Overview
EN ISO 5367:2023 (ISO 5367:2023) is the current European/International standard for anaesthetic and respiratory equipment dealing specifically with breathing sets, breathing tubes and connectors. Published in 2023 and adopted by CEN, it defines minimum safety, design and performance requirements for breathing sets used with anaesthetic breathing systems, ventilator breathing systems, humidifiers and nebulizers. The standard covers assemblies supplied pre‑assembled or supplied as components to be assembled per the manufacturer’s instructions, and includes coaxial, bifurcated, double‑lumen and multiple‑lumen configurations as well as neonatal provisions.
Key topics and technical requirements
- Scope and applicability: Single‑use and reusable breathing sets; assemblies with special components (e.g., water traps); exclusion of devices intended only for special, non‑standard clinical purposes.
- General requirements: Reference to ISO 18190 format; recommended service life considerations for reusable products.
- Materials & biological safety: Requirements for material selection and biological safety testing.
- Design requirements:
- Designated length and connector/end types (patient end adaptors, machine end).
- Leakage limits and methods for leakage testing.
- Resistance to flow, compliance, and axial strength of tubes.
- Security of attachment for plain and assembled ends.
- Sterility, packaging and labelling: Requirements for breathing sets supplied sterile, packaging integrity and required markings.
- Information supplied by the manufacturer: Instructions for use, conformity and performance data (e.g., flow resistance).
- Test methods and annexes: Normative test procedures for attachment security, leakage, flow resistance, bending effects and compliance (Annexes C–H). Some tests use constant pressure for practical test methodology.
Practical applications
- Ensures breathing sets and connectors perform safely with anaesthesia machines, mechanical ventilators, humidifiers and nebulizers.
- Enables consistent design and testing during product development, validation and quality control.
- Provides procurement criteria for hospitals and clinical engineering when selecting breathing sets (single‑use vs reusable).
- Supports regulatory compliance, risk management and lab testing requirements.
Who uses this standard
- Medical device manufacturers of breathing sets, breathing tubes and connectors
- Quality, design and regulatory engineers in ventilator and anaesthesia equipment firms
- Test laboratories and conformity assessment bodies
- Hospital procurement, clinical engineering and infection control teams
Related standards
Keywords: EN ISO 5367:2023, ISO 5367:2023, breathing sets, breathing tubes, anaesthetic and respiratory equipment, connectors, ventilator breathing systems, leakage, flow resistance, compliance.