Filter für Atemsysteme zur Anwendung bei Anästhesie und
respiratoire - Partie 2: Aspects autres que la filtration (ISO Beatmung - Teil 2: Aspekte, die nicht die Filtration betreffen
23328-2:2002) (ISO 23328-2:2002)
This European Standard was approved by CEN on 24 February 2009.
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: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23328-2:2009: 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 .4

Foreword
The text of ISO 23328-2:2002 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 2009, and conflicting national standards shall be
withdrawn at the latest by March 2010.
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 ISO 23328-2:2008.
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.
For relationship with EC Directive, 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 23328-2:2002 has been approved by CEN as a EN ISO 23328-2:2009 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
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 on 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. - Relationship between this European Standard and the Essential Requirements of EU
Directive 93/42/EEC
Clause(s)/sub- Essential Requirements (ERs) of Qualifying remarks/Notes
clause(s) of this EN Directive 93/42/EEC
4 1, 2, 3, 4, 7.5, 9.1
5 3, 4, 7.5, 7.6
6a This relevant Essential
-
Requirement is not addressed in
this European Standard
7.5 (1st paragraph) This relevant Essential
5.3
Requirement is not fully
addressed in this European
Standard
7.5 (2nd paragraph) This relevant Essential
-
Requirement is not addressed in
this European Standard
7.5 (3rd paragraph) This relevant Essential
-
Requirement is not addressed in
this European Standard
6 2, 5, 7.2, 8.1, 8.3, 8.4, 8.5
7 13.1
7.1 13.2
7.2 13.1, 13.2, 13.3j), 13.6c)
7.3 13.3a), b), c), d), e), i), 13.4, 13.5
13.3 (a): This relevant Essential
7.3
Requirement is not fully
addressed in this European
Standard
7.3c) 8.7, 13.3c)
7.4 13.3b), f)
13.3 (f) This relevant Essential
7.4
Requirement is not fully
addressed in this European
Standard
8 13.1, 13.6a), b)
13.6 (h)(2nd paragraph) This relevant Essential
Requirement is not fully
addressed in this European
Standard
13.6 (q) This relevant Essential
-
Requirement is not addressed in
this European Standard
8a) 13.6d)
8f) 13.6f), m)
8g) 8.7, 13.3m), 13.6d), g), h), i)
8i) 13.6n)
8k) 13.6c)
Warning – Other requirements and other EU Directives may be applicable to the products falling within the
scope of this International standard.

INTERNATIONAL ISO
STANDARD 23328-2
First edition
2002-10-15
Breathing system filters for anaesthetic and
respiratory use —
Part 2:
Non-filtration aspects
Filtres pour matériel d'anesthésie et de réanimation respiratoire —
Partie 2: Aspects autres que filtration

Reference number
ISO 23328-2:2002(E)
©
ISO 2002
ISO 23328-2:2002(E)
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ISO 23328-2:2002(E)
Contents Page
Foreword . iv
Introduction. v
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 1
4 BSF port connectors. 2
4.1 BSF breathing system and patient connection ports. 2
4.2 Accessory ports . 2
5 Test methods . 2
5.1 Ambient conditions of test. 2
5.2 Measurement of pressure drop . 2
5.3 Test for gas leakage. 3
6 Packaging of sterile BSF . 3
7 Marking. 3
7.1 Use of symbols. 3
7.2 Marking of BSF . 3
7.3 Marking of package. 3
7.4 BSF intended for single use. 3
8 Information to be provided by the manufacturer. 4
Bibliography. 5

ISO 23328-2:2002(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 3.
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 part of ISO 23328 may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 23328-2 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 sys
...