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PS 3681-2025
Active
Inhalational anaesthesia systems — Draw-over anaesthetic systems
Committee:
Medical Devices and Supplies
Sector:
Health and Personal Care
Available Standards
Original Standard
إنجليزي (English)
32
Page
2025
International Classification for Standards (ICS)
| Code | Classification |
|---|---|
| 11.040.10 | Anaesthetic, respiratory and reanimation equipment |
Adopted Standards
| Standards / Amendment / Corrigendum | |
|---|---|
| 1 | ISO 18835:2015 |
Replacement Sequence
| Replaces |
|---|
| PS 3681-2018 |
Scope
This International Standard specifies basic safety and essential performance requirements for
anaesthetic systems utilizing the draw-over method to provide inhalational anaesthesia.
Requirements are included to allow the use of these systems with both non-flammable and flammable
anaesthetic agents.
This International Standard also includes requirements for a bellows-type manual ventilator.
NOTE 1 Requirements for automatic anaesthetic ventilators are covered by ISO 80601-2-13.
NOTE 2 Requirements for operator-powered self-inflating bags are covered by ISO 10651-4.
This International Standard does not specify requirements for monitoring of the equipment or the patient.