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SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
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 23372:2022(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: [email protected]
Website: www.iso.org
Published in Switzerland
ii
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 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.
iv
ISO 23372:2022(E)
Introduction
Air entrainment devices, commonly known as venturi masks, are used to provide a known concentration
of oxygen to a patient at a known set flow. This is achieved by driving the oxygen through a controlled
diameter orifice and entraining room air through side openings These devices are available in various
concentrations and can ensure continuity over a long period of time within relatively close limits of
accuracy.
However, the use of these devices does not guarantee that the patient receives the designated oxygen
concentration as there are physiological factors such as the patient’s ventilatory pattern, lung
compliance and airway resistance, and physical factors such as the fit of the mask, movement by the
[2]
patient, etc .
v
INTERNATIONAL STANDARD ISO 23372:2022(E)
Anaesthetic and respiratory equipment — Air entrainment
devices
1 Scope
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).
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requi
...