Anaesthetic and respiratory equipment - Air entrainment devices (ISO 23372:2022)

This document specifies minimum performance and safety requirements for air entrainment devices
used for delivery of designated oxygen concentrations to patients. It provides a test method to check
the accuracy of the oxygen concentration in the air/oxygen mixture generated by the air entrainment
devices. Air entrainment devices can be fixed to deliver a single oxygen concentration or adjustable, to
deliver a range of oxygen concentration outputs.
This document also specifies marking requirements and recommends an optional system of colour
coding to assist the user in identifying the designated oxygen concentration.
This document does not cover air entrainment devices which are integral with medical devices specified
in other standards (e.g. emergency lung ventilators, humidifiers, nebulizers).

Atemtherapiegeräte - Luftbeimischgeräte (ISO 23372:2022)

Dieses Dokument legt Mindestanforderungen an die Leistungsfähigkeit und Sicherheit von Luftbeimischgeräten fest, die für die Abgabe festgelegter Sauerstoffkonzentrationen an Patienten verwendet werden. Es enthält ein Prüfverfahren zur Überprüfung der Genauigkeit der Sauerstoffkonzentration im Luft-Sauerstoff-Gemisch, das durch das Luftbeimischgerät erzeugt wird. Luftbeimischgeräte können so eingestellt sein, dass sie nur eine Sauerstoffkonzentration bereitstellen oder einstellbar sein, um einen Bereich von Sauerstoffkonzentrationen abzugeben.
Es legt auch Anforderungen an die Kennzeichnung fest und enthält Empfehlungen an ein wahlweises Farbcodierungssystem, das den Anwender bei der Identifizierung der bestimmten Sauerstoffkonzentration unterstützt.
Dieses Dokument behandelt keine Luftbeimischgeräte, die ein integraler Teil von medizinischen Geräten sind, für die in anderen Normen Festlegungen bestehen, z. B. Beatmungsgeräte für den Notfall, Anfeuchter, Vernebler usw.

Matériel d’anesthésie et de réanimation respiratoire - Dispositifs d’entraînement d’air (ISO 23372:2022)

Le présent document spécifie les exigences de sécurité et de performance minimales des dispositifs d’entraînement d’air utilisés pour administrer des concentrations en oxygène désignées aux patients. Il fournit une méthode d’essai permettant de vérifier la précision de la concentration en oxygène dans le mélange air/oxygène généré par les dispositifs d’entraînement d’air. Les dispositifs d’entraînement d’air peuvent être réglés pour administrer une seule concentration en oxygène ou une gamme de concentrations en oxygène.
Le présent document spécifie également des exigences de marquage et recommande un système optionnel de code couleurs pour aider l’utilisateur à identifier la concentration en oxygène désignée.
Le présent document ne traite pas des dispositifs d’entraînement d’air qui sont intégrés à des dispositifs médicaux spécifiés dans d’autres normes (par exemple les ventilateurs pulmonaires d’urgence, les humidificateurs, les nébuliseurs).

Anestezijska in dihalna oprema - Vhodne naprave za zrak (ISO 23372:2022)

General Information

Status
Published
Public Enquiry End Date
04-Sep-2019
Publication Date
15-Jun-2022
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
03-Jun-2022
Due Date
08-Aug-2022
Completion Date
16-Jun-2022

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SLOVENSKI STANDARD
SIST EN ISO 23372:2022
01-julij-2022
Nadomešča:
SIST EN 13544-3:2002+A1:2009
Anestezijska in dihalna oprema - Vhodne naprave za zrak (ISO 23372:2022)
Anaesthetic and respiratory equipment - Air entrainment devices (ISO 23372:2022)
Atemtherapiegeräte - Luftbeimischgeräte (ISO 23372:2022)

Matériel d’anesthésie et de réanimation respiratoire - Dispositifs d’entraînement d’air

(ISO 23372:2022)
Ta slovenski standard je istoveten z: EN ISO 23372:2022
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 23372:2022 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 23372:2022
---------------------- Page: 2 ----------------------
SIST EN ISO 23372:2022
EN ISO 23372
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2022
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN 13544-3:2001+A1:2009
English Version
Anaesthetic and respiratory equipment - Air entrainment
devices (ISO 23372:2022)

Matériel d'anesthésie et de réanimation respiratoire - Atemtherapiegeräte - Luftbeimischgeräte (ISO

Dispositifs d'entraînement d'air(ISO 23372:2022) 23372:2022)
This European Standard was approved by CEN on 7 February 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 23372:2022 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 23372:2022
EN ISO 23372:2022 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
SIST EN ISO 23372:2022
EN ISO 23372:2022 (E)
European foreword

This document (EN ISO 23372:2022) 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 November 2022, and conflicting national standards

shall be withdrawn at the latest by November 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.

This document supersedes EN 13544-3:2001+A1:2009.

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 23372:2022 has been approved by CEN as EN ISO 23372:2022 without any modification.

---------------------- Page: 5 ----------------------
SIST EN ISO 23372:2022
---------------------- Page: 6 ----------------------
SIST EN ISO 23372:2022
INTERNATIONAL ISO
STANDARD 23372
First edition
2022-05
Anaesthetic and respiratory
equipment — Air entrainment devices
Matériel d’anesthésie et de réanimation respiratoire — Dispositifs
d’entraînement d’air
Reference number
ISO 23372:2022(E)
© ISO 2022
---------------------- Page: 7 ----------------------
SIST EN ISO 23372:2022
ISO 23372:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
© ISO 2022 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 23372:2022
ISO 23372:2022(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction .................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ..................................................................................................................................................................................... 1

3 Terms and definitions .................................................................................................................................................................................... 1

4 General requirements .................................................................................................................................................................................... 2

5 Materials ....................................................................................................................................................................................................................... 2

5.1 General ........................................................................................................................................................................................................... 2

5.2 Biocompatibility of breathing gas pathways ............................................................................................................... 2

6 Design requirements .......................................................................................................................................................................................2

6.1 General ........................................................................................................................................................................................................... 2

6.2 Oxygen inlet connectors ................................................................................................................................................................ 3

6.3 Outlet connectors ................................................................................................................................................................................. 3

6.4 Air inlet attachments ........................................................................................................................................................................ 3

7 Information to be provided by the manufacturer ............................................................................................................ 3

7.1 General ........................................................................................................................................................................................................... 3

7.2 Marking ......................................................................................................................................................................................................... 3

7.3 Instructions for use ............................................................................................................................................................................ 4

Annex A (normative) Test method for delivered oxygen concentration .......................................................................5

Bibliography ................................................................................................................................................................................................................................ 8

iii
© ISO 2022 – All rights reserved
---------------------- Page: 9 ----------------------
SIST EN ISO 23372:2022
ISO 23372:2022(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.
© ISO 2022 – All rights reserved
----------
...

SLOVENSKI STANDARD
oSIST prEN ISO 23372:2019
01-september-2019
Oprema za zdravljenje motenj dihanja: Vhodne naprave za zrak (ISO/DIS
23372:2019)
Respiratory therapy equipment: Air entrainment devices (ISO/DIS 23372:2019)

Appareils de thérapie respiratoire - Dispositifs d'entraînement d'air (ISO/DIS 23372:2019)

Ta slovenski standard je istoveten z: prEN ISO 23372
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 23372:2019 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 23372:2019
---------------------- Page: 2 ----------------------
oSIST prEN ISO 23372:2019
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23372
ISO/TC 121/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2019-06-14 2019-09-06
Respiratory therapy equipment — Air entrainment devices
Appareils de thérapie respiratoire — Dispositifs d'entraînement d'air
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 23372:2019(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2019
---------------------- Page: 3 ----------------------
oSIST prEN ISO 23372:2019
ISO/DIS 23372:201x
ISO/DIS 23372:2019(E)
Contents

Foreword .............................................................................................................................................5

Introduction ........................................................................................................................................6

1 Scope.............................................................................................................................................7

2 Normative references................................................................................................................7

3 Terms and definitions...............................................................................................................8

4 General requirements...............................................................................................................8

5 Materials ......................................................................................................................................8

6 Design requirements.................................................................................................................8

6.1 General .....................................................................................................................................8

6.2 Oxygen inlet connector ........................................................................................................9

6.4 Air inlet attachments............................................................................................................9

7 Information supplied by the manufacturer..........................................................................9

7.1 Marking ....................................................................................................................................9

7.2 Instructions for use..............................................................................................................10

Annex A (normative) Test method for delivered oxygen concentration.......................................11

Bibliography......................................................................................................................................13

COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
© ISO #### – All rights reserved 3
---------------------- Page: 4 ----------------------
oSIST prEN ISO 23372:2019
ISO/DIS 23372:2019(E)
Contents

Foreword ............................................................................................................................................. 5

Introduction ........................................................................................................................................ 6

1 Scope ............................................................................................................................................. 7

2 Normative references ................................................................................................................ 7

3 Terms and definitions ............................................................................................................... 8

4 General requirements ............................................................................................................... 8

5 Materials ...................................................................................................................................... 8

6 Design requirements ................................................................................................................. 8

6.1 General ..................................................................................................................................... 8

6.2 Oxygen inlet connector ........................................................................................................ 9

6.4 Air inlet attachments ............................................................................................................ 9

7 Information supplied by the manufacturer .......................................................................... 9

7.1 Marking .................................................................................................................................... 9

7.2 Instructions for use .............................................................................................................. 10

Annex A (normative) Test method for delivered oxygen concentration ....................................... 11

Bibliography ...................................................................................................................................... 13

© ISO 2019 – All rights reserved
---------------------- Page: 5 ----------------------
oSIST prEN ISO 23372:2019
---------------------- Page: 6 ----------------------
oSIST prEN ISO 23372:2019
ISO/DIS 23372:2019(E)
1 Foreword

2 ISO (the International Organization for Standardization) is a worldwide federation of national

3 standards bodies (ISO member bodies). The work of preparing International Standards is normally

4 carried out through ISO technical committees. Each member body interested in a subject for which a

5 technical committee has been established has the right to be represented on that committee.

6 International organizations, governmental and non-governmental, in liaison with ISO, also take part in

7 the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all

8 matters of electrotechnical standardization.

9 The procedures used to develop this document and those intended for its further maintenance are

10 described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

11 different types of ISO documents should be noted. This document was drafted in accordance with the

12 editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives

13 Attention is drawn to the possibility that some of the elements of this document may be the subject of

14 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

15 any patent rights identified during the development of the document will be in the Introduction and/or

16 on the ISO list of patent declarations received. www.iso.org/patents

17 Any trade name used in this document is information given for the convenience of users and does not

18 constitute an endorsement.

19 For an explanation on the meaning of ISO specific terms and expressions related to conformity

20 assessment, as well as information about ISO's adherence to the WTO principles in the Technical

21 Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information

22 The committee responsible for this document is ISO/TC 121/SC2.

23 This is the first edition which is based on the European standard EN 13544-3:2005 Amd 1:2009 and

24 aligns with ISO 18190:2016 the General standard for airway devices.
25 Throughout this International Standard the following print types are used:
26  Requirements and definitions: roman type;
27  Compliance tests: italic type;

28  Informative material appearing outside of tables, such as notes, examples and references: smaller type.

29 The Normative text of tables is also in smaller type;
30  terms defined in clause 3: green italic.

31 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates

32 that there is guidance or rationale related to that item in Annex A.

33 The attention of Member Bodies and National Committees is drawn to the fact that equipment

34 manufacturers and testing organizations may need a transitional period following publication of a new,

35 amended or revised ISO or IEC publication in which to make products in accordance with the new

36 requirements and to equip themselves for conducting new or revised tests. It is the recommendation of

37 the committee that the content of this publication be adopted for implementation nationally not earlier

38 than 3 years from the date of publication for equipment newly designed and not earlier than 5 years

39 from the date of publication for equipment already in production.
© ISO 2019 – All rights reserved
---------------------- Page: 7 ----------------------
oSIST prEN ISO 23372:2019
ISO/DIS 23372:2019(E)
41 Introduction

42 Air entrainment devices, commonly known as venturi masks, are used to provide a known concentration

43 of oxygen to a patient at a known set flow. They achieve this by driving the oxygen through a controlled

[1]

44 diameter orifice and entraining room air through side openings. These devices are available in

45 various concentrations and can ensure continuity over a long period of time within relatively close

46 limits of accuracy.

47 However, the use of these devices does not guarantee that the patient receives the designated oxygen

48 concentration as there are physiological factors such as the patient’s ventilator pattern, lung compliance

[2]

49 and airway resistance and physical factors such as the fit of the mask, movement by the patient etc.

© ISO 2019 – All rights reserved
---------------------- Page: 8 ----------------------
oSIST prEN ISO 23372:2019
ISO/DIS 23372:2019(E)
50 Respiratory therapy equipment – Air entrainment devices
51 1 Scope
52 ISO 18190:2016 Clause 1 is replaced by:

53 This document specifies minimum performance and safety requirements for air entrainment

54 devices used for delivery of designated oxygen concentrations to patients and includes a test

...

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