ISO 5362:2024

Overview

ISO 5362:2024 - "Anaesthetic and respiratory equipment - Anaesthetic reservoir bags" - is the fifth edition International Standard specifying design, performance and information requirements for anaesthetic reservoir bags used in anaesthetic and ventilator breathing systems. It covers neck design, size designation, leakage, elastic resistance and recovery, materials and marking. The standard excludes special-purpose devices (for example, bellows, self‑inflating bags and bags for anaesthetic gas scavenging systems) and gives device‑specific requirements precedence over any conflicting clauses in the general airway standard ISO 18190.

Key topics and technical requirements

• Designated size: Bags must be labelled by capacity; designated size shall be within ±15% of nominal volume (litres or millilitres). (Annex C)
• Leakage: Under internal pressure of (3 ± 0.3) kPa, allowable leakage is ≤ 10 ml/min for sizes ≤1 L and ≤ 25 ml/min for sizes >1 L. (Annex B)
• Necks and adaptors:
  • Bags may have plain necks or assembled necks with adaptors compatible with ISO 5356-1 22 mm conical connectors.
  • Plain necks: minimum axial length 26 mm (unstretched).
  • Attachment security: necks/adaptors shall not detach under an axial force of (40 ± 4) N (tests in Annex D and E).
• Tails: If open and not closable, tails must be at least 20 mm long and located opposite the neck.
• Elastic resistance & recovery:
  • When subjected to a constant airflow equal to 2× the designated size per minute for 120 ± 2 s, internal pressure shall be between 3.0 kPa and 6.0 kPa (Annex F).
  • Bags must recover to within 10% of designated size within 30 minutes after testing.
• Materials & biocompatibility: Breathing gas pathways require biocompatibility assessment per ISO 18562‑1; material recommendations appear in Annex G.
• Information & marking: Manufacturer information requirements reference ISO 20417 and ISO 18190; bags must be marked with the designated size and applicable product information.

Applications and who uses this standard

• Manufacturers and designers of anaesthetic reservoir bags - for design, materials selection and production testing.
• Quality / regulatory teams - to develop compliance and conformity assessment evidence.
• Clinical engineers and procurement - to specify and select compatible, tested reservoir bags for anaesthesia and ventilator systems.
• Test laboratories - for performing leakage, attachment and elastic resistance tests described in the normative annexes.
• Risk managers - for hazard identification and biocompatibility evaluation within device risk management.

Related standards

• ISO 18190 - General requirements for airways and related equipment (device-wide requirements referenced).
• ISO 5356‑1 - Conical connectors (22 mm cone/socket compatibility).
• ISO 18562‑1 - Biocompatibility evaluation of breathing gas pathways.
• ISO 20417 - Information supplied by the manufacturer.

ISO 5362:2024 is essential when specifying, testing or certifying anaesthetic reservoir bags to ensure mechanical compatibility, controlled leakage and predictable elastic behaviour in anaesthetic and respiratory equipment.