Recognized standard
81060-2 Third edition 2018-11 [Including AMD1:2020 and AMD2:2024]
FDA recognition 3-196 · ISO · Cardiovascular
Key facts
| Recognition number | 3-196 |
|---|---|
| Designation | 81060-2 Third edition 2018-11 [Including AMD1:2020 and AMD2:2024] |
| Title | Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: AMENDMENT 1 (2020) and AMENDMENT 2 (2024)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Cardiovascular |
| Date of entry | Dec 23, 2024 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies the requirements and methods for the clinical investigation of me equipment used for the intermittent non-invasive automated estimation of the arterial blood pressure by utilizing a cuff. This document is applicable to all sphygmomanometers that sense or display pulsations… |
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: