Recognized standard
8835-7 First edition 2011-11-01
FDA recognition 1-124 · ISO · Anesthesiology
Key facts
| Recognition number | 1-124 |
|---|---|
| Designation | 8835-7 First edition 2011-11-01 |
| Title | Inhalational anaesthesia systems - Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Aug 21, 2017 |
| Device classes | Class 2 |
| Scope (excerpt) | 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… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: