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PS 3645-2025

Active
Anaesthetic and respiratory equipment – Anaesthetic reservoir bags
Committee: Medical Devices and Supplies
Sector: Health and Personal Care
Available Standards
Original Standard
إنجليزي (English) 23 Page 2025
International Classification for Standards (ICS)
Code Classification
11.040.10 Anaesthetic, respiratory and reanimation equipment
Adopted Standards
Standards / Amendment / Corrigendum
1 ISO 5362:2024
Replacement Sequence
Scope

This document specifies requirements for anaesthetic reservoir bags for use with anaesthetic and ventilator breathing systems. It includes requirements for the design of the neck, size designation and elasticity.
This document is not applicable to special-purpose bags, for example bellows, self-inflating bags and bags for use with anaesthetic gas scavenging systems.
The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190). All the common requirements that appear in the general standard for airway devices have been removed from this document.