EN ISO 15002:2024

Flow control devices for connection to a medical gas supply system (ISO 15002:2023)

This document specifies requirements for flow control devices that can be connected by the user either directly, by means of a probe or a gas-specific connector, or indirectly by means of a low-pressure hose assembly conforming with ISO 5359 to:
a)    a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016;
b)    the pressure outlet of a regulator conforming with ISO 10524-1:2018; or
c)    to the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 10524-3 (see 5.2 gas inlets).
This document applies to the following types of flow control devices (FCDs):
a)    flowmeters;
b)    flowgauge FCDs; and
c)    fixed orifice FCDs.
NOTE       Flow control devices that are classed as medical electrical equipment can be subject to additional requirements of IEC 60601-1.
This document applies to flow control devices for the following gases:
—    oxygen;
—    oxygen 93 %;
—    nitrous oxide;
—    medical air;
—    carbon dioxide;
—    oxygen/nitrous oxide mixture 50/50 (% volume fraction);
—    oxygen-enriched air;
—    helium;
—    xenon; and
—    specified mixtures of the gases listed above.
NOTE Flow control devices can be available for other gases.
This document does not apply to flow control devices that are:
a)    for use with gases for driving surgical tools;
b)    an integral part of a regulator (see ISO 10524-1:2018); or
c)           an integral part of a valve with integrated pressure regulator (VIPR) (see ISO 10524-3).

Durchflussregeleinrichtungen zum Anschluss an ein Versorgungssystem für medizinische Gase (ISO 15002:2023)

1.1   Dieses Dokument legt Anforderungen an Durchflussregeleinrichtungen fest, die vom Anwender entweder direkt über einen Stecker oder ein gasartspezifisches Verbindungsstück oder indirekt über ein Niederdruck-Schlauchleitungssystem nach ISO 5359 angeschlossen werden können an:
a)   eine Entnahmestelle nach ISO 9170 1 eines Rohrleitungssystems für medizinische Gase nach ISO 7396 1:2016;
b)   den Druckausgang eines Regelgeräts nach ISO 10524 1:2018; oder
c)   den Druckausgang eines Ventils mit integriertem Druckminderer (VIPR, en: valve with integrated pressure regulator) nach ISO 10524 3 (siehe 5.2 Gaseingänge).
1.2   Dieses Dokument ist für folgende Typen von Durchflussregeleinrichtungen (FCD, en: flow control device) anwendbar:
a)   Durchflussmessgeräte;
b)   Durchflussregeleinrichtungen mit Gerät zur Messung des Durchflusses nach dem Wirkdruckverfahren; und
c)   Durchflussregeleinrichtungen mit fester Blende.
ANMERKUNG   Durchflussregeleinrichtungen, die als medizinische elektrische Geräte eingestuft sind, können den zusätzlichen Anforderungen von IEC 60601 1 unterliegen.
1.3   Dieses Dokument ist für Durchflussregeleinrichtungen für folgende Gase anwendbar:
   Sauerstoff;
   Sauerstoff 93 %;
   Distickstoffoxid (Lachgas);
   medizinische Luft;
   Kohlenstoffdioxid;
   Sauerstoff-Distickstoffoxid-Gemisch 50/50 (Volumenanteil %);
   mit Sauerstoff angereicherte Luft;
   Helium;
   Xenon; und
   festgelegte Gemische der oben genannten Gase.
ANMERKUNG   Durchflussregeleinrichtungen können für andere Gase verfügbar sein.
1.4   Dieses Dokument ist nicht abwendbar für Durchflussregeleinrichtungen, die:
a)   zur Verwendung mit Gasen für den Antrieb chirurgischer Instrumente vorgesehen sind;
b)   fester Bestandteil eines Regelgeräts sind (siehe ISO 10524 1:2018); oder
c)   fester Bestandteil eines Ventils mit integriertem Druckminderer (VIPR) sind (siehe ISO 10524 3).

Dispositifs de contrôle du débit pour raccordement à un système d'alimentation en gaz médicaux (ISO 15002:2023)

Le présent document spécifie les exigences relatives aux dispositifs de contrôle du débit qui peuvent être raccordés par l’utilisateur soit directement, à l’aide d’une sonde ou d’un raccord spécifique au gaz, soit indirectement à l’aide d’un flexible de raccordement basse pression conforme à l’ISO 5359:
a)    à une prise murale conforme à l’ISO 9170‑1 d’un système de distribution de gaz médicaux conforme à l’ISO 7396‑1:2016;
b)    à la sortie en pression d’un détendeur conforme à l’ISO 10524‑1:2018; ou
c)    à la sortie en pression d’un robinet avec détendeur intégré (VIPR) conforme à l’ISO 10524‑3 (voir 5.2 Entrées de gaz).
Le présent document s’applique aux types de dispositifs de contrôle du débit suivants:
a)    débitmètres;
b)    dispositifs de contrôle du débit à indicateur de débit; et
c)    dispositifs de contrôle du débit à orifice fixe.
NOTE       Les dispositifs de contrôle du débit qui sont classés dans la catégorie des appareils électromédicaux peuvent être soumis aux exigences supplémentaires de l’IEC 60601‑1.
Le présent document s’applique aux dispositifs de contrôle du débit pour les gaz suivants:
—    oxygène;
—    oxygène à 93 %;
—    protoxyde d’azote;
—    air médical;
—    dioxyde de carbone;
—    mélange oxygène/protoxyde d’azote 50/50 (% en volume);
—    air enrichi en oxygène;
—    hélium;
—    xénon; et
—    mélanges spécifiés de gaz répertoriés ci-dessus.
NOTE       Les dispositifs de contrôle du débit peuvent être disponibles pour d’autres gaz.
Le présent document ne s’applique pas aux dispositifs de contrôle du débit qui sont:
a)    utilisables avec des gaz moteurs pour les instruments chirurgicaux;
b)    partie intégrante d’un détendeur (voir l’ISO 10524‑1:2018); ou
c)    partie intégrante d’un robinet avec détendeur intégré (VIPR) (voir l’ISO 10524‑3).

Naprave za uravnavanje pretoka v priključitvi na sistem oskrbe z medicinskimi plini (ISO 15002:2023)

Ta dokument določa zahteve za naprave za uravnavanje pretoka, ki jih lahko uporabnik priključi bodisi neposredno, z uporabo sonde ali posebnega priključka za plin, bodisi posredno, z uporabo nizkotlačne povezovalne cevi v skladu s standardom ISO 5359 z naslednjim:
a)    s končnim delom (v skladu s standardom ISO 9170-1) napeljav za medicinske pline (v skladu s standardom ISO 7396-1:2016;)
b)    odprtino za tlak tlačnega regulatorja v skladu s standardom ISO 10524-1:2018; ali
c)    odprtino za tlak tlačnega regulatorja v sklopu ventila (VIPR) v skladu s standardom ISO 10524-3 (glej točko 5.2 – dovodni priključki za plin).
Ta dokument se uporablja za naslednje vrste naprav za uravnavanje pretoka (FCD):
a)    merilniki pretoka;
b)    naprave za uravnavanje pretoka z merilnikom pretoka; in
c)    naprave za uravnavanje pretoka s stalno obliko.
OPOMBA:       Za naprave za nadzor pretoka, ki so razvrščene kot medicinska električna oprema, lahko veljajo dodate zahteve standarda IEC 60601-1.
Ta dokument se uporablja za naprave za nadzor pretoka naslednjih plinov:
–    kisik;
–    93-odstotni kisik;
–    dušikov oksid;
–    medicinski zrak;
–    ogljikov dioksid;
–    mešanica kisika/dušikovega oksida 50/50 (% deleža prostornine);
–    s kisikom obogateni zrak;
–    helij;
–    ksenon; in
–    določene zmesi zgoraj navedenih plinov.
OPOMBA: Naprave za nadzor pretoka se lahko uporabljajo tudi za druge vrste plinov.
Ta dokument se ne uporablja za naprave za nadzor pretoka, ki:
a)    se uporabljajo s plini, ki omogočajo uporabo kirurških instrumentov;
b)    so sestavni del regulatorja tlaka (glej standard ISO 10524-1:2018); ali
c)    so sestavni del tlačnega regulatorja v sklopu ventila (VIPR) (glej standard ISO 10524-3).

General Information

• Status: Published
• Publication Date: 26-Mar-2024
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 3 - Medical gas supply systems
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 27-Mar-2024
• Completion Date: 27-Mar-2024
• Ref Project: SIST EN ISO 15002:2024 - Flow control devices for connection to a medical gas supply system (ISO 15002:2023)

Relations

• Replaces: EN ISO 15002:2008/A1:2019 - Flow-metering devices for connection to terminal units of medical gas pipeline systems - Amendment 1 (ISO 15002:2008/Amd 1:2018)
• Effective Date: 08-Apr-2024
• Replaces: EN ISO 15002:2008 - Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)
• Effective Date: 04-Oct-2023

Overview

EN ISO 15002:2024 (adoption of ISO 15002:2023) specifies requirements for flow control devices (FCDs) used with a medical gas supply system. It covers user‑connectable devices - directly, via a probe or gas‑specific connector, or indirectly using a low‑pressure hose assembly conforming to ISO 5359 - to terminal units, regulator outlets or valve‑integrated pressure regulator (VIPR) outlets. Typical FCD types in scope are flowmeters, flowgauge FCDs and fixed orifice FCDs. The standard addresses devices for gases such as oxygen (including 93%), medical air, nitrous oxide, carbon dioxide, helium, xenon and specified mixtures.

Key topics and technical requirements

• Scope and application: Defines connection methods and explicitly lists included/excluded device types (excludes FCDs integral to regulators or VIPRs, and devices for driving surgical tools).
• Design requirements: General construction, gas inlet and outlet interfaces, mechanical strength, leakage control, flow indication and accuracy expectations.
• Performance characteristics: Stability of indicated flow, continuous increase in flow, and maximum flow marking requirements so users know potential patient delivery.
• Materials and oxygen compatibility: Requirements for materials and handling of oxygen‑compatible components.
• Environmental and usability: Environmental conditions aligned with emergency equipment requirements (e.g., IEC 60601‑1‑12) and usability/risk‑management provisions.
• Testing, marking and documentation: Test methods (Annex C), required markings (including maximum achievable flow), packaging, and instructions for use. A hazard identification annex (Annex D) and rationale (Annex A) support implementation.

Practical applications

• Ensures safe and accurate delivery of prescribed gas flows to patient interfaces (nasal cannula, facemask) from hospital pipeline systems, regulators or VIPRs.
• Guides manufacturers on design, testing and labeling to meet regulatory and clinical requirements.
• Supports procurement and clinical engineering teams selecting compatible, compliant flow control devices for wards, emergency and operating rooms.

Who should use this standard

• Medical device manufacturers and product designers of flowmeters, flowgauge and fixed‑orifice FCDs
• Biomedical engineers, clinical procurement and hospital gas system managers
• Test laboratories and conformity assessment bodies
• Regulatory and quality teams preparing technical documentation and risk assessments

Related standards

• ISO 5359 (low‑pressure hose assemblies)
• ISO 9170‑1 and ISO 7396‑1 (medical gas pipeline systems and terminal units)
• ISO 10524‑1 and ISO 10524‑3 (regulators and VIPRs)
• IEC 60601‑1 (where FCDs are medical electrical equipment)

Keywords: EN ISO 15002:2024, flow control devices, medical gas supply, flowmeters, medical gas pipeline, regulator, VIPR, flow accuracy, ISO 15002.

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2024
Nadomešča:
SIST EN ISO 15002:2008/A1:2020
Naprave za uravnavanje pretoka v priključitvi na sistem oskrbe z medicinskimi
plini (ISO 15002:2023)
Flow control devices for connection to a medical gas supply system (ISO 15002:2023)
Durchflussregeleinrichtungen zum Anschluss an ein Versorgungssystem für
medizinische Gase (ISO 15002:2023)
Dispositifs de contrôle du débit pour raccordement à un système d'alimentation en gaz
médicaux (ISO 15002:2023)
Ta slovenski standard je istoveten z: EN ISO 15002:2024
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.

EN ISO 15002
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2024
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 15002:2008
English Version
Flow control devices for connection to a medical gas
supply system (ISO 15002:2023)
Dispositifs de contrôle du débit pour raccordement à Durchflussregeleinrichtungen zum Anschluss an ein
un système d'alimentation en gaz médicaux (ISO Versorgungssystem für medizinische Gase (ISO
15002:2023) 15002:2023)
This European Standard was approved by CEN on 23 March 2024.

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-CENELEC 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-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15002:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 15002:2023 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 15002:2024 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 September 2024, and conflicting national standards
shall be withdrawn at the latest by September 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 15002:2008.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
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,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 15002:2023 has been approved by CEN as EN ISO 15002:2024 without any modification.

INTERNATIONAL ISO
STANDARD 15002
Third edition
2023-08
Flow control devices for connection to
a medical gas supply system
Dispositifs de contrôle du débit pour raccordement à un système
d'alimentation en gaz médicaux
Reference number
ISO 15002:2023(E)
ISO 15002:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 15002:2023(E)
Contents Page
Foreword .iv
Introduction . vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General requirements . 3
4.1 Risk management . 3
4.2 Usability . 3
4.3 Materials . 4
4.4 Oxygen compatibility . 4
4.5 Environmental conditions . 4
5 Design requirements .5
5.1 General . 5
5.2 Gas inlets . 6
5.3 Outlet connectors . 6
5.4 Mechanical strength . 6
5.5 Leakage . 6
5.6 Flow indication . 7
5.7 Accuracy . 7
5.8 Stability of indicated flow . 8
5.9 Continuous increase in flow . 8
5.10 Security of components . 8
5.11 Flow controls and flow selectors . 8
6 Packaging. 9
7 Information supplied by the manufacturer . 9
7.1 General . 9
7.2 Marking . 9
7.3 Instructions for use . 10
Annex A (informative) Rationale .11
Annex B (informative) Examples of flow control devices and gas supply inlets .13
Annex C (normative) Test methods.15
Annex D (informative) Hazard identification for risk assessment .20
Bibliography .22
iii
ISO 15002:2023(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.
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 document 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.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 6, Medical gas supply systems.
This third edition cancels and replaces the second edition (ISO 15002:2008), which has been technically
revised. It also incorporates the Amendment ISO 15002:2008/Amd.1:2018.
The main changes are as follows:
— title changed as the requirements for flow control devices are the same regardless of the gas supply
and they control the flow, they do not measure the flow;
— layout changed from requirements for each type of flow control device to the common requirements
as they are the same for each flow control device;
— test methods have been rationalised and put into a new Annex C;
— hazard identification list added as a new Annex D;
— the maximum flow that can be achieved when the flow control is opened fully has been included
as a marking requirement on the device so that the user will know what could be delivered to the
patient. A rationale has also been added to cover this marking requirement;
— a new requirement has been added for stability of setting;
— the environmental conditions have been aligned with IEC 60601-1-12, emergency equipment, as
flow control devices are used in such environments; and
— the requirement for accuracy has been rationalised for clarity.
iv
ISO 15002:2023(E)
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html
v
ISO 15002:2023(E)
Introduction
Flow control devices are used to administer a prescribed flow of gas to a patient interface device (e.g.
nasal cannula, facemask) from a pressure gas source, such as a medical gas supply system. These devices
need to deliver accurate flows under varying conditions of temperature and inlet pressures. Therefore,
it is important that the performance characteristics be specified and tested in a defined manner.
Annex A provides additional insight into the reasoning that led to the requirements and
recommendations that have been incorporated in this document. It is considered that knowledge of the
reasons for the requirements will not only facilitate the proper application of this document but will
expedite any subsequent revisions.
vi
INTERNATIONAL STANDARD ISO 15002:2023(E)
Flow control devices for connection to a medical gas supply
system
1 Scope
1.1 This document specifies requirements for flow control devices that can be connected by the user
either directly, by means of a probe or a gas-specific connector, or indirectly by means of a low-pressure
hose assembly conforming with ISO 5359 to:
a) a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with
ISO 7396-1:2016;
b) the pressure outlet of a regulator conforming with ISO 10524-1:2018; or
c) to the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 10524-3
(see 5.2 gas inlets).
1.2 This document applies to the following types of flow control devices (FCDs):
a) flowmeters;
b) flowgauge FCDs; and
c) fixed orifice FCDs.
NOTE Flow control devices that are classed as medical electrical equipment can be subject to additional
requirements of IEC 60601-1.
1.3 This document applies to flow control devices for the following gases:
— oxygen;
— oxygen 93 %;
— nitrous oxide;
— medical air;
— carbon dioxide;
— oxygen/nitrous oxide mixture 50/50 (% volume fraction);
— oxygen-enriched air;
— helium;
— xenon; and
— specified mixtures of the gases listed above.
NOTE Flow control devices can be available for other gases.
1.4 This document does not apply to flow control devices that are:
a) for use with gases for driving surgical tools;
b) an integral part of a regulator (see ISO 10524-1:2018); or
ISO 15002:2023(E)
c) an integral part of a valve with integrated pressure regulator (VIPR) (see ISO 10524-3).
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 32, Gas cylinders for medical use — Marking for identification of content
ISO 5359, Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical
gases
ISO 7396-1:2016, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases
and vacuum
ISO 9170-1:2017, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with
compressed medical gases and vacuum
ISO 10524-1:2018, Pressure regulators for use with medical gases — Part 1: Pressure regulators and
pressure regulators with flow-metering devices
ISO 10524-3, Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with
cylinder valves (VIPRs)
ISO 15001, Anaesthetic and respiratory equipment — Compatibility with oxygen
1)
ISO 17256 , Anaesthetic and respiratory equipment — Respiratory therapy tubing and connectors
ISO 18562-1, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1:
Evaluation and testing within a risk management process
ISO 20417, Medical devices — Information to be supplied by the manufacturer
CGA V5, Diameter Index Safety System (Non-Interchangeable Low Pressure Connections for Medical Gas
Applications)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
NOTE The terms defined in Clause 3 are delineated throughout this document in italic font.
3.1
flow control device
FCD
device that indicates the selected flow of a specific gas
Note 1 to entry: Typical examples of flow control devices are given in Annex B, Figure B.1.
1) Under preparation. Stage at the time of publication: ISO/DIS 17256:2023.
ISO 15002:2023(E)
3.2
flowgauge FCD
flow control device that measures gas pressure and that is calibrated in units of flow
Note 1 to entry: Flowgauge FCDs indicate flow by measuring the pressure upstream of a fixed orifice.
3.3
flowmeter
flow control device that indicates the actual flow of gas to the patient e.g. by means of a bobbin/float
within a graduated tube, or a deflected paddle
3.4
fixed orifice FCD
flow control device with a flow selector, for selecting the flow and indicating the flow selected
3.5
gas specific
having characteristics which prevent connections between different gas services or vacuum service
[SOURCE: ISO 9170-1:2017, 3.2]
3.6
rated inlet pressure P
upstream pressure (or pressure range) for which the flow control device is designed to operate
3.7
securely attached
not detachable without the use of a tool
4 General requirements
NOTE Unless otherwise specified, pressures in this document are expressed as gauge pressures (i.e.
atmospheric pressure is defined as zero).
4.1 Risk management
This document specifies requirements that are generally applicable to hazards associated with flow
control devices. Manufacturers shall apply an established risk management process to the design of
flow control devices (e.g. ISO 14971). The risk management process should include at least the following
elements:
— risk analysis;
— risk evaluation;
— risk control; and
— production and post-production information.
NOTE See Annex D for a list of hazards that can be used as guidance in the risk management process.
Check conformance by inspection of the risk management file.
4.2 Usability
Manufacturers shall apply a usability engineering process to assess and mitigate any hazards caused by
usability problems associated with correct use (i.e. normal use) and use errors (e.g. IEC 60601-1-6 and
IEC 62366-1).
Check conformance by inspection of the usability engineering file.
ISO 15002:2023(E)
4.3 Materials
4.3.1 Materials shall be resistant to corrosion and designed to withstand the environmental
conditions specified in 4.5.
Check conformance by inspection of the technical file.
4.3.2 Materials shall be compatible with the gases with which they can come into contact.
NOTE ISO 11114-1 and ISO 11114-2 can offer helpful guidance on material compatibility with gases.
Check conformance by inspection of the technical file.
4.3.3 Materials in the breathing gas pathway shall be evaluated for biocompatibility according to
ISO 18562-1.
NOTE ISO 18562-1 also refers to other parts of the 18562 series for biocompatibility evaluation of
particulates, volatile organic compounds and leachables.
Check conformance by inspection of the technical file.
4.3.4 Materials shall be resistant to deterioration by cleaning and disinfection or sterilization
methods recommended by the manufacturer [see 7.3 h)].
Check conformance by inspection of the technical file.
4.3.5 The selection of materials shall include a systematic review of their carcinogenic, mutagenic or
toxic to reproduction (‘CMR’) or endocrine-disrupting properties.
For those materials present in excess of 0,1 % (w/w) in any parts, a safer alternative should be used.
If no suitable alternative exists, the risk for patient or user shall be assessed taking into account the
intended use and latest relevant scientific committee guidelines.
Check conformance by inspection of the technical file and the risk management file.
4.4 Oxygen compatibility
NOTE There is rationale for this subclause in A.2.
Components and lubricants used during the manufacture of flow control devices that come into contact
with medical gases during normal use shall meet the compatibility requirements of ISO 15001.
Check conformance by inspection of the technical file.
4.5 Environmental conditions
NOTE There is rationale for this subclause in A.3.
4.5.1 Transport and storage environmental conditions
4.5.1.1 Unless different environmental conditions for transport and storage are stated by the
manufacturer in their instructions for use [see 7.3 i)] flow control devices shall comply with the
performance requirements specified in Clause 5 after being exposed, whilst packed for transport and
storage, to the following environmental conditions:
a) −40 °C to +5 °C without relative humidity control;
b) >5 °C to 35 °C at a relative humidity up to 90 %, non-condensing; and
ISO 15002:2023(E)
c) >35 °C to 70 °C at a water vapour pressure up to 50 hPa.
NOTE Performance requirements include: mechanical strength (5.4); leakage (5.5); accuracy (5.7) and
stability of indicated flow (5.8)
Check conformance by the tests given in Annex C.
4.5.1.2 If manufacturers state a different range of environmental transport and storage conditions in
their instructions for use they shall:
a) justify these transport and storage environmental conditions in their risk management file;
b) mark these transport and storage environmental conditions on the packaging; and
c) comply with the performance requirements specified in Clause 5 after being exposed, whilst
packed for transport and storage, at these environmental conditions.
NOTE Performance requirements include: mechanical strength (5.4), leakage (5.5), accuracy (5.7) and
stability of indicated flow (5.8)
Check conformance by:
— inspection of the risk management file;
— visual inspection of the packaging; and
— by performing the tests given in Annex C.
4.5.2 Operating environmental conditions
4.5.2.1 Flow control devices shall comply with the performance requirements specified in Clause 5
when operated under normal environmental conditions [i.e. a temperature of (23 ± 3) °C and an
atmospheric pressure of 101,3 kPa].
NOTE Performance requirements include: mechanical strength (5.4), leakage (5.5), accuracy (5.7), stability
of indicated flow (5.8) and continuous increase in flow (5.9).
Check conformance by the tests given in Annex C.
4.5.2.2 Manufacturers shall state, in their instructions for use, [see 7.3 e)], any adverse effects on
the performance of their flow control device when subjected to the following operating environmental
conditions:
a) a temperature range of 0 °C to 40 °C; and
b) an atmospheric pressure range of 620 hPa to 1 060 hPa.
Check conformance by inspection of the instructions for use.
5 Design requirements
5.1 General
Flow control devices shall be fitted with a means to prevent particles larger than 100 μm from entering
the gas pathway.
Check conformance by inspection of the technical file.
ISO 15002:2023(E)
5.2 Gas inlets
Gas inlets shall be securely attached to the flow control device and be either:
a) a probe complying with ISO 9170-1:2017 [e.g. see Figure B.2 a)];
NOTE ISO 9170-1:2017 does not specify the design or the dimensions of probes.
b) the nut and nipple of a gas-specific screw-threaded connector in accordance with a recognized
system [e.g. diameter-indexed safety system (DISS), non-interchangeable screw-threaded (NIST)
or sleeve indexed system (SIS), e.g. see Figure B.2 b)]; or
c) a gas specific low-pressure flexible hose assembly complying with ISO 5359 [e.g. see Figures B.2 c)
and B.2 d)].
Check conformance by
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