Recognized standard
81060-3 First edition 2022-12
FDA recognition 3-188 · ISO · Cardiovascular
Key facts
| Recognition number | 3-188 |
|---|---|
| Designation | 81060-3 First edition 2022-12 |
| Title | Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type |
| Standards developer | International Organization for Standardization |
| Specialty area | Cardiovascular |
| Date of entry | May 29, 2023 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies the requirements and methods for the clinical investigation of continuous automated non-invasive sphygmomanometers used for the measurement of the blood pressure of a patient. This document does not cover usability aspects such as the form and manner of the data display or… |
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: