Recognized standard
80601-2-84 First edition 2020-07
FDA recognition 1-160 · ISO · Anesthesiology
Key facts
| Recognition number | 1-160 |
|---|---|
| Designation | 80601-2-84 First edition 2020-07 |
| Title | Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Dec 19, 2022 |
| Device classes | Class 2 |
| Scope (excerpt) | This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment: intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients… |
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: