Recognized standard
18778 Second edition 2022-06
FDA recognition 1-159 · ISO · Anesthesiology
Key facts
| Recognition number | 1-159 |
|---|---|
| Designation | 18778 Second edition 2022-06 |
| Title | Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors |
| 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 infant cardiorespiratory monitor, as defined in 3.10, hereafter also referred to as ME equipment, in combination with its accessories: - intended for use in the home healthcare environment; - intended for use by a lay… |
At a glance
- None 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: