Recognized standard
TIR80002-1:2009 TR 80002-1 Edition 1.0 2009-09
FDA recognition 13-34 · IEC · Software/Informatics
Key facts
| Recognition number | 13-34 |
|---|---|
| Designation | TIR80002-1:2009 TR 80002-1 Edition 1.0 2009-09 |
| Title | Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Software/Informatics |
| Date of entry | Jan 15, 2013 |
| Scope (excerpt) | IEC/TR 80002-1:2009(E) provides guidance for the application of the requirements contained in ISO 14971:2007, Medical devices - Application of risk management to medical devices to medical device software with reference to IEC 62304:2006, Medical device software - Software life cycle processes. It… |
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: