Recognized standard
11073-90101 First edition 2008-01-15
FDA recognition 13-68 · ISO · Software/Informatics
Key facts
| Recognition number | 13-68 |
|---|---|
| Designation | 11073-90101 First edition 2008-01-15 |
| Title | Health informatics - Point-of-care medical device communication - Part 90101: Analytical instruments -- Point-of-care test |
| Standards developer | International Organization for Standardization |
| Specialty area | Software/Informatics |
| Date of entry | Jul 9, 2014 |
| Device classes | Class 1 |
| Scope (excerpt) | ISO 11073-90101:2008 establishes a set of specifications to allow seamless multivendor interoperability and communication between point-of-care devices, data concentrators, and clinical information systems. CLSI document POCT1 provides the framework for engineers to design devices, workstations and… |
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: