Recognized standard
62304 Edition 1.1 2015-06 CONSOLIDATED VERSION 62304:2006/A1:2016
FDA recognition 13-79 · IEC · Software/Informatics
Key facts
| Recognition number | 13-79 |
|---|---|
| Designation | 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION 62304:2006/A1:2016 |
| Title | Medical device software - Software life cycle processes Medical device software - Software life cycle processes [Including Amendment 1 (2016)] |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Software/Informatics |
| Date of entry | Jan 14, 2019 |
| Scope (excerpt) | IEC 62304:2006+A1:2015 Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes. Applies to the development and maintenance of medical device… |
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: