EN ISO 9360-1:2000

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)

Specifies performance and test methods for HME for use principally in anaesthetic breathing systems for adults

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)

Dieser Teil von ISO 9360 legt bestimmte Anforderungen an Wärme- und Feuchtigkeitsaustauscher (HME von engl. Heat and Moisture Exchanger) fest, die für die Anfeuchtung von Atemgasen, in erster Linie von Patienten mit einem Hubvolumen von gleicher oder größer als 250 ml, verwendet werden, und die mindestens über eine Maschinenöffnung verfügen. Sie umfaßt auch HMEs mit eingebauten Atemsystemfiltern und beschreibt Prüfverfahren für ihre Beurteilung.

Matériel d'anesthésie et de réanimation respiratoire - Echangeurs 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)

L’IEC 62282-5-100:2018 couvre les exigences de construction, de marquage et d'essai des systèmes à piles à combustible portables. Ces systèmes à piles à combustible sont mobiles et ne sont ni attachés ni fixés par un autre moyen à un emplacement spécifique. Un système à pile à combustible portable est destiné à produire une puissance électrique. Le présent document s'applique aux systèmes à piles à combustible portables à courant alternatif et à courant continu dont la tension de sortie assignée ne dépasse pas 600 V en courant alternatif ou 850 V en courant continu et qui sont destinés à un usage à l'intérieur et à l'extérieur.

Anestezijska in dihalna oprema - Izmenjevalniki toplote in vlage (HMEs) za navlaževanje dihalnih plinov v človeku - 1. del: HMEs za uporabo z najmanjšo dihalno prostornino 250 ml (ISO 9360-1:2000)

General Information

• Status: Withdrawn
• Publication Date: 14-Mar-2000
• Withdrawal Date: 21-Apr-2009
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 2 - Lung ventilators
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 22-Apr-2009
• Completion Date: 22-Apr-2009
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic 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 9360-1:2000 - 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)

Relations

• Replaced By: EN ISO 9360-1:2009 - 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)
• Effective Date: 06-May-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 9360-1:2000
01-november-2000
$QHVWH]LMVNDLQGLKDOQDRSUHPD,]PHQMHYDOQLNLWRSORWHLQYODJH+0(V]D
QDYODåHYDQMHGLKDOQLKSOLQRYYþORYHNXGHO+0(V]DXSRUDER]QDMPDQMãR
GLKDOQRSURVWRUQLQRPO,62
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 - Echangeurs de chaleur et
d'humidité (ECH) utilisés pour humidifier les gaz respirés par les etres 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 9360-1:2000
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 9360-1:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

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

---------------------- Page: 2 ----------------------

ISO 9360-1:2000(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not
be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this
file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this
area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters
were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event
that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2000
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic
or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body
in the country of the requester.
ISO copyright office
Case postale 56 � CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 734 10 79
E-mail [e-mail]
Web www.iso.ch
Printed in Switzerland
ii © ISO 2000 – All rights reserved

---------------------- Page: 3 ----------------------

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 2000 – All rights reserved iii

---------------------- Page: 4 ----------------------

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

---------------------- Page: 5 ----------------------

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.
© ISO 2000 – All rights reserved v

---------------------- Page: 6 ----------------------

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 2000 – All rights reserved 1

---------------------- Page: 7 ----------------------

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 Inspiratory:expiratory ratio –
RH Relative humidity %
5 General requirements and recommendations
5.1 HME patient port connector
The connector at the patient port shall be either a 15 mm female conical connector or a 15 mm female/22 mm male
coaxial connector complying with ISO 5356-1.
5.2 Additional ports
The connectors at other ports intended to accept breathing attachments, for example a Y-piece, if present, shall be
15 mm male and/or 22 mm conical connectors as specified in ISO 5356-1.
2 © ISO 2000 – All rights reserved

---------------------- Page: 8 ----------------------

ISO 9360-1:2000(E)
If the HME incorporates an accessory port, that port shall not accept the 15 mm or 22 mm connectors specified in
ISO 5356-1 or ISO 5356-2.
5.3 Packaging of sterile HME
HME supplied sterile shall comply with the requirements specified in ISO 11607.
6 Test methods
6.1 General
The apparatus and test methods specified in 6.2 to 6.5 are not intended to exclude the use of other measuring
devices or methods yielding results of an accuracy equal to or greater than those specified. In the case of a
dispute, the methods given in this part of ISO 9360 shall be the reference methods.
The tests shall be performed at a temperature of 23 �C � 2 �C, a RH of 50 % � 20 %, and an atmospheric pressure
of 86 kPa to 106 kPa.
6.2 Measurement of moisture loss
6.2.1 Principle
The performance of an HME shall be measured by recording the mass of water lost from the test apparatus
specified in 6.2.2.
6.2.2 Test apparatus
The test apparatus (Figure 1) shall comprise the following components.
6.2.2.1 Bidirectional flow generator.
This is a mechanically-driven piston used to produce a flow having sinusoidal waveform.
6.2.2.2 Humidity generator (HG), consisting of
a) a heated water bath (Figure 2) through which air is bubbled in both directions;
b) a rigid cylindrical reservoir (Figure 3) with a maximum volume of 7 l and a diameter of approximately 150 mm,
containing a 2 l reservoir bag;
c) a thermally insulated chamber (Figure 4), which contains the water bath, the reservoir and a heat source.
6.2.2.3 Air delivery system (Figure 5), consisting of a T-piece with an internal diameter greater than 15 mm,
and an exhaust tube at least 200 mm in length.
6.2.2.4 Weighing equipment, withanaccuracyof � 0,1 g or better in the range of the mass to be measured.
6.2.2.5 Flowrate measuring equipment, with an accuracy of at least 5 % of the reading.
6.2.2.6 Calibration HME (Figure 6) consisting of a housing containing 81 polyvinyl chloride (PVC) tubes
arranged in a 9 � 9 array, each with an internal diameter of 2 mm, an external diameter of 4 mm, and a length of
50 mm.
When the apparatus has been constructed and operated as specified in 6.2.2, the moisture loss from the humidity
generator with the calibration HME will be as shown in Table 3.
© ISO 2000 – All rights reserved 3

---------------------- Page: 9 ----------------------

ISO 9360-1:2000(E)
Key
1 to 19 see annex A
20 Sinewave generator inlet
21 Air outlet
22 Dry air supply (23 � 1) °C, �1mgH O per litre air
2
23 Weighing equipment
Figure 1 — Test apparatus side view
4 © ISO 2000 – All rights reserved

---------------------- Page: 10 ----------------------

ISO 9360-1:2000(E)
Dimensions in millimetres
2 a) Heated water bath — Front view 2 b) Heated water bath — Side view
2 c) Cover of heated water bath
© ISO 2000 – All rights reserved 5

---------------------- Page: 11 ----------------------

ISO 9360-1:2000(E)
Dimensions in millimetres
2 d) Heated water bath dividing plate
Key
1 to 19 see annex A 22 Highest water level 25 Tracheal tube
20 Tracheal tube inlet 23 Lowest water level 26 Bag hole
21 Rubber bag inlet 24 Heater hole 27 Temperature sensor hole
Figure 2 — Water bath (at 37 °C)
6 © ISO 2000 – All rights reserved

---------------------- Page: 12 ----------------------

ISO 9360-1:2000(E)
Dimensions in millimetres
Ke
...