Recognized standard
80601-2-49 Edition 1.1 2024-09 CONSOLIDATED VERSION
FDA recognition 3-203 · IEC · Cardiovascular
Key facts
| Recognition number | 3-203 |
|---|---|
| Designation | 80601-2-49 Edition 1.1 2024-09 CONSOLIDATED VERSION |
| Title | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Cardiovascular |
| Date of entry | Dec 22, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | IEC 80601-2-49:2018+AMD1:2024 CSV applies to basic safety and essential performance requirements of multifunction patient monitors, hereafter referred to as ME equipment or medical electrical systems. This particular standard applies to multifunction patient monitors intended for use in professional… |
At a glance
- 10–99 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: