EN ISO 23328-2:2008
(Main)Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002)
Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (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.
Filter für Atemsysteme zur Anwendung bei Anästhesie und Beatmung - Teil 2: Aspekte, die nicht die Filtration betreffen (ISO 23328-2:2002)
Dieser Teil von ISO 23328 legt Anforderungen an Atemsystemfilter (ASF) für Anwendungen bei Anästhesie und Beatmung fest, die nicht die Filtration betreffen, und behandelt Anschlüsse, Leckage, Durchfluss¬widerstand, Verpackung, Aufschriften und Informationen des Herstellers. Das Prüfverfahren ist für ASF vorgesehen, die mit einem klinischen Atemsystem verwendet werden.
Dieser Teil ist nicht anwendbar auf andere Arten von Filtern, z. B. Filter zum Schutz von Vakuumquellen oder Gasprobenentnahmeleitungen, Filter zur Filtration von Druckgasen oder Filter zum Schutz von Prüfein¬rich¬tungen, die bei physiologischen Atemmessungen eingesetzt werden.
ANMERKUNG Ein Verfahren zur Bewertung der Filterleistung von ASF ist in ISO 23328-1 enthalten.
Filtres pour matériel d'anesthésie et de réanimation respiratoire - Partie 2: Aspects autres que la filtration (ISO 23328-2:2002)
Sistem dihalnih filtrov za anestezijsko in dihalno uporabo - 2. del: Nefiltracijski vidiki (ISO 23328-2:2002)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2008
1DGRPHãþD
SIST EN 13328-2:2003
SIST EN 13328-2:2003/A1:2004
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 filtration (ISO 23328-2:2002)
Ta slovenski standard je istoveten z: EN ISO 23328-2:2008
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 23328-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2008
ICS 11.040.10 Supersedes EN 13328-2:2002
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 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 23328-2:2008: 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 23328-2:2002 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 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 13328-2:2002.
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 23328-2:2002 has been approved by CEN as a EN ISO 23328-2:2008 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
4 1, 2, 3, 4, 7.5, 9.1
5 3, 4, 7.5, 7.6
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
7.3c) 8.7, 13.3c)
7.4 13.3b), f)
8 13.1, 13.6a), b)
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 product(s) falling within
the scope of this 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.
...
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