ISO 5367-2023 PDF

Full title and description

ISO 5367:2023 — Anaesthetic and respiratory equipment — Breathing sets and connectors. This international standard specifies minimum requirements for breathing sets, breathing tubes and patient‑end adaptors intended for use with anaesthetic breathing systems, ventilator breathing systems, humidifiers and nebulizers; it covers pre‑assembled assemblies and component sets supplied for assembly in accordance with the manufacturer’s instructions.

Abstract

This document defines design, material, marking and performance requirements and associated test methods for breathing sets and breathing tubes (including coaxial, bifurcated, double‑lumen and multiple‑lumen types) and for patient‑end adaptors. It is applicable to assemblies that include special components (for example water traps) and provides limits and test procedures for leakage, resistance to flow, compliance, axial strength and connector integrity to ensure safe respiratory and anaesthetic support.

General information

• Status: Published.
• Publication date: 14 July 2023 (Edition 6 published).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.10 — Anaesthetic, respiratory and reanimation equipment.
• Edition / version: Edition 6 (2023).
• Number of pages: 27 pages (ISO official publication).

Scope

ISO 5367:2023 applies to breathing sets and breathing tubes and patient end adaptors supplied either already assembled or as components to be assembled by the manufacturer or following manufacturer instructions. It covers designs intended for anaesthesia and ventilatory support (including humidifiers and nebulizers), and includes provisions for coaxial, bifurcated, double‑lumen and multi‑lumen sets and for assemblies that include special components (for example water traps). The standard excludes breathing sets designed only for special non‑standard ventilatory applications (for example some HFOV/HFJV or ventilators with unusual compliance/pressure/frequency requirements).

Key topics and requirements

• Materials and biocompatibility: requirement to address materials safety and evaluation in line with medical‑device biocompatibility practices (cross‑references to ISO 18562 series where applicable).
• Connector and adaptor conformity: patient and machine connectors/adaptors are required to conform to the appropriate conical connector dimensions and interfaces (e.g., ISO 5356‑1 style cones/sockets) and meet axial‑strength requirements (typical axial pull‑off minima specified for common diameters — e.g., values on the order of tens of newtons for 15 mm / 22 mm and lower values for smaller connectors where specified).
• Leakage limits and categorization by patient size: normative leakage limits and test procedures are given by patient category (adult, paediatric, neonatal) with specific maximum leakage figures and test pressures for each category to ensure safe ventilation performance.
• Resistance to flow and compliance: the standard specifies maximum allowed resistance per metre for cut‑to‑length tubing and maximum resistance / compliance limits for ready‑to‑use breathing sets, reported by patient category; manufacturers must determine, mark and declare resistance and compliance values as required by the standard and perform specified test methods (annexes provide test procedures).
• Mechanical performance and durability tests: axial strength, bending and suspension tests, and tests for increase in resistance with bending are specified; normative test methods and acceptance limits are provided in the annexes.
• Marking, labelling and information: requirements for product identification, declared dimensions/lengths, intended patient category, resistance/compliance values, warnings and assembly instructions are specified to support safe selection and use.
• Test methods and normative annexes: the standard contains normative annexes that describe test setups and acceptance criteria for leakage, resistance, compliance, axial strength and other characteristic tests.

Typical use and users

Primary users are medical device manufacturers (design and regulatory teams), quality and compliance engineers, clinical engineers, procurement specialists in hospitals, testing laboratories and regulatory authorities. Clinicians (anesthetists, respiratory therapists) and biomedical engineers consult the standard for correct selection, marking interpretation and safe clinical use. The document supports design, verification and labelling of single‑use and reusable breathing sets used across adult, paediatric and neonatal care.

Related standards

Key related standards referenced by or commonly used with ISO 5367: ISO 5356‑1 (conical connectors — cones and sockets), ISO 18190 (general requirements for airways and related equipment), ISO 18562 (biocompatibility of breathing gas pathways), ISO 80601‑2‑12 and ISO 80601‑2‑13 (ventilator particular requirements) and other regional/adopted versions (EN ISO 5367). An amendment work item for ISO 5367:2023 (Amendment 1) is also registered/under development.

Keywords

breathing set, breathing tube, patient connector, anaesthetic equipment, ventilator accessory, connector, conical cone, leakage limit, resistance to flow, compliance, neonatal, paediatric, ISO 5367

FAQ

Q: What is this standard?

A: ISO 5367:2023 is the sixth edition (published 14 July 2023) of the international standard that sets minimum safety, design and test requirements for breathing sets, breathing tubes and related connectors used in anaesthesia and respiratory support.

Q: What does it cover?

A: It covers design and material considerations, marking and information, mechanical and performance tests (leakage, resistance, compliance, axial strength), connector interface requirements and specific labelling/declared values by patient category (adult, paediatric, neonatal). It applies to pre‑assembled assemblies and component sets supplied for assembly in accordance with manufacturer instructions and excludes special‑purpose breathing sets for non‑standard ventilator modalities.

Q: Who typically uses it?

A: Manufacturers, test laboratories, clinical engineers, procurement and regulatory bodies use ISO 5367 to design, verify and purchase compliant breathing sets; clinicians reference the declared performance values for safe device selection.

Q: Is it current or superseded?

A: Current — ISO 5367:2023 (Edition 6) supersedes ISO 5367:2014. The 2023 edition is the published, active international standard; an amendment (ISO 5367:2023/AWI Amd 1) has been registered as a work item.

Q: Is it part of a series?

A: It is part of a family of ISO standards for anaesthetic and respiratory equipment and is commonly used alongside ISO 5356‑1, ISO 18190, ISO 18562 and ventilator‑specific standards (e.g., ISO 80601‑2‑12 / ‑13) to address interfaces, biocompatibility and device‑specific performance.

Q: What are the key keywords?

A: breathing set, breathing tube, connector, anaesthesia, ventilator, leakage, resistance, compliance, patient categories (adult/pediatric/neonatal), ISO 5367.