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SIST EN ISO 19211:2025

(Main)

Anaesthetic and respiratory equipment - Fire-activated oxygen shut-off devices for use during oxygen therapy (ISO 19211:2024)

Anaesthetic and respiratory equipment - Fire-activated oxygen shut-off devices for use during oxygen therapy (ISO 19211:2024)

This document specifies requirements for fire activated oxygen shut-off devices that stop the flow of oxygen in respiratory therapy tubing when activated by fire.
NOTE 1        Typical arrangements for fire activated oxygen shut-off devices are shown in Annex C.
NOTE 2        Respiratory therapy tubing is covered by ISO 17256.
NOTE 3        Use of fire activated oxygen shut-off devices in medical devices or accessories is not mandated in this document.
The fire activated oxygen shut-off devices specified in this document are not suitable for use with oxygen therapy systems with flows in excess of 20 l/min).
NOTE 4        There is rationale for this clause in A.2.
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.

Anästhesie- und Beatmungsgeräte - Sauerstoff-Absperrvorrichtungen gegen Feuer für die Anwendung bei der Sauerstofftherapie (ISO 19211:2024)

Matériel d'anesthésie et de réanimation respiratoire - Dispositif de coupure de l'oxygène activé par le feu pendant une oxygénothérapie (ISO 19211:2024)

Le présent document spécifie les exigences pour les dispositifs de coupure de l’oxygène activés par le feu qui arrêtent le débit d’oxygène dans la tubulure pour thérapie respiratoire lorsqu’ils sont activés par le feu.
NOTE 1        Les dispositions types pour les dispositifs de coupure de l’oxygène activés par le feu sont indiquées dans l’Annexe C.
NOTE 2        Les tubulures pour thérapie respiratoire sont couvertes par l’ISO 17256[2].
NOTE 3        L’utilisation de dispositifs de coupure de l’oxygène activés par le feu dans les appareils médicaux ou leurs accessoires n’est pas rendue obligatoire dans le présent document.
Les dispositifs de coupure de l’oxygène activés par le feu spécifiés dans le présent document ne sont pas adaptés à une utilisation avec des systèmes d’oxygénothérapie avec des débits supérieurs à 20 l/min.
NOTE 4        La justification de cet article est donnée en A.2.
Les exigences de cette norme spécifique d’un dispositif prévalent sur toute exigence en contradiction spécifiée dans la norme générale relative aux canules (ISO 18190). Toutes les exigences communes figurant dans la norme générale relative aux canules ont été supprimées du présent document.

Anestezijska in dihalna oprema - Naprave za odklop kisika, ki se aktivirajo z ognjem, za uporabo med kisikovo terapijo (ISO 19211:2024)

General Information

Status
Published
Public Enquiry End Date
29-Jun-2025
Publication Date
25-Aug-2025
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
VAZ - Healthcare
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
14-Aug-2025
Due Date
19-Oct-2025
Completion Date
26-Aug-2025
Ref Project
EN ISO 19211:2025 - Anaesthetic and respiratory equipment - Fire-activated oxygen shut-off devices for use during oxygen therapy (ISO 19211:2024)

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SLOVENSKI STANDARD
01-oktober-2025
Anestezijska in dihalna oprema - Naprave za odklop kisika, ki se aktivirajo z
ognjem, za uporabo med kisikovo terapijo (ISO 19211:2024)
Anaesthetic and respiratory equipment - Fire-activated oxygen shut-off devices for use
during oxygen therapy (ISO 19211:2024)
Anästhesie- und Beatmungsgeräte - Sauerstoff-Absperrvorrichtungen gegen Feuer für
die Anwendung bei der Sauerstofftherapie (ISO 19211:2024)
Matériel d'anesthésie et de réanimation respiratoire - Dispositif de coupure de l'oxygène
activé par le feu pendant une oxygénothérapie (ISO 19211:2024)
Ta slovenski standard je istoveten z: EN ISO 19211:2025
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 19211
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2025
EUROPÄISCHE NORM
ICS 11.040.10
English Version
Anaesthetic and respiratory equipment - Fire-activated
oxygen shut-off devices for use during oxygen therapy
(ISO 19211:2024)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Sauerstoff-
Dispositif de coupure de l'oxygène activé par le feu Absperrvorrichtungen gegen Feuer für die Anwendung
pendant une oxygénothérapie (ISO 19211:2024) bei der Sauerstofftherapie (ISO 19211:2024)
This European Standard was approved by CEN on 4 August 2025.

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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 19211:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 19211:2024 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 19211:2025 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 February 2026, and conflicting national standards
shall be withdrawn at the latest by February 2026.
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.
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 19211:2024 has been approved by CEN as EN ISO 19211:2025 without any modification.

International
Standard
ISO 19211
First edition
Anaesthetic and respiratory
2024-08
equipment — Fire-activated oxygen
shut-off devices for use during
oxygen therapy
Matériel d'anesthésie et de réanimation respiratoire —
Dispositif de coupure de l'oxygène activé par le feu pendant une
oxygénothérapie
Reference number
ISO 19211:2024(en) © ISO 2024
ISO 19211:2024(en)
© ISO 2024
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 19211:2024(en)
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 Biological assessment of gas pathways .2
5.3 Oxygen compatibility .2
5.4 Environmental conditions .3
6 Design requirements . 3
6.1 General .3
6.2 Specific design requirements .3
6.3 Inlet connector .3
6.4 Outlet connector .3
6.5 Resistance to flow . .4
6.6 Leakage to atmosphere under maximum static pressure .4
6.7 Leakage to atmosphere during normal use conditions .4
6.8 Activation and prevention of flow of oxygen .5
6.9 Inadvertent disassembly .5
7 Requirements for fire activated oxygen shut-off devices supplied sterile . 5
8 Packaging. 5
8.1 General .5
8.2 Protection during storage and transport .5
9 Information supplied by the manufacturer . 5
9.1 General .5
9.2 Instructions for use .6
Annex A (informative) Rationale . 7
Annex B (normative) Test methods . 9
Annex C (informative) Arrangements of fire activated oxygen shut-off devices .12
Annex D (informative) Hazard identification for the purposes of risk assessment .13
Bibliography . 14

iii
ISO 19211:2024(en)
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
t
...

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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 impairment, which are given in ISO 80601‑2‑79;
—    sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70;
—    high-frequency jet ventilato

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SIST
SIST EN ISO 80369-2:2024(Main)
Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications (ISO 80369-2:2024)
EN ISO 80369-2:2024

This document specifies the design and dimensions for two small-bore connectors intended to be used for connections in respiratory applications of medical devices and accessories. One connector (R1) is intended for use on medical devices and accessories subjected to pressures up to 15 kPa (e.g. a breathing system). The other connector (R2) is intended for use on medical devices and accessories subjected to higher pressures between 15 kPa and 600 kPa (e.g. oxygen therapy tubing).
NOTE 1        The pressure is related to pressure available at the source to which the medical device is connected.
NOTE 2        The intended application does not preclude the use of other connectors on medical devices or accessories within this application.
NOTE 3        Requirements for alternative connectors for this intended application are specified in ISO 80369-1.
This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in device-specific standards.
NOTE 4        If a device-specific standard does not exist, the performance and material requirements specified in ISO 80369-1 can be used as guidance.

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