ISO 18835:2015 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.
ISO 18835:2015 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.
ISO 18835:2015 does not specify requirements for monitoring of the equipment or the patient.