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CEN

EN ISO 23371:2022

(Main)

Anaesthetic and respiratory equipment - Cuff pressure indication, control and regulation devices (ISO 23371:2022)

Anaesthetic and respiratory equipment - Cuff pressure indication, control and regulation devices (ISO 23371:2022)

This document specifies essential performance and safety requirements for cuff pressure indicators used to indicate the intracuff pressure of airway devices, such as supralaryngeal airways, tracheal tubes or tracheostomy tubes.
This document is also applicable to devices that combine intracuff pressure indication with a method of cuff inflation (such as a syringe or pump). The device can also provide a method of automatically maintaining cuff inflation at a specific pressure or within a pressure range.
The requirements specified in this document apply to stand-alone cuff pressure indicators and those integrated into other medical devices e.g. ventilators anaesthesia workstations etc.

Anästhesie- und Beatmungsgeräte - Cuffdruckanzeiger und Cuffdruckregulierungsvorrichtungen (ISO 23371:2022)

Dieses Dokument legt wesentliche Leistungs- und Sicherheitsanforderungen von Cuffdruckanzeigen fest, mit denen der cuffinterne Druck von Atemwegsvorrichtungen, beispielsweise von supralaryngalen Atemwegen, Trachealtuben oder Tracheotomietuben, angezeigt wird.
Dieses Dokument ist auch für Produkte anwendbar, die die Anzeige des cuffinternen Drucks mit einer Methode zum Aufblasen des Cuffs (wie eine Spritze oder Pumpe) kombinieren. Das Produkt kann auch eine Methode zur automatischen Aufrechterhaltung des aufgeblasenen Cuffs bei einem bestimmten Druck oder innerhalb eines Druckbereichs bereitstellen.
Die in diesem Dokument angegebenen Anforderungen gelten sowohl für eigenständige Cuffdruckanzeiger als auch für Produkte, die in anderen Medizinprodukten integriert sind, wie z. B. in Beatmungsgeräten oder Anästhesie-Arbeitsplätzen usw.

Matériel d’anesthésie et de réanimation respiratoire - Dispositifs d’indication, de contrôle et de régulation de la pression du ballonnet (ISO 23371:2022)

Le présent document spécifie les exigences en matière de performances essentielles et de sécurité des indicateurs de pression du ballonnet utilisés pour indiquer la pression intraballonnet des dispositifs de voie aérienne, tels que les canules supralaryngées, les sondes trachéales ou les canules de trachéotomie.
Le présent document est également applicable aux dispositifs qui combinent l’indication de la pression intraballonnet à une méthode de gonflage du ballonnet (par exemple, seringue ou pompe). Le dispositif peut également fournir un moyen pour maintenir automatiquement le gonflage du ballonnet à une pression donnée ou dans une plage de pressions.
Les exigences spécifiées dans le présent document s’appliquent aux indicateurs de pression du ballonnet indépendants ainsi qu’à ceux intégrés à d’autres dispositifs médicaux, tels que des ventilateurs, des systèmes d’anesthésie, etc.

Anestezijska in dihalna oprema - Naprave za merjenje, kontrolo in regulacijo pritiska v balončku (ISO 23371:2022)

Ta dokument določa zahteve za bistvene lastnosti in varnost indikatorjev pritiska v balončkih, ki so namenjeni prikazovanju pritiska v balončku pripomočkov za dihalne poti, kot so supralaringealne dihalne cevke, trahealni tubusi ali traheostomski tubusi. Ta dokument se uporablja tudi za pripomočke, ki poleg prikaza pritiska v balončku omogočajo tudi metodo napihovanja balončka (na primer brizga ali črpalka). Pripomoček lahko zagotavlja tudi metodo samodejnega vzdrževanja pritiska v balončku na določeni vrednosti ali v določenem območju pritiska. Zahteve, določene v tem dokumentu, se uporabljajo za samostojne indikatorje pritiska v balončku in indikatorje pritiska, ki so vgrajeni v druge medicinske pripomočke (npr. ventilatorje, delovna mesta za anestezijo itd.).

General Information

Status
Published
Publication Date
31-May-2022
Withdrawal Date
30-Dec-2022
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
6060 - Definitive text made available (DAV) - Publishing
Start Date
01-Jun-2022
Completion Date
01-Jun-2022
Ref Project
SIST EN ISO 23371:2022 - Anaesthetic and respiratory equipment - Cuff pressure indication, control and regulation devices (ISO 23371:2022)

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SLOVENSKI STANDARD
01-september-2022
Anestezijska in dihalna oprema - Naprave za merjenje, kontrolo in regulacijo
pritiska v balončku (ISO 23371:2022)
Anaesthetic and respiratory equipment - Cuff pressure indication, control and regulation
devices (ISO 23371:2022)
Anästhesie- und Beatmungsgeräte - Cuffdruckanzeiger und
Cuffdruckregulierungsvorrichtungen (ISO 23371:2022)
Matériel d’anesthésie et de réanimation respiratoire - Dispositifs d’indication, de contrôle
et de régulation de la pression du ballonnet (ISO 23371:2022)
Ta slovenski standard je istoveten z: EN ISO 23371:2022
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 23371
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2022
EUROPÄISCHE NORM
ICS 11.040.10
English Version
Anaesthetic and respiratory equipment - Cuff pressure
indication, control and regulation devices (ISO
23371:2022)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte -
Dispositifs d'indication, de contrôle et de régulation de Manschettendruck-Anzeigegeräte (ISO 23371:2022)
la pression du ballonnet (ISO 23371:2022)
This European Standard was approved by CEN on 17 March 2022.

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, Turkey 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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23371:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 23371:2022) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with 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 December 2022, and conflicting national standards
shall be withdrawn at the latest by December 2022.
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.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. 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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 23371:2022 has been approved by CEN as EN ISO 23371:2022 without any modification.

INTERNATIONAL ISO
STANDARD 23371
First edition
2022-05
Anaesthetic and respiratory
equipment — Cuff pressure indication,
control and regulation devices
Matériel d’anesthésie et de réanimation respiratoire — Dispositifs
d’indication, de contrôle et de régulation de la pression du ballonnet
Reference number
ISO 23371:2022(E)
ISO 23371:2022(E)
© ISO 2022
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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 23371:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
4.1 General . 2
4.2 Alternative test methods . 2
5 Materials . 3
6 Design requirements .3
6.1 General . 3
6.2 Metrological requirements . 3
6.3 Connectors . 4
6.4 Integrated cuff pressure indicators . 4
6.5 Mechanical strength . 5
7 Requirements for Cuff pressure indication, control and regulation devices supplied
sterile . 5
8 Packaging. 6
9 Information supplied by the manufacturer . 6
9.1 General . 6
9.2 Marking . 6
9.2.1 General . 6
9.2.2 Markings . 6
9.3 Instructions for use . 6
Annex A (Informative) Rationale . 8
Bibliography . 9
iii
ISO 23371:2022(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 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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
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 2, Airways and related equipment, in collaboration with the European
Committee for Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic
equipment, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement).
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.
iv
ISO 23371:2022(E)
Introduction
This document provides the essential performance and safety requirements for the design of cuff
pressure indication and/or regulation devices for use with airway products. Cuffs on tracheal tubes and
tracheostomy tubes are intended to seal and protect the trachea from aspiration of secretions and to
provide an unobstructed airway in patients during spontaneous, assisted or controlled ventilation for
short or prolonged durations. Supralaryngeal airways feature an inflatable cuff to provide a guide for
insertion and
...

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NOTE 5       See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. 
This document does not specify the requirements for:
—    ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12;
—    ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13;
—    ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84;
—    ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72;
—    ventilatory support equipment or accessories intended for ventilatory insufficiency, which are given in ISO 80601‑2‑80;
—    sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70;
—    high-frequency jet ventilators (HFJVs), which are given in ISO 80601‑2‑87;
—    high-frequency oscillatory ventilators (HFOVs);
—    respiratory high flow equipment, which are given in

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EN ISO 5362:2024(Main)
Anaesthetic and respiratory equipment - Anaesthetic reservoir bags (ISO 5362:2024)
SIST EN ISO 5362:2024

This document specifies requirements for anaesthetic reservoir bags for use with anaesthetic and ventilator breathing systems. It includes requirements for the design of the neck, size designation and elasticity.
This document is not applicable to special-purpose bags, for example bellows, self-inflating bags and bags for use with anaesthetic gas scavenging systems.
The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190). All the common requirements that appear in the general standard for airway devices have been removed from this document.

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EN ISO 16571:2024(Main)
Systems for evacuation of plume generated by medical devices (ISO 16571:2024)
SIST EN ISO 16571:2024

This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices.
 This document applies to all types of plume evacuation systems (PESs), including
a)       portable;
b)       mobile;
c)        stationary, including dedicated central pipelines;
d)       PESs integrated into other equipment;
e)       PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic)
This document applies to all healthcare facilities where PESs are used, including, but not limited to
a)       surgical facilities;
b)       medical offices;
c)        cosmetic treatment facilities;
d)       medical teaching facilities;
e)       dental clinics;
f)         veterinary facilities.
This document provides guidance on the following aspects of PESs:
a)       importance;
b)       purchasing;
c)        design;
d)       manufacture;
e)       documentation;
f)         function;
g)       performance;
h)       installation;
i)         commissioning;
j)         testing;
k)       training;
l)         use;
m)     risk assessment;
n)       servicing;
o)       maintenance.
This document does not apply to the following:
a)       anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2;
b)       medical vacuum systems which are covered in ISO 7396-1;
c)        heating, ventilation, and air-conditioning (HVAC) systems;
d)       aspects of laser safety other than airborne contamination; and
e)       aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.

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EN ISO 15002:2024(Main)
Flow control devices for connection to a medical gas supply system (ISO 15002:2023)
SIST EN ISO 15002:2024

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).

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EN ISO 80601-2-55:2018/A1:2023(Amendment)
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-55:2018/Amd 1:2023)
SIST EN ISO 80601-2-55:2018/A1:2024
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