FDA-recognized standard · Software/Informatics
ISO 11073-91064: Health informatics - Standard communication protocol - Computer-assisted electrocardiography
Yes. FDA recognizes ISO 11073-91064 First edition 2009-05-01 as recognition 13-76, entered 2015-08-14.
Recognized editions of ISO 11073-91064
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 13-76 | ISO 11073-91064 First edition 2009-05-01 | 2015-08-14 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 11073-91064: 21 CFR 870.2300, 21 CFR 870.2340, 21 CFR 870.2920.
Product codes that cite ISO 11073-91064
6 FDA product codes cite ISO 11073-91064, 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.