ISO 19211-2024 PDF

Full title and description

ISO 19211:2024 — Anaesthetic and respiratory equipment — Fire-activated oxygen shut-off devices for use during oxygen therapy. This international standard specifies device-specific safety, design, material, performance, testing and information requirements for devices that automatically stop the flow of oxygen in respiratory therapy tubing when activated by fire.

Abstract

ISO 19211:2024 defines requirements and verifiable test methods for fire‑activated oxygen shut‑off devices intended for oxygen therapy tubing (not suitable for systems with flows > 20 l/min). The document removes common requirements already covered by the general airway devices standard (ISO 18190) so that device‑specific provisions take precedence where they conflict. Annexes provide typical arrangements and rationale for selected limits.

General information

• Status: Published (International Standard).
• Publication date: 30 August 2024 (Edition 1, 2024-08).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.10 – Anaesthetic, respiratory and reanimation equipment.
• Edition / version: Edition 1 (2024).
• Number of pages: 14 pages.

Core bibliographic details above are taken from the ISO record for ISO 19211:2024.

Scope

This standard specifies requirements for fire‑activated oxygen shut‑off devices that stop oxygen flow in respiratory therapy tubing when actuated by fire. It is limited to devices suitable for therapy systems with flows up to and including 20 l/min and explicitly states that its device‑specific requirements take precedence over conflicting requirements in the general airway devices standard (ISO 18190). Typical device arrangements are illustrated in an annex.

Key topics and requirements

• Device safety and functional behaviour when activated by fire (stop‑flow performance and reliability).
• Design and material requirements including oxygen compatibility and biocompatibility considerations.
• Performance limits (suitability for therapy flows ≤ 20 l/min) and related rationale.
• Verifiable test methods and acceptance criteria (performance testing and verification procedures).
• Information and labelling requirements for safe selection, installation and use.
• Precedence of device‑specific requirements over general airway device requirements where conflicts occur.

Summary of technical scope and normative orientation derived from the ISO standard and commercial standards catalogues.

Typical use and users

Typical users include medical device manufacturers (design and conformity assessment of oxygen therapy accessories), test laboratories and conformity assessment bodies, hospital biomedical engineering teams, clinical risk managers, and regulatory or market surveillance authorities involved with medical gas safety. Procurement and standards teams in hospitals and device‑testing labs will use the standard to specify and verify product behaviour in fire scenarios.

Related standards

Common normative and related references include ISO 18190 (Anaesthetic and respiratory equipment — General requirements for airways and related equipment), ISO 17256 (respiratory therapy tubing), IEC 60601‑1‑11 (medical electrical equipment — home healthcare), and ISO 80369‑2 (small‑bore connectors for respiratory applications). The device‑specific requirements in ISO 19211 take precedence over conflicting clauses in ISO 18190.

Keywords

fire‑activated shut‑off, oxygen shut‑off, oxygen therapy, respiratory tubing, medical device safety, airway devices, ISO 19211, ISO/TC 121, testing, performance criteria.

FAQ

Q: What is this standard?

A: ISO 19211:2024 is an international standard that specifies requirements and test methods for fire‑activated oxygen shut‑off devices used in oxygen therapy tubing. It is intended to ensure devices stop oxygen flow reliably when activated by fire, reducing fire propagation risk.

Q: What does it cover?

A: It covers design, materials, performance limits, testing procedures, verification methods and information/labelling for fire‑activated oxygen shut‑off devices suitable for systems with flows up to 20 l/min. Device‑specific rules override conflicting general airway device requirements.

Q: Who typically uses it?

A: Device manufacturers, conformity assessment and testing laboratories, hospital procurement and biomedical engineering teams, clinical safety officers, and regulators or market surveillance bodies concerned with medical‑gas and fire safety.

Q: Is it current or superseded?

A: ISO 19211:2024 is current (published August 2024). It is the first edition of this device‑specific standard and is not listed as superseded as of its publication. Users should check national and regional adoption (for example EN adoption) for mandated dates and national implementation.

Q: Is it part of a series?

A: It is a device‑specific standard produced by ISO/TC 121/SC 2 (Airway devices and related equipment). It complements general airway device standards such as ISO 18190 and other medical gas and connector standards rather than forming a formal numbered series.

Q: What are the key keywords?

A: Fire‑activated shut‑off, oxygen shut‑off device, oxygen therapy tubing, medical gas safety, airway device testing, ISO 19211.