| ISO 8835-7 First edition 2011-11-01 Inhalational anaesthesia systems - Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases |
| Recognition Date | 2017-08-21 |
| Recognition List | 047 |
| Recognition Number | 1-124 |
| 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 8835-7:2011 specifies safety and performance requirements for anaesthetic systems and components that:
- can function in the absence of a supply of compressed medical gases or mains electricity;
- can withstand a challenging environment, including high temperatures, humidity, shocks and vibration, and dust;
- allow local servicing and maintenance;
- may be suitable for use with flammable anaesthetic agents.
| 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, March 2015 |