Overview
EN ISO 5362:2024 - Anaesthetic and respiratory equipment - Anaesthetic reservoir bags (ISO 5362:2024) specifies device‑specific requirements for anaesthetic reservoir bags used in anaesthetic and ventilator breathing systems. The standard focuses on the design of the neck, size designation, elasticity, and functional integrity (leakage and attachment security). It replaces EN ISO 5362:2019 and was published/endorsed in 2024 by CEN in alignment with ISO.
Key topics and technical requirements
- Scope and applicability
- Applies to collapsible, distensible anaesthetic reservoir bags used in breathing systems.
- Not applicable to special‑purpose bags such as bellows, self‑inflating bags, or bags for anaesthetic gas scavenging systems.
- Design of necks and connectors
- Defines plain necks (fit directly over ISO 5356‑1 conical cone connectors) and assembled necks (incorporating adaptors).
- Includes tests for security of attachment of necks and adaptors to 22 mm cone connectors.
- Size designation
- Specifies methods for determining the designated size of reservoir bags (normative procedures included).
- Elasticity and mechanical performance
- Requirements and normative tests for elastic resistance and elastic recovery (Annex F).
- Pressure/distension testing uses air as the normative test medium (water method removed in this edition).
- Leakage and integrity
- Normative air leakage test procedures are specified (Annex B).
- Materials and biocompatibility
- General materials guidance and recommendations (Annex G) and reference to breathing‑gas pathway biocompatibility evaluation (ISO 18562‑1).
- Marking, information and packaging
- Manufacturer information requirements and marking follow the standard and ISO 20417 guidance.
- Risk and rationale
- Informative annexes provide rationale and hazard identification to support risk assessment (Annex A, H).
Applications - who uses this standard
- Manufacturers designing and producing anaesthetic reservoir bags and neck adaptors.
- Clinical engineers and procurement teams specifying compliant breathing system components.
- Regulatory affairs and QA for conformity assessment, product documentation, and CE/national compliance.
- Design and test laboratories performing leakage, attachment and elasticity testing per the normative annexes.
- Standards and safety officers conducting risk assessments and materials selection for respiratory device lines.
Related standards
- ISO 18190 - General requirements for airways and related equipment (note: device‑specific requirements in ISO 5362 take precedence where they conflict)
- ISO 5356‑1 - Conical connectors (cones and sockets)
- ISO 18562‑1 - Biocompatibility evaluation of breathing gas pathways
- ISO 20417 - Information supplied by the manufacturer
EN ISO 5362:2024 is essential for ensuring the functional safety, interchangeability and regulatory compliance of anaesthetic reservoir bags used in modern anaesthetic and ventilator breathing systems.
