SIST EN ISO 9360-2:2003

SLOVENSKI STANDARD
SIST EN ISO 9360-2:2003
01-marec-2003
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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 - Echangeurs de chaleur et
d'humidité (ECH) utilisés pour humidifier les gaz respirés par les etres 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 9360-2:2002
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 9360-2:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 9360-2:2003

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SIST EN ISO 9360-2:2003
EUROPEAN STANDARD
EN ISO 9360-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2002
ICS 11.040.10
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
Echangeurs 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 23 September 2002.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, 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
© 2002 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9360-2:2002 E
worldwide for CEN national Members.

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SIST EN ISO 9360-2:2003
EN ISO 9360-2:2002 (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 9360-2:2002 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 May 2003, and conflicting national
standards shall be withdrawn at the latest by May 2003.
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 EU Directive(s).
For relationship with EU Directive(s), see informative annex ZB, 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,
Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,
Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the
United Kingdom.
Endorsement notice
The text of ISO 9360-2:2001 has been approved by CEN as EN ISO 9360-2:2002 without any
modifications.
NOTE  Normative references to International Standards are listed in Annex ZA (normative).
2

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SIST EN ISO 9360-2:2003
EN ISO 9360-2:2002 (E)
Annex ZA
(normative)
Normative references to international publications with their relevant
European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions
of any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated by
(mod.), the relevant EN/HD applies.
Publication Year Title EN/HD Year
ISO 4135 2001 Anaesthetic and respiratory equipment – EN ISO 4135 2001
Vocabulary
ISO 9360-1 2000 Anaesthetic and respiratory equipment - EN ISO 9360-1 2000
Heat and moisture exchangers (HMEs) for
humidifying respired gases in humans -
Part 1: HMEs for use with minimum tidal
volumes of 250 ml
3

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SIST EN ISO 9360-2:2003
EN ISO 9360-2:2002 (E)
Annex ZB
(informative)
Clauses of this European Standard addressing essential requirements
or other provisions of EU Directives.
This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association and supports essential requirements
of EU Directive 93/42/EEC.
WARNING: Other requirements and other EU Directives may be applicable to the product(s)
falling within the scope of this standard.
The following clauses of this standard, as given in Table ZB.1, are likely to support
requirements of Directive 93/42/EEC.
Compliance with the clauses of this standard provides one means of conforming with the
specific essential requirements of the Directive concerned and associated EFTA regulations.
Table ZB.1 – Correspondence between this European Standard and EU
Directives
Clause/subclause of this Corresponding essential Comments
European Standard requirements of Directive
93/42/EEC
413.2
5.1 9.1, 13.6 c)
5.2 9.1, 13.6 c)
5.3 8.3
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 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)
7.4 13.1
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)
4

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SIST EN ISO 9360-2:2003
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 9360-2:2003
ISO 9360-2:2001(E)
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ii © ISO 2001 – All rights reserved

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SIST EN ISO 9360-2:2003
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 9360-2:2003
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 with tracheostomized patients having minimum tidal volumes of 250 ml
Annex A of this part of ISO 9360 is for information only.
Clauses and subclauses to which there is a rationale are marked with (R). These rationales are found in annex A.
iv © ISO 2001 – All rights reserved

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SIST EN ISO 9360-2:2003
INTERNATIONAL STANDARD ISO 9360-2:2001(E)
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
1 Scope
This part of ISO 9360 is based on ISO 9360-1:2000 and specifies certain requirements and te
...