ISO 23368:2022 PDF

Name: ISO 23368:2022 — Anaesthetic and respiratory equipment — Low-flow nasal cannulae for oxygen therapy
SKU: ISO 23368:2022
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Anaesthetic and respiratory equipment — Low-flow nasal cannulae for oxygen therapy

Название (английский):

ISO 23368:2022

Anaesthetic and respiratory equipment — Low-flow nasal cannulae for oxygen therapy

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 9
Дата публикации:: 29 июля 2022 г.
Издание:: ISO IS 23368 edition 1 version 1
ICS:: 11.040.10

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Описание (английский):

This document specifies requirements for low-flow nasal cannulae, used in both home care and hospital environments for the administration of oxygen therapy. This document does not include requirements to prevent the proliferation of fire within the tubing but does specify a user-detachable connection that can be used to fit a fire-activated oxygen shut-off device.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 23368:2022 - "Anaesthetic and respiratory equipment - Low-flow nasal cannulae for oxygen therapy" specifies safety, design and performance requirements for low-flow nasal cannulae used in home care and hospital settings. It covers device definition (flows ≤6 l/min), materials, biological safety of gas pathways, sterility, packaging and required information from manufacturers. The standard does not mandate fire-propagation prevention in tubing but requires a user‑detachable connection that can accept a fire‑activated oxygen shut‑off device.

Key topics and technical requirements

Definition and scope

Low‑flow nasal cannulae designed for oxygen therapy (≤6 l/min); devices must operate normally up to 15 l/min.

Materials and biocompatibility

Gas pathways must be assessed for biological safety per ISO 18562‑1.

Design and layout

Cannulae can be integral with therapy tubing (minimum 1.8 m) or user‑detachable with an inlet connector within 100 mm of the bifurcation (or within 500 mm if not bifurcated).

Inlet connector

User‑detachable inlet connectors must use an R2 respiratory small‑bore socket connector complying with ISO 80369‑2 to reduce misconnection risk.
Integral inlet connectors must withstand an internal static pressure test of (200 ± 10) kPa for 30 s on a specified test nipple.

Flow resistance and performance

Therapy tubing resistance: ≤ 0.9 kPa/m at specified flows (4 l/min adult, 3 l/min paediatric, 2 l/min neonatal).
Headset resistance: ≤ 10 kPa at the same flows.
Flow reduction on semicircular bend must be ≤ 25% (Annex A test methods).

Mechanical security

Connectors must resist static axial disconnection force (40 ± 1.5) N; nasal prongs must resist (50 ± 1.5) N (Annex B).

Sterility, packaging, manufacturer information

Requirements referenced to ISO 18190 for sterility, packaging and labeling expectations.

Applications and users

Manufacturers and designers of oxygen therapy interfaces (product development and compliance).

Regulatory and quality teams verifying conformity for market access.

Test laboratories conducting resistance, pressure and pull‑off testing using Annex A/B methods.

Healthcare procurement, clinical engineers and respiratory therapists evaluating device compatibility and safety for home care and hospital oxygen therapy.

Risk managers implementing fire‑safety measures (via compatible user‑detachable connectors for oxygen shut‑off devices).

Related standards

ISO 18190 - General requirements for airways and related equipment

ISO 18562‑1 - Biocompatibility evaluation of breathing gas pathways

ISO 80369‑2 - Small‑bore connectors for respiratory applications

ISO 4135 - Vocabulary for anaesthetic and respiratory equipment

Keywords: ISO 23368:2022, low‑flow nasal cannulae, oxygen therapy, home care oxygen, inlet connector, resistance to flow, R2 connector, ISO 80369‑2, biocompatibility.

ISO 23368:2022 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and users

Related standards

Технические детали

SIST EN ISO 18562-1:2024

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and tes…

SIST EN ISO 80369-20:2025

Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80…

BS ISO 18190:2025-TC

Tracked Changes. Anaesthetic and respiratory equipment. General requirements for airway devices and related e…

ISO 4135:2022

Anaesthetic and respiratory equipment — Vocabulary