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SIST EN ISO 9360-2:2009
01-julij-2009
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Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for
humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized
patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001)
Anästhesie- und Beatmungsgeräte - Wärme- und Feuchtigkeitsaustauscher zur
Anfeuchtung von Atemgasen beim Menschen - Teil 2: Wärme- und
Feuchtigkeitsaustauscher zur Verwendung bei tracheostomierten Patienten mit
Mindesthubvolumina von 250 ml (ISO 9360-2:2001)
Matériel d'anesthésie et de réanimation respiratoire - Échangeurs de chaleur et
d'humidité (ECH) utilisés pour humidifier les gaz respirés par les êtres humains - Partie
2: ECH pour utilisation avec des patients trachéotomisés ayant des volumes courants
d'au moins 250 ml (ISO 9360-2:2001)
Ta slovenski standard je istoveten z: EN ISO 9360-2:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 9360-2:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 9360-2:2009
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SIST EN ISO 9360-2:2009
EUROPEAN STANDARD
EN ISO 9360-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN ISO 9360-2:2002
English Version
Anaesthetic and respiratory equipment - Heat and moisture
exchangers (HMEs) for humidifying respired gases in humans -
Part 2: HMEs for use with tracheostomized patients having
minimum tidal volumes of 250 ml (ISO 9360-2:2001)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Wärme- und
Échangeurs de chaleur et d'humidité (ECH) utilisés pour Feuchtigkeitsaustauscher zur Anfeuchtung von Atemgasen
humidifier les gaz respirés par les êtres humains - Partie 2: beim Menschen - Teil 2: Wärme- und
ECH pour utilisation avec des patients trachéotomisés Feuchtigkeitsaustauscher zur Verwendung bei
ayant des volumes courants d'au moins 250 ml (ISO 9360- tracheostomierten Patienten mit Mindesthubvolumina von
2:2001) 250 ml (ISO 9360-2:2001)
This European Standard was approved by CEN on 28 March 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 9360-2:2009: E
worldwide for CEN national Members.
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SIST EN ISO 9360-2:2009
EN ISO 9360-2:2009 (E)
Contents Page
Foreword .3
Annex ZA (Informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
2
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SIST EN ISO 9360-2:2009
EN ISO 9360-2:2009 (E)
Foreword
The text of ISO 9360-2:2001 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 9360-2:2009 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 October 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 9360-2:2002.
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.
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 9360-2:2001 has been approved by CEN as a EN ISO 9360-2:2009 without any modification.
3
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SIST EN ISO 9360-2:2009
EN ISO 9360-2:2009 (E)
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.1 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.1 – Correspondence between this European Standard and EU Directives
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying
EN Directive 93/42/EEC remarks/Notes
4 13.2
5 7.5 (1st paragraph) This relevant Essential
Requirement is not fully
addressed in this European
Standard
5.1 9.1, 13.6 c)
5.2 9.1, 13.6 c)
5.3 8.3
5, 7 1 (2nd paragraph, 1st dash) This relevant Essential
Requirement is not fully
addressed in this European
Standard
5,7 1 (2nd paragraph, 2nd dash) This relevant Essential
Requirement is not fully
addressed in this European
Standard
- 6a This relevant Essential
Requirement is not
addressed in this European
Standard
7.1 a) 9.1, 13.2, 13.3 k), 13.6 c)
7.1 b) 9.1, 13.2, 13.3 j)
7.2 13.1
7.2 7.5 (2nd paragraph) This relevant Essential
Requirement is not
addressed in this European
Standard
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SIST EN ISO 9360-2:2009
EN ISO 9360-2:2009 (E)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying
EN Directive 93/42/EEC remarks/Notes
7.2 13.3 (a): This relevant Essential
Requirement is not fully
addressed in this European
Standard
7.2 a) 13.3 a)
7.2 b) 13.3 b)
7.2 c) 8.7, 13.3 c)
7.2 d) 13.3 i)
7.2 e) 13.3 l)
7.2 f) 13.3 e)
7.3 13.3 f)
7.3 13.3 (f) This relevant Essential
Requirement is not fully
addressed in this European
Standard
7.4 13.1
7.4 7.5 (3rd paragraph) This relevant Essential
Requirement is not
addressed in this European
Standard
7.4 13.6 (h)(2nd paragraph) This relevant Essential
Requirement is not fully
addressed in this European
Standard
7.4 13.6 (q) This relevant Essential
Requirement is not
addressed in this European
Standard
7.4 a) 13.1, 13.6 a), 13.6 b)
7.4 b) 9.1, 13.3 j)
7.4 d) 13.6 b)
7.4 f) 13.3 m), 13.6 h)
7.4 g) 13.3 j), 13.3 k)
7.4 k) 13.6 n)
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.
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SIST EN ISO 9360-2:2009
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SIST EN ISO 9360-2:2009
INTERNATIONAL ISO
STANDARD 9360-2
First edition
2001-04-15
Anaesthetic and respiratory equipment —
Heat and moisture exchangers (HMEs) for
humidifying respired gases in humans
Part 2:
HMEs for use with tracheostomized
patients having minimum tidal volumes of
250 ml
Matériel d'anesthésie et de réanimation respiratoire — Échangeurs de
chaleur et d'humidité (ECH) utilisés pour humidifier les gaz respirés par les
êtres humains
Partie 2: ECH pour utilisation avec des patients trachéotomisés ayant des
volumes courants d'au moins 250 ml
Reference number
ISO 9360-2:2001(E)
©
ISO 2001
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SIST EN ISO 9360-2:2009
ISO 9360-2:2001(E)
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ii © ISO 2001 – All rights reserved
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SIST EN ISO 9360-2:2009
ISO 9360-2:2001(E)
Contents Page
Foreword.iv
1 Scope .1
2 Normative references .1
3 Terms and definitions .1
4 Symbols and abbreviated terms.2
5 General requirements and recommendations .2
6 Test methods.2
7 Marking, labelling and packaging .6
Annex A (informative) Rationale .7
© ISO 2001 – All rights reserved iii
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SIST EN ISO 9360-2:2009
ISO 9360-2:2001(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.
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 9360 may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 9360-2 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 3, Lung ventilators and related equipment.
This first edition of ISO 9360-2 cancels and replaces, in part, the first edition of ISO 9360 (ISO 9360:1992), which
has been technically revised.
ISO 9360 consists of the following parts, under the general title Anaesthetic and respiratory equipment — Heat and
moisture exchangers (HMEs) for humidifying respired gases in humans:
� Part 1: HMEs for use with minimum tidal volumes of 250 ml
� Part 2: HMEs for use w
...