Recognized standard
80601-2-12 Third edition 2023-11
FDA recognition 1-187 · ISO · Anesthesiology
Key facts
| Recognition number | 1-187 |
|---|---|
| Designation | 80601-2-12 Third edition 2023-11 |
| Title | Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Dec 23, 2024 |
| Device classes | Class 2 |
| Scope (excerpt) | This document applies to the basic safety and essential performance of a critical care ventilator in combination with its accessories, hereafter referred to as ME equipment: - intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening 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: