prEN ISO 9360-1

• Status: Not Published
• Publication Date: 12-Mar-2028
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 4 - Tracheal tubes and other equipment
• Current Stage: 4020 - Submission to enquiry - Enquiry
• Start Date: 20-Aug-2026
• Completion Date: 20-Aug-2026
• Ref Project: oSIST prEN ISO 9360-1:2026 - Heat and moisture exchangers, and breathing system filters for respired gases - Part 1: Common requirements (ISO/DIS 9360-1:2026)

• Revises: 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: 19-Feb-2025

Overview

prEN ISO 9360-1:2026 defines the common requirements for heat and moisture exchangers (HME), breathing system filters (BSF), and combined devices (HMEF) used with respired gases in anaesthetic and respiratory care. This international standard, developed by CEN with ISO/TC 121/SC 2, establishes guidelines for design, materials, performance, device marking, and information supplied by the manufacturer, ensuring consistent safety and efficacy in patient respiratory support systems.

The standard applies to HMEs, BSFs, and HMEFs intended for anaesthetic equipment and ventilator breathing circuits, as well as devices without a machine port. It does not cover filters for vacuum sources, gas sampling lines, compressed gases, resuscitation bag inlets, or nebuliser ports. Requirements for active HMEs are provided in ISO 80601-2-74.

Key Topics

• Device Types: HME, BSF, and combined HMEF
• Materials and Design: Specifications for housings, connectors, and internal volumes ensuring visibility and compatibility
• Performance Requirements:
  • Moisture Loss: Measurement methods referenced from ISO 9360-2
  • Filtration Performance: Methods from ISO 9360-3 for filters and combined devices
  • Resistance to Flow: Test procedures for neonate, paediatric, and adult applications
  • Gas Leakage and Compliance: Testing for integrity and flexibility under pressure
• Marking and Identification:
  • Colour coding: Blue/green for HME/HMEF, yellow/orange/red for BSF
  • Clear labelling of device function (e.g., HME, FILTER, HME+F)
• User Information:
  • Detailed instructions for use, recommended tidal volumes, flow rates, resistance levels, internal volumes, compliance, and compatibility
  • Critical safety warnings about misuse and connections

Applications

prEN ISO 9360-1 is essential for:

• Medical Device Manufacturers: Ensuring design and production of respiratory filters and heat and moisture exchangers comply with international safety and performance criteria.
• Healthcare Providers and Clinical Settings: Supporting safe selection, implementation, and maintenance of HMEs, BSFs, and HMEFs in anaesthesia and critical care ventilation systems.
• Regulatory Compliance: Providing requirements referenced in national regulations, hospital protocols, and procurement specifications for respiratory equipment.
• Risk Management: Reducing the risk of device misconnection or improper humidification, which can affect patient outcomes and safety.

Specific scenarios include use:

• Between a patient’s artificial airway (tracheal or tracheostomy tube) and anaesthesia or ventilator circuits
• Within breathing systems for reduction of airborne pathogens and particulate transmission
• In devices combining both humidifying and filtering functions for versatile respiratory care

Related Standards

• ISO 18190: General requirements for airway devices and related anaesthetic and respiratory equipment
• ISO 5356-1: Conical connectors for anaesthetic and respiratory devices
• ISO 80369-2 & ISO 80369-7: Small-bore connectors in healthcare applications
• IEC 60601-1: Medical electrical safety and essential performance
• ISO 9360-2: Methods for measuring moisture loss in HMEs and HMEFs
• ISO 9360-3: Methods for measuring filtration performance in BSFs and HMEFs
• ISO/TS 24172: Alternative test methods for heat and moisture exchangers
• ISO 80601-2-74: Requirements for active HMEs

Adhering to prEN ISO 9360-1 ensures that heat and moisture exchangers and filters in respiratory systems provide consistent protection, humidification, and filtration, ultimately safeguarding both patients and healthcare personnel. Manufacturers and clinical users benefit from clear, harmonized expectations for product performance, device identification, and safe use in critical care environments.

SLOVENSKI STANDARD
01-oktober-2026
Izmenjevalniki toplote in vlage ter filtri dihalnih sistemov za dihalne pline - 1. del:
Splošne zahteve (ISO/DIS 9360-1:2026)
Heat and moisture exchangers, and breathing system filters for respired gases - Part 1:
Common requirements (ISO/DIS 9360-1:2026)
Anästhesie- und Beatmungsgeräte - Wärme- und Feuchtigkeitsaustauscher und
Atemschutzfilter (HMEF) zur Anfeuchtung von Atemgasen beim Menschen - Teil 1:
Allgemeine Anforderungen (ISO/DIS 9360-1:2026)
Titre manque — Partie 1: Titre manque
Ta slovenski standard je istoveten z: prEN ISO 9360-1
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.

DRAFT
International
Standard
ISO/DIS 9360-1
ISO/TC 121/SC 2
Heat and moisture exchangers, and
Secretariat: ANSI
breathing system filters for respired
Voting begins on:
gases —
2026-08-20
Part 1:
Voting terminates on:
2026-11-12
Common requirements
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 9360-1:2026(en)
DRAFT
ISO/DIS 9360-1:2026(en)
International
Standard
ISO/DIS 9360-1
ISO/TC 121/SC 2
Heat and moisture exchangers, and
Secretariat: ANSI
breathing system filters for respired
Voting begins on:
gases —
2026-08-20
Part 1:
Voting terminates on:
2026-11-12
Common requirements
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2026
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 9360-1:2026(en)
ii
ISO/DIS 9360-1:2026(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 4
4.1 General .4
4.2 Ambient conditions of test .4
5 Materials . 4
5.1 General .4
5.2 Housing.4
6 Design Requirements. 6
6.1 General .6
6.2 Identification of the device .6
6.2.1 Colours . .6
6.3 Device connections .6
6.3.1 Connection ports .6
6.3.2 HMEs/HMEFs with no machine port .7
6.3.3 Accessory port .7
6.3.4 Supplementary Oxygen connection .8
6.4 Performance Requirements .8
6.4.1 General .8
6.4.2 Measurement of moisture loss .8
6.4.3 Measurement of filtration performance.8
6.4.4 Measurement of resistance to flow .8
6.4.5 Measurement of gas leakage .11
6.4.6 Measurement of compliance .11
7 Cleaning, disinfection and sterilization .11
8 Information to be supplied by the manufacturer .11
8.1 Marking on the device .11
8.2 Labelling on the packaging . 12
8.3 Instructions for use . 12
Annex A (informative) Rationale . 14
Annex B (informative) Test method for assessing visibility/legibility .16
Bibliography . 17

iii
ISO/DIS 9360-1:2026(en)
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.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
ISO 9360-1 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 2, Airway devices and related equipment.
ISO 9360 consists of the following parts, under the general title Breathing system filters for anaesthetic and
respiratory use:
— Part 1: Common requirements
— Part 2: Measurement of moisture loss
— Part 3: Measurement of filtration performance
These parts technically revise and replace ISO 9360-1:2000, ISO 9360-2:2001, ISO 23328-1:2008 and
ISO 23328-2:2009.
These parts are a combination of the above standards with new and modified requirements, in particular:
— Part 1 combines requirements from ISO 9360-1:2000 and ISO 23328-2:2009
— Part 2 combines requirements from ISO 9360-1:2000 and ISO 9360-2:2001.
— Part 3 are requirements from ISO 23328-1:2008.
Specific changes include:
— layout now follows the format of ISO 18190:202x; and references clauses from ISO 18190
— Colour coding requirements were added to distinguish between HMEs and BSFs

iv
ISO/DIS 9360-1:2026(en)
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 (HME) are used to raise the water content
and the temperature of the gas delivered to the respiratory tract of spontaneously and non-spontaneously
breathing patients. HMEs are intended to form part of a ventilator breathing system. HMEs are primarily
placed between the patient interface (e.g. Tracheal or Tracheostomy Tube) and the anaesthesia or ventilator
breathing set. HMEs are also intended for use with tracheostomy tube where the HME is not designed to
connected to a anaesthesia or ventilator breathing set.
Breathing system filters (BSF) are used to reduce particulates, including microorganisms, in gases delivered
to and exhaled from patients. BSFs are intended to form part of a ventilator breathing system. BSFs may
be placed between the patient interface and the anaesthesia or ventilator breathing set or placed between
the anaesthesia or ventilator breathing set and the anaesthesia or ventilator machine. BSF are exposed to
various levels of humidity during clinical use.
Many devices combine the characteristics of both an HME and a BSF in one combined device, called an HMEF.
HMEs and HMEFs are only intended for use between the patient interface and the anaesthesia or ventilator
breathing set.
v
DRAFT International Standard ISO/DIS 9360-1:2026(en)
Heat and moisture exchangers, and breathing system filters
for respired gases —
Part 1:
Common requirements
1 Scope
This document specifies the common requirements for heat and moisture exchangers (HME), breathing
system filters (BSF) and combined devices (HMEF) intended for anaesthetic and respiratory use. It addresses
materials, design, performance, requirements for devices supplied sterile, marking, and information to be
provided by the manufacturer.
NOTE 1 Wherever the term “device” is used in this document, it refers to an HME or, HMEF or BSF.
This document also applies to HMEs or HMEFs that do not have a machine port for connecting to a ventilator.
[1]
Requirements for active HMEs are located in ISO 80601-2-74 .
This document is not applicable to other types of filters:
— those designed to protect vacuum sources or gas sample lines;
— to filter compressed gases;
— to protect test equipment for physiological respiratory measurements;
— on inlet of resuscitation bags;
— port of nebulisers.
NOTE 2 A method for assessing moisture loss from an HME/HMEF is given in ISO 9360-2: 202X.
NOTE 3 A method for assessing filtration performance of BSF/HMEF is given in ISO 9360-3:202X.
Filters used for filtering anaesthetic gases from the respiratory gas are not within scope of this document.
[1]
NOTE 4 Requirements for Active HMEs are included in ISO 80601-2-74 .
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 18190:2025, Anaesthetic and respiratory equipment — General requirements for airway devices and related
equipment
ISO 80369-2, Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors for
respiratory applications
ISO/DIS 9360-1:2026(en)
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for
intravascular or hypodermic applications
IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020 Medical electrical equipment — Part 1: General requirements
for basic safety and essential performance
ISO 9360-2: 202X Heat and moisture exchangers, and breathing system filters for respired gases — Part 2:
Measurement of moisture loss
ISO 9360-3: 202X Heat and moisture exchangers, and breathing system filters for respired gases — Part 3:
Measurement of filtration performance
ISO TS 24172 Alternative test method for heat and moisture exchangers
3 Terms and definitions
[2]
For the purposes of this part of ISO 9360, the terms and definitions given in ISO 4135:2022 and the
following apply.
3.1
accessory port
port of the device intended for connection to an accessory
EXAMPLE Connection to a respiratory gas monitor.
3.2
active HME
device where water, water vapour or heat is actively added to the HME to increase the humidity level of the
gas delivered from the HME to the patient
[2]
[SOURCE: ISO 4135:2022 , 3.7.2.3]
3.3
breathing set
assembly of breathing tubes, connectors and components that form the inspiratory and expiratory limbs of
the gas pathways of an anaesthetic breathing system or ventilator breathing system between the ventilator
and the patient's airway device
[2]
[SOURCE: ISO 4135:2022 , 3.6.1.6]
3.4
breathing system filter
BSF
device intended to reduce transmission of airborne particulates, including microorganisms, in breathing
systems
Note 1 to entry: A BSF may be incorporated into an HME.
[2]
[SOURCE: ISO 4135:2022 , 3.6.1.5]
3.5
compliance
change in volume of gas per unit pressure change within an enclosed space
Note 1 to entry: It is deprecated to include the measurement conditions into the definition of compliance; in general
compliance may be expressed at any specified measurement condition.
[3]
Note 2 to entry: ISO 19223 provides definitions for pulmonary compliance, respiratory system compliance, static
compliance and dynamic compliance, all of which relate to the patient. Various other standards from ISO/TC 121
reference compliance with respect to items of equipment such as breathing tubes and reservoir bags.
[2]
[SOURCE: ISO 4135:2022 , 3.1.1.12]

ISO/DIS 9360-1:2026(en)
3.6
Heat and moisture exchanger, noun
HME, noun
device intended to retain a portion of the patient’s expired moisture and heat, and return it to the patient's
respiratory tract during inspiration
[2]
[SOURCE: ISO 4135:2022 , 3.7.4.1]
3.7
HMEF, FHME, noun
heat and moisture exchanger that incorporates the function of a breathing system filter
[2]
[SOURCE: ISO 4135:2022 , 3.7.4.1, deleted note]
3.8
internal volume, noun
compressible volume contained within the device
Note 1 to entry: The internal volume is intended to refer to the compressible volume occupied by breathing gases.
Note 2 to entry: The internal volume is bounded by the internal surfaces of the impermeable material of the device, the
ports of the device and excludes the internal volume of socket gas connectors.
Note 3 to entry: The internal volume excludes the volume of solid elements within the device, such as exchange media.
3.9
machine port
port of the device which is intended for connection to a patient connection port of a breathing set
3.10
moisture loss, noun
total amount of water lost from the test apparatus when tested as specified in ISO 9360-2: 202X
Note 1 to entry: It is expressed in milligrams water per litre of air.
3.11
patient connection port
port of a breathing system intended for connection to an airway device
Note 1 to entry: The patient-connection port is the en
...