FDA-recognized standard · Software/Informatics
IEEE 11073-10406-2011: Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
Yes. FDA recognizes IEEE Std 11073-10406-2011 as recognition 13-56, entered 2013-08-06. Its transition period ends 2027-07-04.
Recognized editions of IEEE 11073-10406-2011
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 13-56 | IEEE Std 11073-10406-2011 also ISO IEEE 11073-10406 First edition 2012-12-01 | 2013-08-06 | Complete | 2027-07-04 |
Regulations
FDA lists these classification regulations against IEEE 11073-10406-2011: 21 CFR 870.2300, 21 CFR 870.2340.
Product codes that cite IEEE 11073-10406-2011
5 FDA product codes cite IEEE 11073-10406-2011, including DPS, DRT, MLC, MSX, MWI.
- DPS Electrocardiograph
- DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- MLC
- MSX System, Network And Communication, Physiological Monitors
- MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
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.