ISO 5362-2024 PDF

Full title and description

ISO 5362:2024 — Anaesthetic and respiratory equipment — Anaesthetic reservoir bags. Specifies requirements for single‑use and reusable anaesthetic reservoir bags intended for use with anaesthetic and ventilator breathing systems, including neck design, size designation and elasticity; excludes special‑purpose bags such as bellows, self‑inflating bags and bags for scavenging systems.

Abstract

This International Standard sets device‑specific requirements for anaesthetic reservoir bags (materials, dimensions, marking and functional characteristics such as distension/elasticity and neck design). The device‑specific requirements take precedence over any conflicting requirements in the general airway devices standard (ISO 18190).

General information

• Status: Published (International Standard).
• Publication date: July 2024 (published July 2024 / edition 5).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.10 — Anaesthetic, respiratory and reanimation equipment.
• Edition / version: Edition 5 (2024).
• Number of pages: 15 pages (main published text).

Scope

ISO 5362:2024 applies to anaesthetic reservoir bags (single‑use and reusable) for use with anaesthetic and ventilator breathing systems. It covers geometric and design requirements (notably neck design and size designation), functional requirements such as elasticity/distension, and marking. It explicitly excludes special‑purpose bags (for example bellows, self‑inflating bags) and bags intended for anaesthetic gas scavenging systems. Device‑specific requirements in ISO 5362 take precedence over conflicting clauses in the general airway devices standard.

Key topics and requirements

• Design and dimensions of the bag neck and machine/patient connections (to ensure compatible fit and safe attachment).
• Size designation system and marking (clear size labelling to support clinical selection and interchangeability).
• Elasticity / distension and performance requirements (tests and limits for expansion, recoil and functional behaviour).
• Specification for single‑use and reusable bags, including intended product life and applicable test methods.
• Requirement that device‑specific clauses override general airway requirements (relationship with ISO 18190).
• Exclusions and non‑applicability (bellows, self‑inflating bags, scavenging system bags).

Typical use and users

Primary users are manufacturers and designers of anaesthesia and ventilator breathing systems, regulatory/standards compliance teams, test laboratories performing device verification, procurement specialists in hospitals, and clinical engineers responsible for equipment selection and maintenance. The standard supports product specification, design validation and regulatory documentation.

Related standards

Key related documents include ISO 18190 (general requirements for airway devices and related equipment — device‑level general requirements), ISO 5367 (breathing sets and connectors), ISO 5364 (oropharyngeal airways) and ISO 5366 (tracheostomy tubes and connectors); all are maintained by ISO/TC 121/SC 2 and form the broader family of anaesthetic and respiratory equipment standards.

Keywords

anaesthetic reservoir bag; anaesthesia; breathing system; ventilator; size designation; neck design; elasticity; distension; single‑use; reusable; ISO 5362.

FAQ

Q: What is this standard?

A: ISO 5362:2024 is an International Standard that specifies requirements for anaesthetic reservoir bags used with anaesthetic and ventilator breathing systems (Edition 5, published July 2024).

Q: What does it cover?

A: It covers design and dimensional requirements (notably the neck), size designation and marking, elasticity/distension performance and distinctions for single‑use and reusable bags; it excludes special‑purpose bags such as bellows, self‑inflating bags and scavenging system bags.

Q: Who typically uses it?

A: Manufacturers, test laboratories, clinical engineering and procurement teams, regulatory affairs professionals and standards bodies use ISO 5362 to set product specifications, run conformity testing and support regulatory submissions.

Q: Is it current or superseded?

A: ISO 5362:2024 is the current published edition (Edition 5, 2024). It supersedes earlier editions such as ISO 5362:2006 (and prior versions).

Q: Is it part of a series?

A: Yes — it is part of the ISO family of anaesthetic and respiratory equipment standards maintained by ISO/TC 121/SC 2 (e.g., ISO 18190, ISO 5367, ISO 5364, ISO 5366), which together cover airway devices, breathing sets, connectors and related components.

Q: What are the key keywords?

A: anaesthetic reservoir bag; breathing system; size designation; neck design; elasticity; single‑use; reusable; ISO 5362.