Overview
EN ISO 17256:2026, developed by CEN and based on ISO 17256:2024, specifies requirements for anaesthetic and respiratory equipment, focusing on respiratory therapy tubing and connectors. This European standard applies to products used to convey respirable gases, such as oxygen, medical air, and breathable gas mixtures to patients in healthcare facilities and homecare settings. It aims to ensure safe and effective connections between the gas supply device and the patient interface, covering both standard and extension tubing. The standard is relevant for manufacturers, clinicians, and stakeholders involved in the design, use, and procurement of respiratory therapy equipment.
Key Topics
- Scope of Application: Includes respiratory tubing and connectors for oxygen, air, oxygen/air mixtures, and other medical gas mixtures such as oxygen/nitrous oxide or oxygen/helium, both in clinical and home environments.
- Connector Types: Defines requirements for inlet and outlet connectors, including elastomeric funnel connectors, R2 small-bore connectors per ISO 80369-2, and gas-specific threaded connectors.
- Safety and Biocompatibility:
- Tubing and connectors must withstand specified mechanical forces and pressures without detachment or leakage.
- Gas pathway materials must comply with ISO 18562-1 for biocompatibility to minimize patient risk.
- Design Requirements: Includes durability assessments, resistance to flow, minimum performance during bending, and leakage limits to maintain safety under diverse conditions.
- Manufacturer Information: Specifies labeling, user instructions, and warning requirements, including notices about the use of fire-activated oxygen shut-off devices.
- Sterility & Packaging: Outlines conditions for devices supplied sterile, referencing packaging and labeling under ISO 18190 and ISO 20417.
- Risk Assessment: Recommends hazard identification and mitigation, addressing potential patient harm such as toxic inhalation, infection, or device occlusion.
Applications
- Clinical Healthcare: Used in hospitals for oxygen and medical gas delivery during respiratory therapy, surgery, and emergency care.
- Homecare: Supports patients requiring long-term oxygen therapy or ongoing respiratory support outside the hospital, addressing the need for reliable and easy-to-use devices for non-clinical users.
- Medical Equipment Manufacturing: Provides benchmarks for product design, materials, and performance, critical for regulatory compliance and market access in the EU and internationally.
- Procurement & Quality Control: Assists healthcare organizations in specifying and evaluating respiratory tubing and connectors to ensure safety, compatibility, and consistent patient care.
Related Standards
- ISO 18190: General requirements for airways and related anaesthetic and respiratory equipment.
- ISO 18562-1: Biocompatibility evaluation for breathing gas pathways in healthcare applications.
- ISO 5367: Specifications for breathing tubes used in breathing systems (excluded from EN ISO 17256:2026βs scope).
- ISO 80369-2: Small-bore connectors for liquids and gases in healthcare.
- EN 13544-2: Preceding standard for respiratory therapy equipment, tubing, and connectors.
- ISO 20417: Information to be supplied by the manufacturer for medical devices.
Implementing EN ISO 17256:2026 ensures enhanced patient safety, compatibility of respiratory therapy components, and streamlined compliance with European and global standards for anaesthetic and respiratory equipment. This standard is essential for anyone involved in the supply, design, or clinical use of respiratory therapy tubing and connectors, supporting best practices in both hospital and homecare environments.
