Recognized standard
80601-2-13 Second edition 2022-04
FDA recognition 1-165 · ISO · Anesthesiology
Key facts
| Recognition number | 1-165 |
|---|---|
| Designation | 80601-2-13 Second edition 2022-04 |
| Title | Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Dec 18, 2023 |
| Device classes | Class 2 |
| Scope (excerpt) | This document is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator. This document specifies particular requirements for a complete anaesthetic workstation and the… |
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: