Name: ISO 17256:2024 — Anaesthetic and respiratory equipment — Respiratory therapy tubing and connectors
SKU: ISO 17256:2024
Price: 25 EUR
Availability: InStock

Abstract

Overview

ISO 17256:2024 - Anaesthetic and respiratory equipment - Respiratory therapy tubing and connectors (First edition 2024) defines safety and performance requirements for respiratory tubing, extension tubing and connectors used to convey respirable gases (primarily oxygen, air or breathable medicinal gas mixtures) in healthcare and homecare environments. The standard focuses on secure connections between gas supply devices and patient interfaces, reducing the risk of misconnection and ensuring reliable oxygen delivery outside of anaesthetic machines and ventilators.

Key topics and technical requirements

ISO 17256:2024 builds on ISO 18190 and includes device-specific mandates. Key technical points include:

Connector design and interchangeability
- Outlet connector: adoption of the R2 respiratory small-bore connector for patient-end outlets when tubing is not integrated with the patient interface to reduce misconnections.
- Inlet connector: compatible with the EN 13544-2 style elastomeric (funnel) connector or optional gas-specific threaded inlet connectors.
Mechanical strength and attachment
- Tubing and extension tubing must withstand an axial force of (40 ± 1,5) N; connectors shall be permanently attached (not removable without a tool).
- Integrated tubing must not detach from a patient interface under the same axial force.
Retention and leakage
- Elastomeric funnel connectors shall resist detachment at 200 ± 10 kPa when tested on a defined test nipple.
- Total leakage (including connectors) limited to ≤ 5 ml/min at 600 ± 10 kPa internal pressure.
Flow performance
- Resistance to flow must be ≤ 0.9 kPa/m at 4 l/min.
- Bending test: flow must not reduce by more than 25% when tubing is bent to a semicircle of diameter three times nominal outside diameter.
Materials and biocompatibility
- Gas pathway materials require biological assessment per ISO 18562-1; manufacturers must provide documentation demonstrating conformance.
Test conditions
- Type tests performed at (23 ± 2) °C and atmospheric pressure; flow/volume rates expressed STPD.

Applications and who uses this standard

ISO 17256:2024 is essential for:

Manufacturers of respiratory tubing, connectors, nasal cannulae, masks and extension tubing - for product design, testing and regulatory submission.
Medical device test laboratories - to perform mechanical, leakage and flow tests.
Clinical engineers and procurement teams - to specify safe, compatible tubing for hospitals, clinics and homecare settings.
Regulatory bodies and conformity assessors - to verify compliance and reduce misconnection risks in patient gas delivery systems.

Keywords: ISO 17256:2024, respiratory tubing, connectors, respiratory therapy, extension tubing, R2 connector, elastomeric funnel, biocompatibility, oxygen delivery, misconnection prevention.

Related standards

ISO 18190 - General requirements for airways and related equipment
ISO 18562-1 - Biocompatibility evaluation of breathing gas pathways
ISO 80369-2 - Respiratory small-bore connectors
ISO 5367 - Breathing tubes for breathing systems (excluded from ISO 17256 scope)
ISO 4135, ISO 20417, ISO 21920-1 (referenced for terminology, labeling and surface texture)

ISO 17256:2024 PDF

Похожие стандарты

Abstract

Overview

Key topics and technical requirements

Applications and who uses this standard

Related standards

Технические детали

BS ISO 18190:2025-TC

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

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…

SIST EN ISO 5367:2023

Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2023)

BS EN ISO 17256:2026

Anaesthetic and respiratory equipment. Respiratory therapy tubing and connectors.

ISO 4135:2022

Anaesthetic and respiratory equipment — Vocabulary

EN ISO 20417:2026

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2026)

SIST EN ISO 21920-1:2022

Geometrical product specifications (GPS) - Surface texture: Profile - Part 1: Indication of surface texture (…