SIST 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
Overview
EN ISO 23371:2022 - Anaesthetic and respiratory equipment: Cuff pressure indication, control and regulation devices (ISO 23371:2022) specifies essential performance and safety requirements for devices that indicate, inflate/deflate, control or automatically regulate the intracuff pressure of airway devices (tracheal tubes, tracheostomy tubes, supralaryngeal airways). The standard applies to stand‑alone cuff pressure indicators and those integrated into other medical systems (e.g. ventilators, anaesthesia workstations), and to devices that combine pressure indication with an inflation method (syringe, pump) or automatic pressure maintenance.
Key topics and requirements
- Scope and definitions: Clear definitions for cuff, airway device, cuff inflation device, cuff pressure indicator and automatic cuff pressure regulator.
- General performance & safety: Essential performance criteria for reliable intracuff pressure measurement and control to reduce harm from over‑ or under‑inflation.
- Metrological requirements: Accuracy, repeatability and traceability expectations for pressure indication (metrological specifics are defined in the standard).
- Design and connectors: Requirements for safe mechanical design, compatible connectors and integration with airway devices and patient circuits.
- Integrated and automatic regulators: Guidance for devices that maintain cuff pressure automatically or combine indication with inflation/deflation mechanisms.
- Mechanical strength and sterile supply: Tests for durability, strength and requirements where devices are supplied sterile.
- Packaging, marking and documentation: Mandatory manufacturer information, labeling, instructions for use and packaging requirements to ensure safe clinical use.
- Testing and alternative methods: Provisions for test methods and acceptable alternative verification approaches.
Practical applications and users
- Medical device manufacturers developing cuff pressure indicators, automatic cuff regulators, or integrating cuff pressure functions into ventilators and anaesthesia workstations.
- Clinical engineering, procurement and conformity assessment teams using the standard for design validation, regulatory compliance and product selection.
- Hospitals and critical care clinicians (ICU, anaesthesia, emergency medicine) using devices to reduce risks such as mucosal ischemia, aspiration and ventilator‑associated pneumonia by maintaining appropriate cuff pressures.
- Notified bodies and regulators assessing device safety and performance for market approval.
Related standards
- ISO 18190 - General requirements for airways and related equipment (referenced normative).
- ISO 80369‑7 - Small‑bore connectors for healthcare (connector safety).
- IEC 60601‑1‑8 - Alarm systems for medical electrical equipment (where applicable).
EN ISO 23371:2022 is essential for anyone designing, evaluating or procuring cuff pressure devices to ensure safe, accurate intracuff pressure control and compliance with international safety expectations.
Frequently Asked Questions
SIST EN ISO 23371:2022 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Anaesthetic and respiratory equipment - Cuff pressure indication, control and regulation devices (ISO 23371:2022)". This standard covers: 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.
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.
SIST EN ISO 23371:2022 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.
You can purchase SIST EN ISO 23371:2022 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of SIST standards.
Standards Content (Sample)
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 stability of the airway. A variety of cuff designs are available to meet particular clinical
requirements. Cuffs on tracheal tubes and tracheostomy tubes function by forming a seal between the
airway device and the epithelial lining of the patient’s airway. A pressure will be exerted on the lining
of the airway where it makes contact with the cuff. Inflation of the airway cuff such that the pressure
exerted on the epithelium is in excess of the capillary perfusion pressure can result in ischemia of
the epithelium. This can result in short or long-term morbidity ranging from mild (e.g. sore throat) to
[1]
severe (e.g. subglottic stenosis) . Overinflated cuffs on supralaryngeal airways can cause injuries such
as damage to the lingual, hypoglossal or recurrent laryngeal nerves in addition to arytenoid dislocation,
[2]
haematoma, tongue swelling and cyanosis . Uncontrolled low airway cuff pressure can also increase
[3,4]
the risk of micro-aspiration and ventilator-associated pneumonia .
Tracheal tube and tracheostomy tube cuff pressures have traditionally been assessed by the clinician at
the time of cuff inflation. Typically this is done by listening for a leak at the mouth while inflating the
cuff with positive pressure applied to the airway until the user can no longer appreciate a leak. Evidence
[5]
suggests that such methods of clinical assessment of airway cuff pressure are inaccurate . A number
[6]
of clinical guidelines now recommend the measurement of cuff pressure using a suitable device .
Throughout this document the following print types are used:
— Requirements and definitions: roman type;
— Informative material appearing outside of tables, such as notes, examples and references: smaller
type. The Normative text of tables is also in smaller type;
— Terms defined in Clause 3: italic type.
v
INTERNATIONAL STANDARD ISO 23371:
...
기사 제목: SIST EN ISO 23371:2022 - 마취 및 호흡 장비 - 마포압 표시, 제어 및 조절 장치 (ISO 23371:2022) 기사 내용: 이 문서는 상부후두공기로, 기관관, 또는 기관절개관과 같은 기도 장치의 마포압을 나타내는데 사용되는 마포압 표시기의 필수 성능 및 안전 요구 사항을 명시합니다. 이 문서는 마포압 표시와 마포 팽창 방법(주사기 또는 펌프 등)을 결합한 장치에도 적용됩니다. 이 장치는 특정 압력 또는 압력 범위 내에서 자동으로 마포 팽창을 유지하는 방법을 제공할 수도 있습니다. 이 문서에 명시된 요구 사항은 독립형 마포압 표시기와 의료 기기(예: 환기기, 마취 작업장 등)에 통합된 마포압 표시기 모두에 적용됩니다.
記事タイトル：SIST EN ISO 23371:2022 - 麻酔と呼吸器機器 - カフの圧力表示、制御、および調節装置 (ISO 23371:2022) 記事内容：この文書では、上喉頭気道、気管管、または気管切開管などの気道装置の中カフ圧力を示すために使用されるカフ圧力表示装置の必須性能と安全要件が規定されています。 この文書は、注入器やポンプなどのカフの充填方法とカフ圧力表示を組み合わせた装置にも適用されます。この装置は、特定の圧力または圧力範囲内で自動的にカフの充填を保持する方法も提供できます。 この文書で指定された要件は、スタンドアロンのカフ圧力表示装置および呼吸器や麻酔装置といった他の医療機器に統合された装置に適用されます。
The article discusses the SIST EN ISO 23371:2022 standard, which sets requirements for cuff pressure indication, control, and regulation devices used in anaesthetic and respiratory equipment. These devices are used to measure and control the pressure within airway devices such as supralaryngeal airways, tracheal tubes, or tracheostomy tubes. The standard applies to standalone cuff pressure indicators as well as those integrated into other medical devices like ventilators and anaesthesia workstations. The devices may also include features for automatically maintaining cuff inflation at a specific pressure or within a pressure range.
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