Recognized standard
80601-2-30: Edition 2.0 2018-03 80601-2-30:2018
FDA recognition 3-123 · IEC · Cardiovascular
Key facts
| Recognition number | 3-123 |
|---|---|
| Designation | 80601-2-30: Edition 2.0 2018-03 80601-2-30:2018 |
| Title | Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive… |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Cardiovascular |
| Date of entry | Jul 6, 2020 |
| Device classes | Class 2 |
| Scope (excerpt) | This International Standard applies to the basic safety and essential performance of automated sphygmomanometers, hereafter referred to as ME equipment, which by means of an inflatable cuff, are used for intermittent indirect measurement of the blood pressure without arterial puncture. |
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: