SIST EN ISO 23368:2022 PDF

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

Название (английский):

SIST EN ISO 23368:2022

Anaesthetic and respiratory equipment - Low-flow nasal cannulae for oxygen therapy (ISO 23368:2022)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 17
Дата публикации:: 11 октября 2022 г.
ICS:: 11.040.10
Технический комитет:: VAZ - Healthcare

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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

EN ISO 23368:2022 - Anaesthetic and respiratory equipment: Low‑flow nasal cannulae for oxygen therapy - specifies design, safety and performance requirements for low‑flow nasal cannulae used in home care and hospital settings. The standard defines low‑flow cannulae as patient interfaces designed for use with flows ≤ 6 L/min and requires devices to operate normally up to 15 L/min. It does not set requirements to prevent fire propagation in tubing, but it requires a user‑detachable connection to allow fitting of a fire‑activated oxygen shut‑off device.

Key topics and technical requirements

Scope and definitions

Applies to low‑flow nasal cannulae (adult, paediatric, neonatal) used for oxygen therapy.
Defines inlet connector, integral vs user‑detachable cannulae, and oxygen therapy terms.

Materials and biological safety

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

Design requirements

Cannulae may be integral with therapy tubing (min. length 1.8 m) or user‑detachable with inlet connector located close to the bifurcation.
Operation specified for flows ≤15 L/min.

Flow and resistance

Therapy tubing resistance: ≤ 0.9 kPa/m at 4 L/min (adult), 3 L/min (paediatric), 2 L/min (neonatal).
Headset resistance: ≤ 10 kPa at the same respective flows.
Bending test: flow reduction must not exceed 25% when tubing is bent into a semicircle with diameter three times its smallest outside diameter.

Connectors and mechanical tests

Inlet connectors for integral cannulae must be compatible with specified nipple profile and resist detachment under a static internal pressure of (200 ± 10) kPa. Specified engagement forces and torques are used in testing.

Sterility, packaging and information

Requirements cover sterility claims, packaging and mandatory manufacturer information supplied with the device.

Applications and who uses this standard

Manufacturers and product designers of nasal cannulae and oxygen therapy tubing - for design, testing and technical documentation.

Medical device testing laboratories - to verify resistance‑to‑flow, connector security and bending performance per normative test methods (Annex A/B).

Procurement and clinical engineering in hospitals and home‑care services - to specify compliant equipment.

Regulatory bodies and conformity assessors - to assess conformity with European and international requirements for respiratory patient interfaces.

Related standards

ISO 4135 (vocabulary), ISO 18190 (general airway requirements), ISO 18562‑1 (biocompatibility of breathing gas pathways), ISO 80369‑2 (small‑bore connectors for respiratory applications).

Keywords: EN ISO 23368:2022, low‑flow nasal cannulae, oxygen therapy, nasal cannula, resistance to flow, user‑detachable connection, home care, hospital.

SIST EN ISO 23368:2022 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and who uses this standard

Related standards

Технические детали

ISO 23368:2022

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

SIST EN ISO 18562-1:2024

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

ISO 4135:2022

Anaesthetic and respiratory equipment — Vocabulary

BS ISO 18190:2025-TC

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

SIST EN ISO 80369-20:2025

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