Recognized standard
82304-1 Edition 1.0 2016-10
FDA recognition 13-97 · IEC · Software/Informatics
Key facts
| Recognition number | 13-97 |
|---|---|
| Designation | 82304-1 Edition 1.0 2016-10 |
| Title | Health software - Part 1: General requirements for product safety |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Software/Informatics |
| Date of entry | Aug 21, 2017 |
| Scope (excerpt) | 1.1 Purpose This Part of 82304 applies to the safety and security of health software products designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for manufacturers. 1.2 Field of… |
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: