ISO 5361-2023 PDF

Full title and description

St ISO 5361-2023 — Anaesthetic and respiratory equipment — Tracheal tubes and connectors. This International Standard specifies safety and performance requirements for oro‑tracheal and naso‑tracheal tubes and tracheal tube connectors, including a range of specialized tracheal tube types (reinforced walls, tapered tubes, tubes with shoulders, and tubes with means for suctioning, monitoring or delivery of drugs or other gases).

Abstract

ISO 5361:2023 defines essential performance and basic safety requirements for tracheal tubes and their connectors used in anaesthetic and respiratory care. The document covers design, materials, marking, dimensional and mechanical requirements, tests (including leakage and strength), biocompatibility considerations, and packaging/sterilization aspects for the covered tube types while excluding tracheostomy tubes, tracheobronchial/endobronchial tubes and supralaryngeal airways.

General information

• Status: Published.
• Publication date: January 2023 (edition 4; corrected versions issued November 2023).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.10 — Anaesthetic and respiratory equipment.
• Edition / version: Edition 4 (2023).
• Number of pages: 45 pages (official published document).

Scope

This standard applies to oro‑tracheal and naso‑tracheal tubes and tracheal tube connectors and covers a broad range of tube designs used in anaesthetic and respiratory practice (including reinforced‑wall tubes, tapered and shouldered tubes, and tubes with additional lumens or ports for suctioning, monitoring or drug/gas delivery). It explicitly excludes tracheostomy tubes, tracheobronchial/endobronchial tubes and supralaryngeal airways, and it does not cover tracheal tubes intended for use with flammable anaesthetic agents, laser or electrosurgical applications.

Key topics and requirements

• Essential performance and basic safety criteria for tracheal tubes and connectors (dimensional, mechanical and functional requirements).
• Marking and labelling requirements (identification of type, size, manufacturer, batch/lot and sterility/expiry information).
• Material and biocompatibility considerations for patient-contacting components.
• Requirements and tests for cuffs (where applicable), leak tightness, connector fit and mechanical strength.
• Packaging, sterilization and storage conditions to preserve sterility and function.
• Exclusions and normative references to related airway and airway‑safety standards (for laser use, tracheostomy devices, endobronchial tubes, etc.).

Typical use and users

Used by manufacturers and test laboratories to design, verify and certify tracheal tubes and connectors for clinical use; by regulatory bodies reviewing device conformity; and by procurement, clinical engineering and anaesthesia/respiratory departments for product selection and quality assurance. Typical users include medical device manufacturers, conformity assessment bodies, hospital procurement teams and clinical clinicians involved in airway management.

Related standards

Standards commonly referenced alongside ISO 5361:2023 include ISO 5366 (tracheostomy tubes), ISO 16628 (endobronchial/tracheobronchial tubes), ISO 11712 (supralaryngeal airways), and standards addressing laser airway procedures (ISO 11990‑1, ISO 11990‑2) and related safety requirements such as ISO 14408. National/adopted variants (e.g., UNE‑EN ISO 5361:2023) may also exist.

Keywords

tracheal tube; tracheal connector; endotracheal tube; anaesthetic equipment; respiratory equipment; airway device; cuffed tube; uncuffed tube; connector dimensions; biocompatibility; leakage test; ISO 5361:2023.

FAQ

Q: What is this standard?

A: ISO 5361:2023 is an International Standard specifying safety and performance requirements for oro‑tracheal and naso‑tracheal tubes and tracheal tube connectors used in anaesthesia and respiratory care.

Q: What does it cover?

A: It covers design, material, marking, dimensional and mechanical requirements, testing (leakage, strength), packaging and sterilization for the covered tracheal tube types, and lists exclusions such as tracheostomy and tracheobronchial tubes and devices intended for laser or electrosurgical environments.

Q: Who typically uses it?

A: Medical device manufacturers, testing and certification bodies, regulators, clinical engineers, procurement teams and clinicians working in anaesthesia and respiratory therapy use this standard for product development, conformity assessment and safe clinical use.

Q: Is it current or superseded?

A: ISO 5361:2023 (edition 4) is the current published version (published January 2023) and replaces earlier editions (including the 2016 and 2012 versions). Corrected versions were issued in November 2023.

Q: Is it part of a series?

A: Yes — ISO 5361 has a history of earlier parts/editions and is related to other airway device standards (for example, ISO 5366 for tracheostomy tubes and ISO 16628 for endobronchial devices). It sits within the portfolio of standards developed by ISO/TC 121 (Anaesthetic and respiratory equipment).

Q: What are the key keywords?

A: Tracheal tube, tracheal connector, endotracheal tube, airway device, anaesthetic equipment, connector dimensions, cuff, biocompatibility, leakage test, ISO 5361:2023.