| ISO 11073-91064 First edition 2009-05-01 Health informatics - Standard communication protocol - Computer-assisted electrocardiography |
| Recognition Date | 2015-08-14 |
| Recognition List | 040 |
| Recognition Number | 13-76 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Software/Informatics |
| FDA Tech | Konstantinos Makrodimitris FDA/OMPT/CDRH/ODE 301-796-6946 konstantinos.makrodimitris@fda.hhs.gov |
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ISO 11073-91064:2009 specifies the common conventions required for the cart-to-host as well as cart-to-cart interchange of specific patient data (demographic, recording, ...), ECG signal data, ECG measurement and ECG interpretation results.
ISO 11073-91064:2009 specifies the content and structure of the information that is to be interchanged between digital ECG carts and computer ECG management systems, as well as other computer systems where ECG data can be stored.
| Regulation Number | Device Name | Device Class | Product Code |
| §870.2920 | Transmitters And Receivers, Electrocardiograph, Telephone | Class 2 | DXH |
| §870.2340 | Electrocardiograph | Class 2 | DPS |
| §870.2340 | Monitor, St Segment | Class 2 | MLC |
| §870.2340 | Single Lead Over-The-Counter Electrocardiograph | Class 2 | OEY |
| §870.2300 | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Class 2 | DRT |
| §870.2300 | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Class 2 | MWI |
| §870.2300 | System, Network And Communication, Physiological Monitors | Class 2 | MSX |
| Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm, October 2003 Guidance for Industry: Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement), November 5, 1998 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Guidance for Industry and FDA Staff, 2005 Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff, 2014 |