FDA-recognized standard · Software/Informatics
ISO IEEE 11073-10102: Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG
Yes. FDA recognizes ISO IEEE 11073-10102 First edition 2014-03-01 as recognition 13-75, entered 2015-08-14.
Recognized editions of ISO IEEE 11073-10102
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 13-75 | ISO IEEE 11073-10102 First edition 2014-03-01 | 2015-08-14 | Complete | — |
Regulations
FDA lists these classification regulations against ISO IEEE 11073-10102: 21 CFR 870.2300, 21 CFR 870.2340, 21 CFR 870.2920.
Product codes that cite ISO IEEE 11073-10102
6 FDA product codes cite ISO IEEE 11073-10102, including DPS, DRT, DXH, MLC, MSX.
- DPS Electrocardiograph
- DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- DXH Transmitters And Receivers, Electrocardiograph, Telephone
- 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.