FDA-recognized standard · Cardiovascular
IEC 80601-2-49: Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
Yes. FDA recognizes IEC 80601-2-49 Edition 1.1 2024-09 CONSOLIDATED VERSION as recognition 3-203, in part, entered 2025-12-22.
Recognized editions of IEC 80601-2-49
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 3-203 | IEC 80601-2-49 Edition 1.1 2024-09 CONSOLIDATED VERSION | 2025-12-22 | Partial | — |
What FDA does not recognize in IEC 80601-2-49 Edition 1.1 2024-09 CONSOLIDATED VERSION
Recognition 3-203 is partial. FDA's statement of the extent, verbatim:
Partial recognition. The following part(s) of the standard is (are) not recognized: Subclause 202.8.101 "IMMUNITY test setup" - Reference to table height (>= 0,4 m) for IMMUNITY testing in Figure 202.101.
Regulations
FDA lists these classification regulations against IEC 80601-2-49: 21 CFR 868.5895, 21 CFR 868.5915, 21 CFR 868.5925, 21 CFR 870.1025, 21 CFR 870.2300, 21 CFR 870.2340.
Product codes that cite IEC 80601-2-49
11 FDA product codes cite IEC 80601-2-49, including BTL, BTM, CBK, DRT, MHX.
- BTL
- BTM
- CBK Ventilator, Continuous, Facility Use
- DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- MLC
- MLD
- MNS
- MNT
- MSX System, Network And Communication, Physiological Monitors
- PLB
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.