| ISO 18835 First Edition 2015-04-01 Inhalational Anaesthesia Systems - Draw-over Anaesthetic Systems |
| Recognition Number | Anesthesiology |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 1-114 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Anesthesiology |
| FDA Tech | Neel Patel FDA/OMPT/CDRH/ODE/DAGID/ANDB/ 301-796-6274 Neel.Patel@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| Regulation Number | Device Name | Device Class | Product Code |
| §868.5160 | Gas-Machine, Anesthesia | Class 2 | BSZ |
| Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff, Issued March 2015. |