ISO 19211:2024

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 2024
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ii
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
Foreword
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Subcommittee SC 2, Airway devices and related equipment.
Any feedback or questions on this document should be directed to the user’s national standards body. A
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iv
Introduction
Fire activated oxygen shut-off devices are used to minimise the severity of fires associated with oxygen
therapy. These devices automatically cut off the supply of oxygen in the respiratory therapy tubing and
isolate the oxygen supply as the fire propagates towards the source of supply from the normal ignition site
at the patient interface. It is therefore important that the operating characteristics be specified and tested in
a defined manner.
This document pays particular attention to:
— safety;
— cleanliness;
— performance;
— suitability of materials;
— testing;
— identification; and
— information supplied.
v
International Standard ISO 19211:2024(en)
Anaesthetic and respiratory equipment — Fire-activated
oxygen shut-off devices for use during oxygen therapy
1 Scope
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.
[2]
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 4135, Anaesthetic and respiratory equipment — Vocabulary
ISO 18190:2016, Anaesthetic and respiratory equipment — General requirements for airways and related
equipment
ISO 18562-1, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1:
Evaluation and testing within a risk management process
ISO 80369-2, Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors for
respiratory applications
IEC 60601-1-11:2015+AMD1: 2021, Medical electrical equipment — Part 1-11: General requirements for basic
safety and essential performance — Collateral standard: Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare environment
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4135 and ISO 18190 and the
following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/

3.1
ATPS
volume of gas saturated with water vapour at ambient temperature and barometric pressure
3.2
fire activated oxygen shut-off device
FAOSOD
device that stops the flow of oxygen in respiratory therapy tubing when activated by fire
3.3
manufacturer
natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device
before it is placed on the market under his or her own name, regardless of whether these operations are
carried out by that person or on his or her behalf by a third party
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.55, modified — the notes to entry have been
deleted.]
3.4
shelf-life
maximum period of time that an item can be stored prior to its first use under the conditions described in its
labelling and remain suitable for use
[SOURCE: IEC 60601-1-11:2015, 3.3]
4 General requirements
The requirements of ISO 18
...