Recognized standard
11073-10701 First Edition, 2024-09 11073-10701-2022
FDA recognition 13-141 · ISO · Software/Informatics
Key facts
| Recognition number | 13-141 |
|---|---|
| Designation | 11073-10701 First Edition, 2024-09 11073-10701-2022 |
| Title | Health informatics - Device interoperability Part 10701: Point-of-care medical device communication - Metric provisioning by participants in a Service-oriented Device Connectivity (SDC) system IEEE Standard for Health Informatics - Device Interoperability - Part 10701: Point-of-Care Medical Device… |
| Standards developer | International Organization for Standardization |
| Specialty area | Software/Informatics |
| Date of entry | Dec 23, 2024 |
| Scope (excerpt) | This standard specifies a set of Participant Key Purposes (PKPs) pertaining to metric data exchange for the Service-oriented Device Connectivity (SDC) series of standards. PKPs are role-based sets of requirements for products in order to support safe, effective, and secure interoperability in… |
At a glance
- None 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: