EN ISO 9360-1:2009

SLOVENSKI STANDARD
01-julij-2009
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SIST EN ISO 9360-1:2000
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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 (ISO 9360-1:2000)
Anästhesie- und Beatmungsgeräte - Wärme- und Feuchtigkeitsaustauscher zur
Anfeuchtung von Atemgasen beim Menschen - Teil 1: Wärme- und
Feuchtigkeitsaustauscher zur Verwendung bei Mindesthubvolumina von 250 ml (ISO
9360-1:2000)
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
1: ECH pour utilisation avec des volumes courants d'au moins 250 ml (ISO 9360-1:2000)
Ta slovenski standard je istoveten z: EN ISO 9360-1:2009
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 9360-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN ISO 9360-1:2000
English Version
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 (ISO
9360-1:2000)
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 1: beim Menschen - Teil 1: Wärme- und
ECH pour utilisation avec des volumes courants d'au moins Feuchtigkeitsaustauscher zur Verwendung bei
250 ml (ISO 9360-1:2000) Mindesthubvolumina von 250 ml (ISO 9360-1:2000)
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 9360-1:2009: 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 9360-1:2000 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 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 9360-1:2000.
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 9360-1:2000 has been approved by CEN as a EN ISO 9360-1:2009 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.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
- 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
5.1 9.1, 13.6 c)
5.2 9.1, 13.6 c)
5.3 8.3
5, 6, 7 1 (1st paragraph) This relevant Essential
Requirement is not fully
addressed in this European
Standard
5, 6, 7 1 (2nd paragraph, 1st dash) This relevant Essential
Requirement is not fully
addressed in this European
Standard
5, 6, 7 1 (2nd paragraph, 2nd This relevant Essential
Requirement is not fully
dash)
addressed in this European
Standard
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying
EN Directive 93/42/EEC remarks/Notes
- 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 13.3 (a): This relevant Essential
Requirement is not fully
addressed in this European
Standard
- 13.3 (f) This relevant Essential
Requirement is not
addressed in this European
Standard
- 13.6 (h)(2nd paragraph) This relevant Essential
Requirement is not
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)
7.4 13.1
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) 13.6 b)
7.4 g) 13.6 b)
7.4 h) 13.3 j), 13.3 k)
7.4 i) 13.3 m), 13.6 h)
7.4 j) 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.
INTERNATIONAL ISO
STANDARD 9360-1
First edition
2000-03-15
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
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 1: ECH pour utilisation avec des volumes courants d'au moins
250 ml
Reference number
ISO 9360-1:2000(E)
©
ISO 2000
ISO 9360-1:2000(E)
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ii © ISO 2000 – All rights reserved

ISO 9360-1:2000(E)
Contents Page
Foreword.iv
Introduction.v
1 Scope .1
2 Normative references .1
3 Terms and definitions .1
4 Symbols and abbreviated terms .2
5 General requirements and recommendations.2
5.1 HME patient port connector.2
5.2 Additional ports .2
5.3 Packaging of sterile HME.3
6 Test methods.3
6.1 General.3
6.2 Measurement of moisture loss.3
6.3 Measurement of pressure drop.13
6.4 Test for gas leakage .13
6.5 Test for compliance.13
7 Marking .15
Annex A (informative) Lists of parts and specifications in Figures 1 and 2 .17
Annex B (informative) Rationale.18
ISO 9360-1:2000(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 9360-1 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 9360-1 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
Annexes A and B of this part of ISO 9360 are for information only.
iv © ISO 2000 – All rights reserved

ISO 9360-1:2000(E)
Introduction
The gases generally available for medical use lack sufficient moisture to be physiologically acceptable to the
respiratory tract of patients. Heat and moisture exchangers are used to raise the water content and the temperature
of the gas delivered to the respiratory tract. They are primarily intended for use independently or as part of a
breathing system.
INTERNATIONAL STANDARD ISO 9360-1:2000(E)
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
1 Scope
This part of ISO 9360 specifies certain requirements for heat and moisture exchangers (HMEs), including those
incorporating breathing system filters, intended for the humidification of respired gases for use primarily with
patients with a tidal volume equal to or greater than 250 ml, and incorporating at least one machine port, and
describes test methods for their evaluation.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this part of ISO 9360. For dated references, subsequent amendments to, or revisions of, any of these publications
do not apply. However, parties to agreements based on this part of ISO 9360 are encouraged to investigate the
possibility of applying the most recent editions of the normative documents indicated below. For undated
references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain
registers of currently valid International Standards.
ISO 4135: 1995, Anaesthesiology — Vocabulary.
ISO 5356-1:1996, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets.
ISO 5356-2:1987, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-
bearing connectors.
ISO 7000:1989, Graphical symbols for use on equipment — Index and synopsis.
ISO 11607, Packaging for terminally sterilized medical devices.
IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety.
3 Terms and definitions
For the purposes of this part of ISO 9360, the terms and definitions given in ISO 4135 and the following apply.
3.1
heat and moisture exchanger
HME
device intended to retain a portion of the patient's expired moisture and heat, and return it to the respiratory tract
during inspiration
ISO 9360-1:2000(E)
3.2
HME machine port
that port of the HME which is connected to the patient connection port of a breathing system
3.3
HME patient port
that port of the HME which is connected to the patient's respiratory tract
3.4
HME accessory port
that port of the HME which can be connected to an accessory device
EXAMPLE An accessory device may be e.g. a gas sampling line.
3.5
HME internal volume
volume contained within the HME, when unpressurized, minus the volume of all solid elements within the HME,
minus the volume inside all female connectors
3.6
HME moisture loss
total amount of water lost from the test apparatus when tested as specified in 6.2
NOTE It is expressed in milligrams water per litre of air.
3.7
pressure drop
difference between the pressure measured in a gas stream flowing into a device and the pressure measured in the
gas stream flowing out of the device, with a given continuous gas flowrate through the device
4 Symbols and abbreviated terms
The principal symbols and abbreviations used in this part of ISO 9360 are given in Table 1. Other symbols and
abbreviations are explained in the relevant context.
Table 1 — Symbols and abbreviations
Symbol Term Unit
V Tidal volume ml
T
�1
f Frequency
min
I:E ratio Inspira
...