oSIST prEN ISO 9360-1:2026
(Main)Heat and moisture exchangers, and breathing system filters for respired gases - Part 1: Common requirements (ISO/DIS 9360-1:2026)
- Status
- Not Published
- Public Enquiry End Date
- 30-Oct-2026
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 4020 - Public enquire (PE) (Adopted Project)
- Start Date
- 04-Sep-2026
- Due Date
- 22-Jan-2027
oSIST prEN ISO 9360-1:2026 is the Slovenian draft standard based on ISO/DIS 9360-1:2026, published by SIST. It specifies common requirements for heat and moisture exchangers (HME), breathing system filters (BSF), and combined HMEF devices for anaesthetic and respiratory use. Manufacturers, test laboratories, and clinical users use it to select connectors, verify performance, and mark the device clearly.
What does oSIST prEN ISO 9360-1:2026 specify?
oSIST prEN ISO 9360-1:2026 specifies the common requirements for HME, BSF and HMEF devices intended for anaesthetic and respiratory use. It covers materials, design, performance, devices supplied sterile, marking, and information to be supplied by the manufacturer.
The document applies to devices with or without a machine port for connection to a ventilator. It excludes filters for vacuum sources, gas sample lines, compressed gases, physiological respiratory test equipment, resuscitation bag inlets, nebuliser ports, and filters used to filter anaesthetic gases from respiratory gas.
The document is organized into clauses on scope, normative references, terms and definitions, general requirements, materials, design requirements, cleaning/disinfection/sterilization, and manufacturer information. It also includes two informative annexes.
| Annex | What it covers |
|---|---|
| Annex A | Rationale for selected requirements, especially housing visibility, colour coding and marking |
| Annex B | Test method for assessing visibility or legibility of markings |
What are the key requirements of oSIST prEN ISO 9360-1:2026?
oSIST prEN ISO 9360-1:2026 uses ISO 18190:2025 as the general baseline for several core clauses, so many general airway-device requirements come from that related standard. In practice, that means this part adds the HME, BSF and HMEF-specific points rather than redefining every general safety rule.
Test conditions and material-related requirements
Clause 4.2 sets the ambient conditions for testing. The tests are done under defined temperature, humidity and pressure conditions, so results are comparable between laboratories.
Clause 5 applies the material requirements of ISO 18190:2025, and Clause 5.2 adds a housing-specific visibility rule. For devices with a machine port intended for mechanical ventilation, liquid water and secretions shall be visible in the housing. This matters because condensate can change pressure drop, reduce humidification performance, and create a risk of inhaled water.
Identification and connector design
Clause 6.2.1 uses colour coding to distinguish device types. BSF housings or markings use yellow, orange or red, while HME and HMEF housings or markings use blue or green. The colour must remain visible in use, which helps clinical users avoid placing the wrong device in a breathing circuit.
Clause 6.3 requires conical connection ports that conform to ISO 5356-1, with port configurations defined for the patient side and the machine side. For HME and HMEF without a machine port, the patient connection port is a 15 mm conical socket. This matters because connector compatibility is a primary control against misconnections.
Accessory and oxygen connections
Clause 6.3.3 covers accessory ports, when provided. An accessory port has to be compatible with a Luer lock connector conforming to ISO 80369-7, have a tethered sealing cap or equivalent retention feature, and carry a warning about the hazard of inadvertent Luer connections. In practice, this is aimed at common sampling ports and reduces the risk of connecting the wrong line.
Clause 6.3.4 covers supplementary oxygen connections on HME or HMEF devices without a machine port for spontaneously breathing patients. Such a connection shall either conform to the R2 socket connector of ISO 80369-2 or have a permanently connected oxygen tube. This helps control how oxygen is added to the breathing path.
Performance tests
Clause 6.4.2 requires moisture loss to be measured by the method in ISO 9360-2. Clause 6.4.3 requires filtration performance for BSF and HMEF to be measured by the method in ISO 9360-3. Clause 6.4.4, 6.4.5 and 6.4.6 cover resistance to flow, gas leakage and compliance.
These tests matter because they describe how the device behaves in a breathing system:
- resistance to flow is checked at flowrates for neonatal, paediatric and adult intended use
- gas leakage is limited and measured under internal pressure
- compliance is measured from the change in volume under pressure
The same resistance, leakage and compliance tests are repeated after preconditioning for the recommended maximum time of use, so the device is assessed in a more realistic in-use condition.
Marking, packaging and instructions for use
Clause 8 requires the manufacturer to provide device marking, packaging labelling and instructions for use in line with ISO 18190. The device marking identifies orientation, uses the correct colour coding where applicable, and shows the device type as BSF, HME or HMEF. The packaging label also has to identify the device clearly.
The instructions for use must give the recommended range of tidal volumes and/or flowrates, measured resistance to flow, internal volume, gas leakage, compliance, and, for HME/HMEF, moisture loss. For BSF/HMEF, the instructions also include penetration information, plus warnings about using a BSF in place of an HME, using small-bore connectors, and using nebulizers, inhaled medications or humidifiers when relevant. That information helps buyers, clinicians and trainers match the device to the intended breathing circuit.
What terms does oSIST prEN ISO 9360-1:2026 define?
- Heat and moisture exchanger (HME) - a device that retains some expired heat and moisture and returns them to the patient during inspiration.
- Breathing system filter (BSF) - a device intended to reduce airborne particulates, including microorganisms, in breathing systems.
- HMEF - a heat and moisture exchanger that also incorporates the function of a breathing system filter.
- Active HME - an HME in which water, water vapour or heat is actively added to increase gas humidity.
- Machine port - the port intended for connection to a patient connection port of a breathing set.
- Patient connection port - the port of the breathing system intended for connection to an airway device such as a tracheal tube, tracheostomy tube, face mask or supra-laryngeal airway.
- Internal volume - the compressible volume contained within the device and occupied by breathing gases.
- Pressure drop - the difference between upstream and downstream pressure at a specified constant gas flowrate through the device.
Who uses oSIST prEN ISO 9360-1:2026?
Manufacturers of anaesthetic and respiratory equipment use oSIST prEN ISO 9360-1:2026 to design the housing, ports, markings and performance claims for HME, BSF and HMEF devices. Test laboratories use it to run the moisture loss, filtration, resistance, leakage, compliance and legibility checks.
Clinical engineers, respiratory teams, anaesthesia teams and buyers use it to distinguish the right device type for a breathing circuit and to check compatibility with connectors and accessories. It is especially relevant in hospitals and other healthcare settings that use ventilator breathing systems and anaesthetic breathing systems.
What changed in oSIST prEN ISO 9360-1:2026 from the previous edition?
The foreword says this part technically revises and replaces ISO 9360-1:2000, ISO 9360-2:2001, ISO 23328-1:2008 and ISO 23328-2:2009. It also says the series combines requirements from those earlier standards.
The stated changes include:
- the layout now follows the format of ISO 18190:2025 and uses its clause structure as a reference
- colour coding requirements were added to distinguish between HMEs and BSFs
Which standards are used with oSIST prEN ISO 9360-1:2026?
- ISO 18190:2025 - supplies the general requirements for airway devices and related equipment that this document reuses in several clauses.
- ISO 5356-1 - defines the conical connectors used for the device connection ports.
- ISO 80369-2 - supports the R2 connector option for supplementary oxygen connections.
- ISO 80369-7 - defines the Luer lock connector used for accessory ports.
- IEC 60601-1 - is referenced for the symbols and safety sign used when marking accessory ports.
- ISO 9360-2:202X - gives the method for measuring moisture loss and the preconditioning basis for several tests.
- ISO 9360-3:202X - gives the method for measuring filtration performance.
- ISO TS 24172 - provides an alternative test method for heat and moisture exchangers.
- ISO 80601-2-74 - is named in the scope for active HMEs.
- ISO 4135:2022 - supplies the terms and definitions used in Clause 3.
What does the oSIST prEN ISO 9360-1:2026 document contain?
The document contains a set of product requirements, test methods and user-information requirements for HME, BSF and HMEF devices. Its main technical content is in the tables, figures and test procedures that define connector forms, colour coding, resistance test flowrates, leakage limits and compliance measurement.
It includes a housing visibility test, connector configuration guidance, a resistance-to-flow test setup, a gas-leakage method and a compliance method. It also includes a visibility/legibility test in Annex B for checking whether markings can be read in use. For documentation and lab work, the most useful items are Table 1 on colours, Table 2 on connection ports, Table 3 on test requirements, Table 4 on flowrates, Table 5 on device labels, Figure 1 on housing transparency and Figure 3 on the resistance test arrangement.
Relations
- Effective Date
- 19-Feb-2025
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Frequently Asked Questions
oSIST prEN ISO 9360-1:2026 is a draft published by the Slovenian Institute for Standardization (SIST). Its full title is "Heat and moisture exchangers, and breathing system filters for respired gases - Part 1: Common requirements (ISO/DIS 9360-1:2026)". This standard covers: La présente partie de l'ISO 9360 spécifie certaines exigences relatives aux échangeurs de chaleur et d'humidité (ECH), y compris ceux équipés de filtres pour systèmes respiratoires, essentiellement destinés à humidifier les gaz respirés par les patients ayant un volume courant supérieur ou égal à 250 ml, et comportant au moins un orifice côté appareil, et décrit des méthodes d'essai permettant de les évaluer.
La présente partie de l'ISO 9360 spécifie certaines exigences relatives aux échangeurs de chaleur et d'humidité (ECH), y compris ceux équipés de filtres pour systèmes respiratoires, essentiellement destinés à humidifier les gaz respirés par les patients ayant un volume courant supérieur ou égal à 250 ml, et comportant au moins un orifice côté appareil, et décrit des méthodes d'essai permettant de les évaluer.
oSIST prEN ISO 9360-1:2026 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
oSIST prEN ISO 9360-1:2026 has the following relationships with other standards: It is inter standard links to SIST EN ISO 9360-1:2009. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
oSIST prEN ISO 9360-1:2026 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
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
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This document has not been edited by the ISO Central Secretariat.
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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
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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.
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related to conformity assessment, as well as information about ISO's adherence to the World Trade
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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
...