Recognized standard
11073-91064 First edition 2009-05-01
FDA recognition 13-76 · ISO · Software/Informatics
Key facts
| Recognition number | 13-76 |
|---|---|
| Designation | 11073-91064 First edition 2009-05-01 |
| Title | Health informatics - Standard communication protocol - Computer-assisted electrocardiography |
| Standards developer | International Organization for Standardization |
| Specialty area | Software/Informatics |
| Date of entry | Aug 14, 2015 |
| Device classes | Class 2 |
| Scope (excerpt) | 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… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: