EN ISO 19211:2025 PDF

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

Название (английский):

EN ISO 19211:2025

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

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 22
Дата публикации:: 6 августа 2025 г.
Издание:: CEN EN 19211 edition 1 version 1
ICS:: 11.040.10

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Описание (английский):

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.

Технические детали

Технический комитет: CEN/TC 215 - Respiratory and anaesthetic equipment
SKU: EN ISO 19211:2025

Abstract

Overview

EN ISO 19211:2025 (identical to ISO 19211:2024) specifies safety and performance requirements for fire‑activated oxygen shut‑off devices used during oxygen therapy. These devices are intended to stop the flow of oxygen in respiratory therapy tubing when activated by fire, reducing the severity and propagation of fires at the patient interface. The standard applies to devices for typical respiratory tubing configurations and explicitly excludes systems with oxygen flows above 20 l/min.

Key topics and technical requirements

Scope and applicability
- Defines the function of fire‑activated oxygen shut‑off devices (FAOSOD) and limits use to oxygen systems ≤ 20 l/min.
- Clarifies that use of FAOSOD in medical devices is not mandated by the standard.
Materials and biocompatibility
- Requirements for materials in gas pathways and biological assessment aligned with ISO 18562 series.
- Oxygen compatibility to avoid ignition or degradation.
Design and performance
- Design requirements for inlet/outlet connectors, resistance to flow, and prevention of inadvertent disassembly.
- Limits on leakage to atmosphere under static and normal-use conditions.
- Activation characteristics that reliably stop oxygen flow when exposed to fire.
Testing and verification
- Device‑specific test methods are provided (see Annex B) for performance validation.
- Annex A gives rationale for specific clauses and Annex C shows typical device arrangements.
Packaging, sterilization and information
- Requirements for packaging and protection during storage/transport.
- Provisions for sterile supply where applicable and mandatory manufacturer information/instructions for use.
Standards precedence
- Device-specific requirements override any conflicting requirements in the general airway devices standard (ISO 18190); common requirements from ISO 18190 are removed here.

Applications and users

Primary users
- Medical device manufacturers and designers of respiratory therapy accessories.
- Clinical engineers, hospital procurement teams, and infection control specialists.
- Testing laboratories, conformity assessment bodies, and notified bodies.
Practical uses
- Integration into oxygen therapy circuits to reduce fire risk at patient interfaces (masks, cannulas, ventilator circuits).
- Risk mitigation in hospitals, homecare oxygen therapy, and transport settings (subject to flow limit).

Related standards

ISO 17256 - respiratory therapy tubing
ISO 18190 - general requirements for airway devices (superseded in conflict by EN ISO 19211)
ISO 18562 series - biocompatibility of breathing gas pathways
ISO 80369-2 - small-bore connectors for respiratory applications

Keywords: EN ISO 19211:2025, fire-activated oxygen shut-off devices, oxygen therapy, respiratory therapy tubing, ISO 19211:2024, medical device standard, oxygen shut-off, ISO 18190, ISO 17256.

Overview

Key topics and technical requirements

Scope and applicability
- Defines the function of fire‑activated oxygen shut‑off devices (FAOSOD) and limits use to oxygen systems ≤ 20 l/min.
- Clarifies that use of FAOSOD in medical devices is not mandated by the standard.
Materials and biocompatibility
- Requirements for materials in gas pathways and biological assessment aligned with ISO 18562 series.
- Oxygen compatibility to avoid ignition or degradation.
Design and performance
- Design requirements for inlet/outlet connectors, resistance to flow, and prevention of inadvertent disassembly.
- Limits on leakage to atmosphere under static and normal-use conditions.
- Activation characteristics that reliably stop oxygen flow when exposed to fire.
Testing and verification
- Device‑specific test methods are provided (see Annex B) for performance validation.
- Annex A gives rationale for specific clauses and Annex C shows typical device arrangements.
Packaging, sterilization and information
- Requirements for packaging and protection during storage/transport.
- Provisions for sterile supply where applicable and mandatory manufacturer information/instructions for use.
Standards precedence
- Device-specific requirements override any conflicting requirements in the general airway devices standard (ISO 18190); common requirements from ISO 18190 are removed here.

Applications and users

Primary users
- Medical device manufacturers and designers of respiratory therapy accessories.
- Clinical engineers, hospital procurement teams, and infection control specialists.
- Testing laboratories, conformity assessment bodies, and notified bodies.
Practical uses
- Integration into oxygen therapy circuits to reduce fire risk at patient interfaces (masks, cannulas, ventilator circuits).
- Risk mitigation in hospitals, homecare oxygen therapy, and transport settings (subject to flow limit).

Related standards

ISO 17256 - respiratory therapy tubing
ISO 18190 - general requirements for airway devices (superseded in conflict by EN ISO 19211)
ISO 18562 series - biocompatibility of breathing gas pathways
ISO 80369-2 - small-bore connectors for respiratory applications

Keywords: EN ISO 19211:2025, fire-activated oxygen shut-off devices, oxygen therapy, respiratory therapy tubing, ISO 19211:2024, medical device standard, oxygen shut-off, ISO 18190, ISO 17256.

EN ISO 19211:2025 PDF

Технические детали

Abstract

Overview

Key topics and technical requirements

Applications and users

Related standards

Похожие стандарты

Abstract

Overview

Key topics and technical requirements

Applications and users

Related standards

Похожие стандарты

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