Overview
ISO 5367:2023 - Anaesthetic and respiratory equipment - Breathing sets and connectors specifies minimum safety and performance requirements for breathing sets, breathing tubes and patient‑end adaptors used with anaesthetic systems, ventilators, humidifiers and nebulizers. The sixth edition covers both single‑use and reusable assemblies, includes provisions for coaxial, bifurcated, double‑lumen and multiple‑lumen tubing, and addresses special components such as water traps and neonatal connections.
Key topics and technical requirements
- Scope and applicability: Requirements for assembled breathing sets and components supplied for manufacturer assembly; not intended for devices with special, non‑standard ventilator interfaces.
- Materials and biological safety: Materials must meet biocompatibility and ISO 18562‑1 evaluation requirements.
- Design requirements:
- Designated length: Nominal overall length declared for resting and extended tubes; actual length tolerance ±10%.
- Breathing tube ends: Plain ends and assembled ends are defined; axial lengths and secure attachment specified.
- Connector integrity: Adaptors must conform to ISO 5356‑1 sockets/cones; assembled adaptors must resist axial detachment (≥45 N for 15 mm and 22 mm, ≥30 N for 11.5 mm).
- Patient connection ports: Typical patient ports include coaxial 22 mm cone/15 mm socket or 15 mm socket.
- Performance tests and limits: Normative test methods are provided in annexes for leakage, resistance to flow, compliance, axial strength, and increase in flow resistance with bending (Annexes C–H).
- Packaging, sterilization & labeling: Requirements for sterile supply, packaging integrity, and manufacturer information (marking and instructions for use) are specified.
- Recommended service life: Reusable sets must meet requirements throughout the declared service life.
Practical applications - who uses this standard
- Manufacturers and designers of breathing sets and connectors use ISO 5367:2023 to design, test and declare product performance and safety.
- Test laboratories and conformity assessors apply the annexed test methods to verify leakage, flow resistance and mechanical strength.
- Clinical engineers and procurement teams rely on declared values (length, resistance, connector compatibility) to select compatible tubing for anaesthesia and ICU ventilators.
- Regulators and notified bodies refer to this standard during device evaluation and conformity assessment.
- Hospitals and respiratory therapists benefit indirectly through safer, interoperable breathing sets and clearer labeling for use with ventilators, humidifiers and nebulizers.
Related standards
- ISO 18190:2016 - General requirements for airways and related equipment
- ISO 5356‑1 - Conical connectors (cones and sockets)
- ISO 4135 - Vocabulary for anaesthetic and respiratory equipment
- ISO 18562‑1 - Biocompatibility evaluation of breathing system materials
ISO 5367:2023 is essential for ensuring safe, interoperable breathing circuits and connectors across anaesthetic and respiratory care environments.
